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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
1
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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22,352
1,825
4
STUDY PROTOCOL
Isometric muscle strength as a predictor of one repetition maximum in healthy adult females: a crossover trial
Manisha Parai, Pramod Divakara Shenoy, Shalini Velayutham, Choo Kian Seng, Charmaine Yip Fung Yee
April-June 2016, 1(2):71-78
DOI
:10.4103/2468-5674.183005
One repetition maximum (1RM) and maximum voluntary contraction (MVC) with a digital dynamometer are popular methods of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with a digital dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in measurement of 1RM, such as delayed onset muscle soreness and being unsafe for pathological joints, all of these can be reduced if we use IMMC in measuring muscular strength. Both cannot be equated as they are different types of contraction, therefore the purpose of this study was to compare and find a relationship between 1RM measurement and isometric MVC in healthy females. Twenty-nine young females (mean age = 20.77 ± 1.28 years) without any weight training experience (mean body mass index = 20.43 ± 1.85) volunteered to participate in the study. It was a crossover trial where 48 hours of rest period was given between each measurement technique. Results showed moderate correlations (
r
= 0.365-0.847) between 1RM and MVC. