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RESEARCH ARTICLES
Polyetheretherketone cages used in anterior cervical discectomy and fusion surgery: a meta-analysis
Sukrit Sharma, Shakti Amar Goel, Sunil Sharma, Harvinder Singh Chhabra
April-June 2019, 4(2):29-33
DOI
:10.4103/2542-4157.259629
Background and objective:
In the current clinical scenario, a wide variety of fusion techniques are being used along with polyetheretherketone (PEEK) cages in anterior cervical discectomy and fusion surgeries. Some of these techniques involve use of autografts, allografts, biomaterials or only PEEK cages. In this study, the existing literatures for anterior cervical discectomy fusion surgeries using PEEK cages and their outcomes have been reviewed to evaluate the results for the best possible alternative.
Materials and methods:
A PubMed search for all papers stating “PEEK cages used in cervical spinal fusion,” “PEEK materials used in cervical spinal fusion,” and “artificial materials used in cervical fusion surgery with PEEK cages” was done for all studies before January 2018. A total of 197 studies were found, of which 15 were shortlisted as per the inclusion criteria. The existing literatures on PEEK cages used in spinal surgeries were reviewed and analyzed. Statistical analysis was done using SPSS software version 25.0 and Student’s
t
-test was used to compare the results.
Results:
The total number of patients involved in the existing study was 767 with a mean age of 51.67 ± 9.01 years. 191 patients (24.9%) had cervical radiculopathy or myelopathy; 35 patients (4.5%) had cervical degenerative diseases; 29 patients (3.78%) had cervical spine injury with monosegmental instability; and the rest of the patients suffered from other disorders. The level of surgery for patients was single in 429 patients (55.93%) and multiple in 338 patients (44.06%). PEEK plus bone grafts had a significantly better fusion rate compared with PEEK plus artificial materials (95% confidence interval: 91.075 ± 2.09%;
P
= 0.0035) for multiple-level anterior cervical discectomy and fusion surgery.
Conclusion:
PEEK plus bone grafts showed a significant fusion rate compared with PEEK plus artificial materials. PEEK plus bone grafts is a better filler material as compared to PEEK plus artificial materials in anterior cervical discectomy and fusion surgeries for multiple levels involved.
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Surgical site infections in orthopedic surgery: incidence and risk factors at an Iranian teaching hospital
Keykhosro Mardanpour, Mahtab Rahbar, Sourena Mardanpour, Nyousha Mardanpour
October-December 2017, 2(4):132-137
DOI
:10.4103/2542-4157.219372
Background and objectives:
Surgical site infection (SSI) is rare complication in orthopedic surgery and have serious consequences for outcomes and costs. Different risk factors may be involved, including age, sex, body mass index (BMI), prophylactic antibiotics, operation technique and duration, type of shaving, and length of hospitalization. This study aimed to determine the risk factors affecting orthopedic surgical site infections and their incidence at Imam Reza and Taleghani , two major referral teaching hospitals in west of Iran.
Design:
A prospective cohort study.
Methods:
A 36-month prospective cohort study, with 1 to 12 months of patient follow-up after surgery, was conducted at the teaching hospital in Iran. Patients (
n
= 1,900) who had undergone orthopedic surgery were studied between January 2012 and January 2015. Each patient was followed by pre- and post-operative examinations and telephone follow-ups.
Results:
Of the 1,900 patients, 73 suffered from SSI (3.84%). Methicillin Resistant
Staphylococcus aureus
(MRSA) 53% (
n
= 25) and Staphylococcus coagulase-negative 32% (
n
= 15) are the most common isolated germs. The smoking, high BMI, multiple fractures, increased operation time, increased bed stay, electivity of the operation, type of operation, using prosthetic implant and pre-operation of prophylactic antibiotic were all significantly associated with increased evidence of SSI (
P
< 0.04).
Conclusion:
Our study presented that stopping smoking, appropriate pre- and post-operational antibiotic prophylaxis regimens specially when using prosthetic implant, shortening duration of surgery and hospitalization and experience of the surgeon should be helpful to reduce rate of SSI.
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22,354
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REVIEWS
Preemptive analgesia in orthopedic surgery: a literature review
Juan Lopez Valencia, Anapaola Koch Leopo
October-December 2017, 2(4):144-152
DOI
:10.4103/2542-4157.219377
Pain after surgery is a maladaptive response. Acute postoperative pain is an important predictive factor for chronic post-surgical pain, which is observed in 10–65% of patients after surgery. Therefore controlling pain after surgery is very important. Reducing postoperative pain will result in more patient satisfaction, less complications due to immobility and decreased hospitalization periods. In this review, the use of preemptive analgesia in orthopedic surgery with a great variety of medications and interventions is examined. A search with the key words of “preemptive analgesia”, “orthopedic surgery” and “post-surgical pain” was conducted in online database PubMed, EBSCO, Elsevier (ClinicalKey), SpringerLink and OVID. Then selected articles from 5 years relevant with the application of preemptive analgesia in orthopedic surgery were analyzed. Finally we show some interventions with the outcomes and the challenges and new investigations suggested. The results showed that preemptive analgesia can be from regional blockade and local wound infiltration before incision to application of oral or intravenous medication before beginning surgery (NSAIDs, Gabapentin, Pregabalin, Dextromethorphan, Melatonin, Multimodal and Opioids) and the new approaches like transcutaneous electrical nerve stimulation (TENS). Preemptive analgesia has an important role in diminishing the pain rate in the post-surgical state, lowering pain medication intake and improving the patient satisfaction and early mobilization.
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STUDY PROTOCOL
Efficacy of silver needle acupuncture combined with muscle relaxation in the treatment of capulohumeral periarthritis: study protocol for a prospective, single-center, randomized, parallel-controlled trial
Jun-Min Yu, Jun-Jie Yu, Hui-Hui Cai, Chuan-Sheng Liu, Yan-Wei Yin, Feng-He Xu, Yu-Sheng Yi, Chao Meng
October-December 2018, 3(4):120-126
DOI
:10.4103/2542-4157.248610
Background and objectives:
Muscle relaxation therapy comprising general anesthesia and an intra-articular injection of betamethasone is commonly used to treat capulohumeral periarthritis. This treatment quickly improves the limited motion of the shoulder joint and restores the shoulder to its functional position, but cannot effectively inhibit the inflammatory response. Aseptic inflammatory pain can reportedly be relieved by silver needle acupuncture. However, there is insufficient high-quality evidence to validate the efficacy of silver needle acupuncture in the treatment of capulohumeral periarthritis. Therefore, the proposed study aims to evaluate the efficacy of silver needle acupuncture combined with muscle relaxation therapy in the treatment of capulohumeral periarthritis.
Design:
A prospective, single-center, open-label, randomized, parallel-controlled trial.
Methods:
Sixty patients with capulohumeral periarthritis will be assigned to receive either silver needle acupuncture plus muscle relaxation therapy (
n
= 30) or muscle relaxation therapy alone (
n
= 30). Patients will be followed up at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment.
Outcome measures:
The primary outcome measure is a Visual Analog Scale score obtained at 3 days post-treatment. The secondary outcome measures are: the Visual Analog Scale scores before treatment and at 14 days, and 1, 3, 6, and 12 months post-treatment; the Shoulder Joint Activity Function Rating Scale (Melle scale) score, American Shoulder and Elbow Surgeons Standardized Shoulder score, McGill Pain Questionnaire score, University of California at Los Angeles shoulder score before treatment and at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment; 12-item Short-Form Health Survey score at 1, 3, 6, and 12 months post-treatment; and the incidence of adverse events at 3 and 14 days, and 1, 3, 6, and 12 months post-treatment.
Conclusion:
The study results will provide evidence indicating whether silver needle acupuncture plus muscle relaxation is more effective than muscle relaxation alone in the treatment of capulohumeral periarthritis. We hypothesize that silver needle acupuncture plus muscle relaxation not only improves shoulder joint function, but also reduces inflammatory pain in the shoulder joint.
Ethics and dissemination:
This study was approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University of China on June 25, 2018 (approval No. QDDXFSYY-LL-06-25). This study will be performed in strict accordance with the
Declaration of Helsinki
formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from each participant. This study was designed in June 2018. Patient recruitment and data collection began in September 2018 and patient recruitment will end in April 2019. Result analysis will be performed in May 2020. This study will be scheduled to end in June 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.
Trial registration:
This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016706). Study protocol version: 1.0.
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COMMENTARIES
Assessing surgical methods for treatment of cubital tunnel syndrome - which is the best?
Karen E Burtt, Ido Badash, Brian Wu
July-September 2017, 2(3):123-124
DOI
:10.4103/2542-4157.213700
Cubital tunnel syndrome is a common and debilitating cause of upper extremity neuropathy. Several surgical options exist for treating this condition, including simple decompression, subcutaneous anterior transposition, and submuscular anterior translocation. The literature shows no clear differences in outcomes of these procedures. Consequently, the decision of which procedure to perform is often a matter of surgeon preference. Liu et al. has designed a blinded, randomized clinical trial to compare outcomes at 6 months postoperatively. This commentary addresses strengths and potential areas of improvement in the study protocol. With revision, the aforementioned study could provide clinical value in determining the ideal surgical option for cubital tunnel syndrome that maximizes reduction of symptoms while minimizing complications.
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RESEARCH ARTICLES
Platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures: study protocol for a prospective, randomized, controlled clinical trial
Zi-chun Zhao, Zhao-wei Li, Hong-xiu Yan, Bao-ming Tang, Chun-liang Li, Qi-fu Zhang, Rong Ren, Pei Li, Sheng-long Jia
April-June 2017, 2(2):78-84
DOI
:10.4103/2542-4157.207015
Background:
Internal and external fixation combined with autologous bone graft for the treatment of atrophic nonunion has a long treatment cycle, and there remain cases where the nonunion cannot be cured. Platelet-rich plasma contains a variety of growth factors and a large number of white blood cells, and contributes to tissue healing. However, there have been no clinical studies on the effectiveness of platelet-rich plasma combined with conventional surgery in the treatment of atrophic nonunion.
Methods/Design:
We conducted a prospective, open-label, randomized, controlled clinical trial at the Affiliated Hospital of Qinghai University, China. Ninety-two patients with atrophic nonunion of femoral shaft fractures were equally and randomly divided into a control group and an experimental group. The patients in the control group received conventional surgery, while the patients in the experimental group were injected with autologous platelet-rich plasma in addition to receiving conventional surgery. The primary outcome was fracture healing rate at 9 months postoperatively. The secondary outcomes were visual analogue scale scores for resting state and passive motion, healing time, treatment costs, and adverse reactions. Our partial results revealed that the visual analogue scale scores and complications were similar between the two groups on postoperative days 1–3. The healing rate was significantly higher in the experimental group compared with the control group. The healing time was significantly shorter in the experimental group compared with the control group.
Discussion:
The present trial was designed in August 2014, and case recruitment was completed in September 2016. Data for the last case will be collected in June 2018, and the data analysis will be completed in December 2018. The trial will provide objective data on the clinical use of platelet-rich plasma combined with conventional surgery for the treatment of atrophic nonunion.
Trial registration:
ClinicalTrials.gov identifier: NCT03129971.
Ethics:
The study protocol has been approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China (approval number: QHG0223A).
Informed consent:
Written informed consent was obtained from all participants.
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REVIEWS
Recent advancements in magnesium implants for orthopedic application and associated infections
Jaslin P James
October-December 2016, 1(4):138-144
DOI
:10.4103/2542-4157.194813
In recent years extensive research on magnesium and its alloys as potential biodegradable implant materials have been carried out by various research groups around the world. Biodegradable magnesium alloys are more suitable for load-bearing implant applications than their polymeric counterparts because of their superior mechanical strength. Moreover, since their elastic properties resemble those of natural bone, they are considered ideal for hard tissue implants employed in fracture stabilization so that stress shielding is avoided and bone regeneration is enhanced. Also studies have shown that Mg alloy exhibit good biocompatibility with no systemic inflammatory reaction or affection of the cellular blood composition. One of the main advantages of biodegradable implants is the elimination of follow-up surgery to remove the implant after the tissue has healed sufficiently. Consequently, extensive studies have been carried out to develop Mg-based alloys with superior mechanical and corrosion performance. This review focuses on the following topics: (i) the design criteria of biodegradable materials; (ii)
in vitro
performances of currently developed magnesium alloys; (iii) improving properties of Mg based orthopedic implants using surface improvement techniques and other alloying methods; as well as (iv) implant infections and current methods.
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STUDY PROTOCOL
Treatment of intertrochanteric femoral fracture with proximal femoral medial sustainable intramedullary nails: study protocol for a randomized controlled trial
Peng-bin Yin, An-hua Long, Jing Shen, Pei-fu Tang
April-June 2016, 1(2):44-50
DOI
:10.4103/2468-5674.183001
Background:
Conservative management of intertrochanteric femoral fracture often yields poor therapeutic outcomes, and surgical fixation is generally warranted. Biomechanical instability of intertrochanteric femoral fracture is a major cause of fixation failure. To increase the stability of intramedullary nails in intertrochanteric femoral fracture, it is critical to strengthen the support between the nail and the cortical bone. Our previously designed proximal femoral medial sustainable intramedullary nail has been proven to be able to provide this internal support and stabilization by finite element analysis. We aim to examine the efficacy and safety of internal fixation with this new type of intramedullary nail in the treatment of stable and unstable intertrochanteric femoral fractures.
Methods/Design:
This will be a single-center, two-arm, parallel, randomized controlled trial conducted at the Chinese PLA General Hospital, China. Seventy-two patients with stable or unstable intertrochanteric femoral fracture diagnosed according to AO/OTA Classification of Fractures and Dislocations will be randomly assigned to receive internal fixation either with proximal femoral medial sustainable intramedullary nails, or proximal femoral nail antirotation. The primary outcome measure will be bone healing condition 6 months postoperatively; secondary outcomes will be requirement for revision surgery, quality of life and complications 1 year postoperatively.
Discussion:
Our findings will provide an evidence base for the use of proximal femoral medial sustainable intramedullary nails for the treatment of intertrochanteric femoral fracture.
Trial registration:
ClinicalTrial.gov identifier: NCT01437176; registered on 1 September 2011.
Ethics:
This protocol was approved by Ethics Committee of Chinese PLA General Hospital of China (approval No. 07/06/2011) and will be performed in accordance with the
Declaration of Helsinki
formulated by the World Medical Association.
Informed consent:
Written informed consent will be obtained prior to involvement in the clinical trial.
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Minimally invasive treatment of proximal humerus fractures with locking compression plate improves shoulder function in older patients: study protocol for a prospective randomized controlled trial
Tao Wu, Guo-qiu Zhang
April-June 2016, 1(2):51-57
DOI
:10.4103/2468-5674.183002
Background:
Manual reduction or traditional steel plate fixation is commonly used for repair of proximal humerus factures in older patients, making these injuries prone to fracture malunion because of poor stability. While open reduction with steel plate fixation has a better outcome than closed reduction, the stability of internal fixation is still less than satisfactory. Therefore, we hypothesize that use of a locking compression plate will provide better stability and that biocompatibility will potentiate fracture healing and shoulder function recovery in older patients with proximal humerus fractures. This hypothesis is based on the fact that minimally invasive treatment with locking compression plates has presented good clinical results in terms of fixation stability, bone healing, and functional recovery.
Methods/Design:
This prospective, single-center, randomized controlled clinical trial will be completed at the Department of Joint Surgery, Affiliated Hospital of Qinghai University in China. Eighty-two older patients with proximal humerus fractures will be enrolled and equivalently assigned to two groups. In the test group, patients will undergo closed reduction
via
a lateral approach to the shoulder followed by locking compression plate fixation using a minimally invasive technique, and those in the control group will be subjected to closed reduction
via
a lateral approach to the shoulder followed by conventional steel plate fixation using a minimally invasive technique. All patients will be followed up for 6 months. The primary outcome will be recovery of shoulder function as indicated by clinical outcome scores according to the Neer classification system for proximal humeral fractures 6 months after surgery. The secondary outcomes will include the operation time; intraoperative blood loss; postoperative hospital stay; fracture healing time; clinical outcome scores according to the Neer classification system 0.5, 1, and 3 months after surgery; Visual Analogue Scale scores 1 and 3 days and 1 and 2 weeks after surgery to assess pain; scores of the Medical Outcomes Study 36-item Short Form Health Survey 0.5, 1, 3, and 6 months after surgery to assess quality of life; and X-ray examinations 0.5, 1, 3, and 6 months after surgery to assess fracture healing.
Discussion:
This study protocol represents an attempt to objectively choose appropriate methods for internal fixation of proximal humerus fractures in older patients by comparing locking compression plate with conventional steel plate fixation to improve shoulder function.
Trial registration:
ClinicalTrial.gov identifier: NCT02784522.
Ethics:
This study acquired written approval from the Ethics Committee of the Affiliated Hospital of Qinghai University in China (approval No. QHY1005D); this study will be performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Written informed consent will be obtained prior to involvement in the clinical trial.
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Minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for repair of distal radius fracture: study protocol for a randomized controlled trial
Zhi Li
April-June 2016, 1(2):58-63
DOI
:10.4103/2468-5674.183003
Background:
Conventional open reduction internal fixation and external fixation are not ideal treatment options for distal radius fracture. Minimally invasive surgery for distal radius fracture results in less trauma than other techniques; fully threaded headless cannulated compression screws can increase the stability of fracture fragments and contribute to functional recovery after wrist fracture. In this proposed study, we hypothesize that minimally invasive closed reduction and internal fixation of distal radius fracture with fully threaded headless cannulated compression screws will promote functional recovery of the wrist joint.
Methods/Design:
In this prospective, randomized, controlled trial, we will recruit 60 outpatients with distal radius fracture from the Department of Orthopedic Surgery, Central Hospital Affiliated to Shenyang Medical College, China. Patients will be assigned to one of two treatment groups: C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws (experimental group) or open reduction (palmar and dorsal incisions) and internal fixation with titanium plate (control group). Internal fixation will be maintained for 24 weeks in both groups. Our primary outcome measures will be X-ray and CT examinations 24 weeks after surgery. Secondary outcome measures include patient-rated wrist evaluation scores, used to evaluate wrist joint function; fracture healing time; and Visual Analogue Scale score, used to evaluate the severity of the patient's pain.
Discussion:
With this study we hope to confirm that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws for distal radius fracture repair has advantages over conventional open reduction internal fixation with titanium plates, providing superior fragment stability and allowing for early rehabilitation exercise of the wrist joint, which improves recovery of function. We hope to show that minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws is the more suitable surgical method for repair of distal radius fracture.
Trial registration:
ClinicalTrial.gov identifier: NCT02784678.
Ethics:
The study protocol was approved by the Ethics Committee of Central Hospital Affiliated to Shenyang Medical College, China. The trial protocol will be performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Prior to the trial, patients and their family members will be informed of the risks and benefits of this trial. Signed informed consent will be obtained from each patient.
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RESEARCH ARTICLES
Risk factors for ligamentum flavum hypertrophy in lumbar spinal stenosis patients from the Xinjiang Uygur Autonomous Region, China: protocol for a retrospective, single-center study
Gang Zhou, Yu-kun Zhang, Wei-min Huang
January-March 2017, 2(1):11-17
DOI
:10.4103/2542-4157.201057
Background:
Ligamentum flavum hypertrophy is one important cause of spinal stenosis. Ligamentum flavum thickness of more than 4 mm measured on computed tomography (CT) and magnetic resonance imaging is considered hypertrophy, but causes of hypertrophy and distribution characteristics remain poorly understood. Previous studies showed that the ligamentum flavum thickness at the segments L
2/3
, L
3/4
, L
4/5
and L
5
/S
1
was positively correlated with age. It remains unclear whether ligamentum flavum thickness is associated with nationality, sex and obesity.
Methods/Design:
We conducted a retrospective, single-center, case analysis at the Sixth Affiliated Hospital, Xinjiang Medical University, China. We collected lumbar CT imaging data of 104 patients diagnosed with lumbar spinal stenosis in the Sixth Affiliated Hospital, Xinjiang Medical University from May 2012 to May 2016. The primary outcome was the ligamentum flavum thickness of patients with different nationalities, sexes, heights, ages, and weights. The secondary outcomes were the morphology of lumbar vertebrae in patients with different nationalities, sexes, heights, ages, and weights; the correlation of nationality, sex, height, age, and weight with ligamentum flavum thickness; results of multiple linear regression analysis of relevant factors for ligamentum flavum hypertrophy.
Discussion:
This study will determine the variations in the ligamentum flavum thickness of lumbar spinal stenosis patients of different nationalities, sexes, heights, ages, and weights in the Xinjiang Uygur Autonomous Region by measuring the ligamentum flavum thickness using CT, and analyzing risk factors for ligamentum flavum hypertrophy; the findings will provide quantitative reference data for preventing lumbar spinal stenosis induced by ligamentum flavum hypertrophy in the Xinjiang Uygur Autonomous Region.
Trial registration:
ClinicalTrials.gov identifier: NCT03057353.
Ethics:
The study protocol has been approved by the Ethics Committee of Sixth Affiliated Hospital, Xinjiang Medical University, China, and conducted in accordance with the
Helsinki Declaration
, formulated by the World Medical Association.
Informed consent:
Written informed consent was obtained from all participants.
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32,440
1,291
Effects of lumbar plexus-sciatic nerve block combined with sevoflurane on cognitive function in elderly patients after hip arthroplasty: study protocol for a prospective, single-center, open-label, randomized, controlled clinical trial
Yan-hong Guo, A Liang-de, Zhen Jia
April-June 2017, 2(2):71-77
DOI
:10.4103/2542-4157.207014
Background:
Elderly patients often suffer from postoperative cognitive dysfunction after total hip arthroplasty, but the precise mechanism remains unclear. Sevoflurane regulates the concentration of basic fibroblast growth factor in the brain, but it is not known whether sevoflurane can decrease cognitive dysfunction after hip arthroplasty. We hypothesized that lumbar plexus-sciatic nerve block combined with sevoflurane could reduce the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.
Methods/Design:
We conducted a prospective, single-center, open-label, randomized, controlled clinical trial at the Affiliated Hospital, Qinghai University, China. Seventy elderly patients undergoing unilateral total hip arthroplasty were randomized into two groups. All patients underwent endotracheal intubation and mechanical ventilation. In the experimental group, a lumbar plexus-sciatic nerve block was performed and general anesthesia was maintained with sevoflurane. In the control group, general anesthesia was maintained with intravenous propofol. Outcomes were measured preoperatively and on the first and third postoperative days. The primary outcome measure was the Mini-Mental State Examination, and the secondary outcomes were the Montreal Cognitive Assessment, serum basic fibroblast growth factor concentration, intraoperative blood loss, and operation time. The other outcome was the incidence of intraoperative and postoperative adverse events.
Discussion:
This trial examined whether lumbar plexus-sciatic nerve block combined with sevoflurane reduced the incidence of cognitive dysfunction in elderly patients after hip arthroplasty, documented the changes in serum basic fibroblast growth factor concentration, and further explored the therapeutic mechanism of sevoflurane.
Trial registration:
ClinicalTrials.gov identifier: NCT03162861.
Ethics:
The study protocol has been approved by the Ethics Committee of Affiliated Hospital of Qinghai University of China. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association.
Informed consent:
Written informed consent was provided by participants prior to enrollment in the trial.
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768
Functional outcomes and health-related quality of life after open repair of rotator cuff tears: a prospective cohort study
Joel Galindo-Avalos, Oscar Medina-Pontaza, Juan López-Valencia, Juan Manuel Gómez-Gómez, Avelino Colin-Vázquez, Rubén Torres-González
January-March 2018, 3(1):1-6
DOI
:10.4103/2542-4157.227045
Background and objectives:
Rotator cuff tears are a common cause of shoulder pain, that can diminish a patient’s functionality and quality of life. The objective of this study was to assess the effectiveness of open repair of rotator cuff tears by evaluating functional outcomes and health-related quality of life.
Design:
A prospective cohort study.
Methods:
We evaluated the functional outcome and health-related quality of life (HRQoL) of 120 patients with rotator cuff tears, aged 40 to 65 years, repaired by an open technique applying two questionnaires, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) and a shortened form (12 items) of the Short Form 36 Health Survey version 2 (SF12v2) preoperatively, and at 3, 6 and 12 months postoperatively. Functional outcomes were categorized as Excellent (88–100), Good (75–87), Fair (62–74) or Bad (61 or less) depending on the ASES score. The HRQoL was divided into its physical and mental components (physical component summary (PCS) and mental component summary (MCS), respectively) by using QualityMetric Health Outcomes™ version 4.5, and was categorized as under the norm, at the norm, or above the norm. We also evaluated if a relationship existed between sex, side, tear size, or tear pattern, with the functional outcome or the HRQoL.
Results:
We found a statistically significant difference between the preoperative ASES and PCS scores with the 6- and 12-month follow-up results and between preoperative MCS score with the 12-month follow-up result (
P
< 0.05). We found no correlation between functional outcome and HRQoL; or between sex, side, tear size, or tear pattern, with the functional outcome and HRQoL (
P
> 0.05).
Conclusion:
Open repair of rotator cuff tears remains a valid and effective option, despite the current trend of arthroscopic repair, obtaining satisfactory results at around 6 months after surgery.
Trial registration:
This study was registered at SIRELCIS, with the identifier R-2011-3401-43 CLIS 3401.
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Evaluation of a computer-assisted orthopedic training system for learning knee replacement surgery: a prospective randomized trial
Jie Xu, Deng Li, Bing Xu, Zhi-qing Cai, Ying-bin Zhang, Ruo-fan Ma
January-March 2018, 3(1):7-11
DOI
:10.4103/2542-4157.227047
Background and objectives:
As conventional knee replacement training requires bone model, computer-assisted simulation seems to be an attractive alternative. Therefore, we compared the transfer of conventional training for the knee replacement and computer-assisted simulation to surgery in this trial.
Design:
A prospective randomized trial.
Methods:
The study was performed in Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. After completing an intensive course in basic theory of total knee arthroplasty (TKA), three groups of 10 participants proceeded with no additional training (control group), 5 hours of conventional training on bone model (model training group) or simulation TKA training on the computer-assisted orthopedic training system (CAOS training group). Participants were evaluated during a TKA based on a bone model at baseline, 1 week and 4 months after training.
Results:
The CAOS training group performed the procedure significantly better than the other two groups at posttesting (
P
< 0.05). CAOS training group performing the procedure better than the model training group was identified at retention testing but this did not reach statistical significance.
Conclusion:
These results indicated that this computer-assisted training system was able to produce the effect of learning TKA skill, and it could provide a training alternative for novices. Meanwhile, it could enhance student learning through increased motivation.
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Developing a consensus on indications, timing and core outcomes for surgical fixation of rib fracture: a Delphi technique protocol
Helen MA Ingoe, Catriona McDaid, William Eardley, Catherine Hewitt
April-June 2018, 3(2):37-42
DOI
:10.4103/2542-4157.233622
Background and objectives:
Developing a robust surgical trial requires evidenced based indications and selection of relevant outcomes. The aim of this study is to develop a consensus on indications and timing and a core outcome set for surgical fixation of rib fractures following blunt chest trauma.
Design:
A systematic review of the literature and identification of a core outcome set using a Delphi survey.
Methods:
Systematic review has identified multiple outcomes, indications and timing of surgery following rib fracture fixation. Using the Core Outcomes Measures in Effectiveness Trials (COMET) methodology, three expert panels including clinicians, allied health professionals and patients will be invited to participate in an online questionnaire. Consensus will be achieved after three rounds using a rating scale of 1 (not important) to 9 (critically important). Those responses unable to gain consensus will be dropped through subsequent rounds. All three expert panels will take part in the development of a core outcome set. Clinicians will run a concurrent consensus on timing and indications for surgery.
Discussion:
A consensus on the indications, timing and outcomes that should be measured in a surgical rib fracture fixation trial is required to address in ability to compare multiple studies for evidence synthesis.
Ethics and dissemination:
Ethics approval has been obtained from the University of York Health Science Research Governance Committee, Health Research Authority (235596) and North West Research Ethics Committee (18/WM/0018). Systematic review is complete, and the consensus rounds will take place between February and June 2018. Protocol version: 2.0. The results of the study will be disseminated in a peer-reviewed journal.
Trial registration:
This protocol was registered on the COMET website
http://www.comet-initiative.org/studies/details/1104
.
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Stratification of injuries to the lateral collateral ligament of the ankle using ultrasound: protocol of a prospective, open-label, diagnostic trial and preliminary results
Dan Huang, Xiu-Zhen He, Xu-Huan Yang, Si-Min Peng, Ying-Xian Wu
April-June 2018, 3(2):53-58
DOI
:10.4103/2542-4157.233637
Background and objectives:
Patients with ankle sprain most commonly experience injuries to the lateral collateral ligament (LCL) complex, which affects the stability and function of the ankle. Early diagnosis of LCL complex injuries is extremely important. In clinical practice, magnetic resonance imaging (MRI) displays the soft tissues of the ankle well, but it is expensive and cannot be used for real-time evaluation. Ultrasound (US) has the advantages of ease of operation, low cost, and real-time capability. Some studies have reported on the stratification of injuries to the LCL complex using US. However, there is controversy regarding the injury grading. The purpose of this study was to investigate the grading of LCL complex injuries (sprain, partial tear, and complete tear) using US.
Design:
A prospective, open-label, diagnostic trial.
Methods:
Seventy patients with suspected ankle sprain who have an acute ankle sprain history and present with surgical indicators will be scheduled to receive ankle ligament repair surgery in the Guangzhou Orthopedics Hospital, China. On the day after admission, these patients will undergo US and magnetic resonance imaging (MRI) of the injured ankle prior to ankle ligament repair surgery (test group). The contralateral ankle will be included in the control group and will also undergo MRI and US examination prior to surgery. MRI or surgical results will be used as the gold standard for diagnosing LCL complex injuries. The feasibility of stratification of LCL complex injuries (sprain, partial tear, and complete tear) using US will be evaluated.
Outcome measures and preliminary results:
The primary outcome measure of this study is the sensitivity of US in the diagnosis of complete LCL complex tear. The secondary outcome measures are the sensitivity of US in the diagnosis of sprain and partial tear of the LCL complex; the specificity, positive predictive value, negative predictive value, accuracy, area under the ROC curve (AUC), and cut-off value of US in the diagnosis of sprain, partial tear, and complete tear of the LCL; and US imaging for the anatomy of the LCL complex. The results of 53 patients with acute ankle sprain included in the preliminary study suggest that there is no significant difference in the type of injuries to the talofibular ligament and calcaneofibular ligament between ultrasound diagnosis results and surgical or MRI findings (
P
> 0.05).
Discussion:
The results of this study will reveal whether US has a higher diagnostic value than MRI in the diagnosis of injuries to the LCL complex.
Ethics and dissemination:
This study was approved by Medical Ethics Committee of Guangzhou Orthopedics Hospital, China in May, 2018 (approval No. 2018-05). This study protocol will be performed in strict accordance with the
Declaration of Helsinki
. The personal information and data of the testing subjects participating in the clinical trials will be confidential and will be protected in accordance with applicable laws and regulations. The study protocol was designed in February 2018. Patient recruitment will begin in August 2018 and end in August 2019. Data collection will begin in August 2018. Data analysis will be performed in December 2019. The study will end in March 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.
Trial registration:
This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800016244). Protocol version: 1.0.
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Clinicopathological characterization of long bone non-union: a prospective cross-sectional study
Avelino Colin-Vazquez, Luis Dario Bernal-Fortich, Joel Galindo-Avalos, Juan López-Valencia, Rafael Grajales-Ruiz, Adrián Miguel-Pérez, Jorge Quiroz-Williams, Elizabeth Pérez-Hernández
October-December 2018, 3(4):101-106
DOI
:10.4103/2542-4157.248607
Background and objectives:
The exact biological process that leads to a non-union remains obscure and it is well accepted that any intervention to reverse this process must be timely and well directed to re-establish both biological and mechanical deficiencies. The purpose of the present work was to identify the possible morphological patterns of bone tissue in a state of non-union and in the presence or absence of infection.
Methods:
A prospective, observational, cross-sectional study was performed. Bone tissue samples obtained from patients with radiologically and clinically diagnosed long bone non-union undergoing revision surgery were included, without distinction of age and sex. Histopathological analysis and semiquantitative evaluation of tissue samples were performed using conventional optical microscopy. Clinical data related to the study variables were obtained, such as type of consolidation, time of evolution, and corresponding bacteriological analysis.
Results:
Several morphological pattern variables such as bone quality, osteosclerosis, areas of bone devitalization, osteoclastic activity, vascularization, and in particular cell density were related to the subtype of long bone non-union. They were also associated with septic and aseptic variants of long bone non-union.
Conclusion:
The biological bone profiles, in particular the histomorphological characteristics, are related to the subtype of non-union and reflect the physiopathological environment that involves an anabolic and catabolic imbalance. These can be incorporated into the classification system and favor the stratification of non-union.
Ethics and trial registration:
This study was approved by Comité Local de Investigación y Ética en Investigación en Salud at UMAE “Dr. Victorio de la Fuente Narváez” (R-2017-3401-8) on July 19, 2017 and registered with SIRELCIS (identifier: R-2017-3401-8).
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REVIEWS
Venous thromboembolism in the setting of orthopedic trauma surgery
Ido Badash, Emily G Pott, Brian W Wu
October-December 2016, 1(4):128-137
DOI
:10.4103/2542-4157.194812
Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, can result in serious medical complications and is the leading cause of preventable hospital deaths. Risk of VTE is especially concerning in orthopedic trauma, where VTE incidences of up to 80% can result in significant morbidity following surgery. Studies investigating VTE in orthopedic trauma have identified predisposing factors for VTE that can be used to stratify patients for risk of developing thrombosis. Additionally, an assortment of diagnostic procedures may be used to reliably detect or exclude VTE, and various methods of VTE prophylaxis has been shown to reduce patient morbidity and mortality. However, many orthopedic trauma patients who present with known risk factors still do not receive the prophylaxis they need, and hospital resources may be misused when inappropriate diagnostic tests are ordered. As a result, it is critical for physicians working in orthopedic trauma to be aware of validated methods for VTE management, including known risk factors, diagnostic tools, and prophylactic methods, to appropriately and efficiently manage VTE. The purpose of this review is to centralize information about the management of VTE in orthopedic trauma. Articles included were selected from leading journals and online databases based on their scientific merit and applicability to clinical orthopedics. By consolidating information about VTE management, it will be possible to identify areas that need further research and ultimately create guidelines that standardize the treatment of VTE in orthopedic trauma across multiple institutions.
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STUDY PROTOCOL
Digital navigation enhances cervical pedicle screw placement accuracy and safety: study protocol of a randomized controlled trial
Jun-jie Guan
July-September 2016, 1(3):106-111
DOI
:10.4103/2468-5674.189509
Background:
A unified standard for cervical pedicle screw placement does not currently exist; therefore, it is difficult to quantitatively evaluate the clinical effects of the technique. Digital navigation can provide a reference for accurate and safe location, orientation, and placement of cervical pedicle screws. We hypothesized that compared with partial cervical lamina excision or the pipeline-dredge discharge method, digital navigation can greatly increase the accuracy and safety of cervical pedicle screw placement.
Methods/Design:
This was a prospective, single-center, randomized controlled, open-label trial. Seventy-six patients with cervical spine fracture scheduled to receive treatment in the Department of Orthopedics, Affiliated Hospital of Nantong University, China were randomly divided into three groups to undergo cervical pedicle screw internal fixation. Patients in the cervical lamina partial excision group (
n
= 26, 160 screws) underwent partial cervical lamina excision and cervical pedicle screw internal fixation; those in the pipeline-dredge discharge group (
n
= 27, 156 screws) underwent pipeline-dredge discharge and cervical pedicle screw internal fixation; and those in the digital navigation group (
n
= 23, 162 screws) underwent digital navigation-assisted cervical pedicle placement. All patients were evaluated at 12 and 36 months. The primary outcome was the percentage of screws graded I when evaluating the penetration degree of the cervical pedicle screws, which evaluates the accuracy of screw placement, 12 months after internal fixation. Secondary outcomes included: (1) the percentage of screws graded I when evaluating the penetration degree of cervical pedicle screws 36 months after internal fixation; (2) bony fusion rate of the atlantoaxial joint, used to evaluate fracture healing, 12 and 36 months after internal fixation; (3) Visual Analogue Scale spine score, used to evaluate cervical neck pain, prior to and 12 and 36 months after internal fixation; (4) American Spinal Injury Association Classification, used to evaluate improvement in neurological function, prior to and 12 and 36 months after internal fixation; and (5) adverse events, used to evaluate the safety of each pedicle screw implantation method, 12 and 36 months after internal fixation.
Discussion:
This trial protocol compared the effects of three cervical pedicle screw internal fixation methods for the treatment of cervical spine fracture, and investigated and compared the accuracy and safety of digital navigation-assisted cervical pedicle screw placement with partial cervical lamina excision and pipeline-dredge discharge. We hoped to provide quantitative evidence for the clinical use of digital navigation in orthopedics, especially in cervical pedicle screw placement.
Trial registration:
ClinicalTrial.gov identifier: NCT02880839; registered on 19 August 2016.
Ethics:
This trial protocol has been approved by Medical Ethics Committee, Affiliated Hospital of Nantong University, China, and was performed in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Signed informed consent regarding trial procedure and treatment was obtained from each patient.
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Comparing unicompartmental to total knee arthroplasty in medial gonarthritis: study protocol for 2-year follow-up of a randomized controlled trial
Carl Aulin, Nicolas Martinez-Carranza, Johan Fyhrlund, Hans E Berg, Margareta Hedström
July-September 2018, 3(3):74-80
DOI
:10.4103/2542-4157.233632
Background and objectives:
Since the 1990s, unicompartmental knee arthroplasty (UKA) are again starting to gain interest worldwide. A mere 3.5% of all knee arthroplasties performed in Sweden 2014 were UKAs, whereas up to 25% had knee osteoarthritis isolated to the medial side. Reasons for this discrepancy might be that UKAs are considered more technically demanding, thus requiring more surgical training, and that long-term survival of these implants has been inferior compared to total knee arthroplasty (TKA). This has been addressed by improving surgical instruments and discontinuation of underperforming implants, and by improving surgical technique including mini-invasive incision and patient selection. In support of using the less surgically invasive UKA, a few cohort studies show less pain, fewer hospital days, and faster rehabilitation. However, to the best of our knowledge, there is a lack of high quality randomized clinical trials (RCTs) showing unequivocal clinical superiority of UKA compared to TKA. The aim of the present study is to compare changes in muscle mass, strength, performance based measures (PBMs), and patient reported outcome measures (PROMs) in patients randomized to UKA or TKA.
Design:
A 2-year follow-up RCT.
Methods:
The study will include 80 patients with medial knee osteoarthritis, aged 50 years or more, who will be scheduled for a knee replacement and equally randomized to either TKA or UKA.
Outcome measures:
The primary outcome is muscle mass change at 6 weeks, 6, 12 and 24 months post-operatively measured by computed tomography. Secondary outcomes are PBMs, PROMs, muscle strength, and 3D motion analysis at the same occasions.
Discussion:
Although patients subjected to total hip arthroplasty are typically satisfied with their surgical results, patients with TKA are less so. It is of importance to improve surgical procedure, and less invasive surgery of the knee might be a solution.
Ethics and dissemination:
The study has been approved by the Regional Ethics Committee in Stockholm (DNR: 2014/1895-31/3) and will be conducted in accordance with the ethical principles of the
Declaration of Helsinki
. All patients will sign a consent form after being given oral and written information of the study. Patient recruitment began in November 2015 and will end in December 2019. Data collection will complete in June 2021. We plan to present results in open access scientific publications and at scientific conferences and meetings.
Trial registration:
The study protocol was registered with ClinicalTrials.gov (identifier: NCT 02563756) on September 18, 2015. Protocol version: 1.0.
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Effects of balance training prior total knee replacement surgery: study protocol for a randomized controlled trial
José-María Blasco, Fernando Dominguez-Navarro, Celedonia Igual-Camacho, Antonio Silvestre-Muñoz, Sergio Roig-Casasús
January-March 2018, 3(1):12-17
DOI
:10.4103/2542-4157.227050
Background and objectives:
Many functional limitations following total knee replacement are related to balance. This trial aims to determine the short and long-term effects on balance and functionality of a preoperative muscle enhancement program that includes a specifically oriented protocol of balance and proprioception training in the methods.
Design:
Prospective three-arm, randomized controlled trial.
Methods:
Seventy-eight participants will be will be recruited from Hospital Clínico y Universitario de Valencia in Spain, and randomly divided into three equal groups: a control group, a active comparator which performs a program for muscle enhancement preparatory for surgery, and a experimental group which additionally includes a program oriented to enhance balance and proprioception.
Outcome measures:
The primary outcome measures are overall balance assessed by the Berg Scale and self-reported functionality measured by the Knee Injury Osteoarthritis Outcome Function Score. Secondary outcomes include stability, dynamic and static balance abilities, anxiety-depression, and knee function. Outcomes will be assessed prior to intervention, 2 weeks, 6 weeks and 1 year after surgery. A cost effectiveness-analysis will be conducted based on the quality adjusted life years gained.
Discussion:
The results will help to appraise the early-postoperative effects in terms of balance and functionality. This research will also appraise the cost-effectiveness of the proposal, based on data extracted from long-term evaluations.
Ethics and dissemination:
The trial was approved by the Ethics and Scientific Committee of the Clinical and University Hospital of Valencia (26052016). Early-postoperative outcomes will be likely available by November 2018. Follow-up will be completed by the end of 2019. The results will be disseminated through workshops, peer-reviewed publications, and local and international conferences.
Trial registration:
ClinicalTrials.gov identifier: NCT02995668.
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Total hip arthroplasty
via
the direct anterior approach
versus
lateral approach: study protocol for a randomized controlled trial
Dan Viorel Nistor, Sergiu Caterev, Nicolae Ciprian Bota, Dan Osvald Gheorghe Lucaciu, Adrian Todor
January-March 2018, 3(1):18-23
DOI
:10.4103/2542-4157.227048
Background and objectives:
Total hip replacement is evolving to be more refined, especially through the development of muscle sparing approaches such as the direct anterior approach (DAA), bone preserving prosthesis, as well as the use of a fast tracking protocol. Despite the rising interest in the DAA, its attribute and benefits as a muscle sparing approach continue to be debated. While some advocates of this procedure report a faster recovery, lower postoperative pain levels and lower dislocation rates, there are some studies describing higher complication rates specific to the approach, longer setup and surgery time, as well as muscle damage similar to classic approaches, especially in complex cases. We aim to establish if the total hip replacement through the DAA results in lower muscle damage, faster recovery and better overall clinical outcomes when compared to the classic lateral approach.
Design:
This will be a single-center, single surgeon, randomized controlled trial.
Methods:
Two hundred patients diagnosed with end-stage primary degenerative hip arthritis confirmed on plain radiographs will be randomly assigned to undergo a primary total cementless hip arthroplasty
via
the direct anterior approach or the lateral approach. The primary goal of this study is to determine if the direct anterior approach is less invasive and if this yields superior clinical outcomes.
Outcome measures:
The primary outcome is muscle damage assessment using Myoglobin and Troponin as biomarkers. Secondary outcomes include functional outcome measures Oxford Hip Score, Harris Hip Score and quality of life 36-Item Short-Form Health Survey, physical recovery tests, complication rates, postoperative pain levels (daily for the 1
st
week and weekly for the first 3 months, as well as 6, 12 and 24 months after surgery), rescue medication consumption, prosthesis component positioning evaluated on radiographs, as well as perioperative data (
i.e
., surgery and setup time, incision length, blood loss, length of hospital stay, time to cessation of walking aids) and other biomarkers for muscle damage and inflammatory responses (
i.e
., creatine kinase, lactate dehydrogenase, aspartate aminotransferase and C-reactive protein).
Discussion:
This study represents a pursuit to provide an evidence based enquiry upon the muscle sparing benefits of the total hip replacement
via
the direct anterior approach relative to the lateral approach.
Ethics and dissemination:
This study was approved by the University of Medicine and Pharmacy Cluj-Napoca Ethics Committee (517/2015) and it will be performed in accordance with the guidelines of the
Declaration of Helsinki
. Written informed consent will be obtained from all patients prior to recruitment in this study. The results of the trial will be published in a peer-reviewed journal and will be disseminated
via
various forms of media.
Trial registration:
ClinicalTrial.gov identifier: NCT02719236.
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A new fixation and reconstruction method
versus
arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results
Guang-dong Chen, Yang Zhang, Yong-jian Ni, Hong-mei Du, Tong-jun Cao, Zhong-lin Shan
January-March 2018, 3(1):24-31
DOI
:10.4103/2542-4157.227049
Background and objectives:
Arthroscopic reconstruction for treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament (PCL) can minimize surgical trauma to the largest degree. However, its implants have relatively poor stability; therefore, functional exercise cannot be performed in the early stages after surgery, which is inconducive to knee function recovery. It is extremely challenging to perform traditional open reduction with internal fixation to repair avulsion fractures at the tibial insertion of the knee PCL. Often, the crushed bones cannot be firmly fixed because of their small size, leading to a poor repair effect. Therefore, we designed a new inverted “L”-shaped incision in the popliteal fossa through which bone plates were inserted to fix the crushed bones and to reconstruct PCL tension, facilitating knee function recovery. In this study, we plan to compare the therapeutic effects of this new fixation and reconstruction method, and arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee PCL.
Design:
A prospective, single-center, non-randomized controlled trial.
Methods:
One hundred and eighty patients (knees) with avulsion fracture at the tibial insertion of the knee PCL will be assigned to two groups based on treatment methods: arthroscopic reconstruction group (
n
= 90; fracture fixation and repair under the arthroscope) and new method group (
n
= 90; bone plates will be inserted through an “L”-shaped incision in the popliteal fossa to fix the crushed bones and reconstruct PCL tension). After surgery, these patients will be followed up for 6 weeks, 6 months, and 12 months.
Outcome measures and preliminary results:
The primary outcome measure is the excellent and good rate of knee function recovery at 12 months after surgery as evaluated by Lysholm Knee Scoring Scale score (herein referred to as Lysholm score). The secondary outcome measures are the excellent and good rate of knee function recovery before surgery, 6 weeks and 6 months after surgery; Lysholm score before surgery, 6 weeks, 6 months and 12 months after surgery; Hospital for Special Surgery (HSS) knee score, Visual Analogue Scale (VAS) score, posterior drawer test negative rate, X-ray morphology of the knee before surgery, and 6 weeks, 6 months, and 12 months after surgery and; incidence of adverse events at 6 weeks, 6 months and 12 months after surgery. Results of a preliminary study involving 62 patients (knees) with avulsion fracture at the tibial insertion of the knee PCL showed that posterior drawer test negative rate and Lysholm score were significantly higher in the new method group compared to the arthroscopic reconstruction group (
P
< 0.05) at 3 months after surgery.
Discussion:
This study will be performed to compare the therapeutic effects of bone plate insertion through an “L”-shaped incision made in the popliteal fossa to fix the crushed bones and to reconstruct PCL tension, and traditional fracture fixation and repair under the arthroscope to treat avulsion fracture at the tibial insertion of the knee PCL. We believe that the former method will be superior to the latter one because it can fix the avulsion fracture more firmly, facilitating knee function recovery.
Ethics and dissemination:
This study has been approved by Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). This study will be performed in strict accordance with the
Declaration of Helsinki
formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in April 2018. Patient recruitment will end in June 2019. Data analysis will be performed in August 2020. The study will be completed in October 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.
Trial registration:
This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800015026). Protocol version: 1.0.
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Hemostasis following local
versus
intravenous tranexamic acid in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures: study protocol for a parallel-group, randomized controlled trial
Jun Sheng, Da Liu, Ying Chen, Xi-Lin Liu, Hong-Hua Wu, Wei Zheng
October-December 2018, 3(4):113-119
DOI
:10.4103/2542-4157.248609
Background and objectives:
Local bleeding is relatively frequent during and after posterior open reduction and internal fixation of thoracolumbar fractures, with associated health risks. Both local and intravenous tranexamic acid have been shown to effectively reduce intraoperative blood loss, but the optimal method for achieving intraoperative hemostasis remains unclear. This study aims to compare hemostasis following local and intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures.
Design:
A prospective, single-center, parallel-group, randomized controlled trial.
Methods:
This trial is conducted in 150 patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures at the Department of Orthopedics, the General Hospital of Western Theater Command, China. The included patients are divided randomly and evenly into three groups (
n
= 50 per group). Patients in the intravenous administration group receive 100 mg/kg tranexamic acid dissolved in 100 mL normal saline intravenously 15 minutes before surgery; in the local administration group, the wound is flushed with a mixture of 10 mg/kg tranexamic acid and 50 mL normal saline before wound closure. Excess fluid is removed 10 minutes later using an aspirator and the wound is closed. Patients in the control group receive intravenous and local administration of normal saline. All patients are followed up at 1, 3, and 5 days after surgery.
Outcome measures:
The primary outcome measure is intraoperative blood loss, as a measure of intraoperative hemostasis. The secondary outcome measures are intraoperative blood transfusion, amount of drainage at postoperative days 1, 3, and 5, hemoglobin level, D-dimer level, international normalized ratio, prothrombin time, and activated partial thromboplastin time before surgery and at postoperative days 1, 3, and 5.
Disscusion:
This study compares hemostasis following local
versus
intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures, to determine the optimal intraoperative hemostasis program for reducing surgical risk.
Ethics and dissemination:
This study has been approved by the Medical Ethics Committee of the General Hospital of Western Theater Command, China (approval No. 2015-keyan-03). The version of study protocol is 1.3. Patients and their family members should participate in this study voluntarily and written informed consent should be obtained from each patient. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.
Trial registration:
This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-ICR-15006037) on January 26, 2015.
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881
Efficacy and safety of a digital navigation template combined with cervical pedicle screw implantation: study protocol for a prospective, single-center, self-controlled, clinical trial
Wei Wei, Long-yan Xing, Jia-xun Jiao, Lei Zhao, Ai-qing Lu
October-December 2017, 2(4):138-143
DOI
:10.4103/2542-4157.219374
Background and objectives:
Cervical pedicle screw fixation is a reliable method for the treatment of traumatic and non-traumatic cervical instability and cervical disc removal and fixation; however, the operation risks and the failure rate of screw insertion are still high. At present, the digital navigation template with digital computer technology, used in the department of orthopedics, has the advantages of accurate screw insertion and a small error in the screw insertion depth. This trial aims to observe the clinical efficacy and safety of the digital navigation template combined with cervical pedicle screw implantation.
Design:
This is a prospective, single-center, self-controlled, clinical trial.
Methods:
Thirty-two patients with cervical spondylosis will be recruited from the Harrison International Peace Hospital, Hebei Province, China. Before surgery, a three-dimensional (3D) navigation model of the cervical vertebrae will be designed by 3D reconstruction. The navigation template will be generated by 3D printing. The cervical pedicle screws will be implanted according to preoperatively designed models and the screw positions will be observed by computerized tomography (CT) after surgery. The patients will be followed up for 40 months.
Outcome measures:
The primary outcome measure is the excellent and good rate of screw position 40 months after implantation. The secondary outcome measures include the Visual Analog Scale score, American Spinal Injury Association classification, cervical X-ray and CT images before implantation and 40 months after implantation, and the incidence of adverse reactions 40 months after implantation.
Discussion:
We will verify a high success rate of cervical pedicle screw implantation using the digital navigation template. The operation is simple and quick, with good efficacy and safety.
Ethics and dissemination:
The protocols have been approved by the Ethics Committee of the Harrison International Peace Hospital in China (approval number: 20120630). The study protocol has been conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. The recruitment of subjects will begin in December 2017. Samples and data will be collected from December 2017 to April 2019. Outcome measures will be analyzed in October 2020. This trial will be completed in November 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal.
Trial registration:
This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013481).
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Online since 30
th
November, 2015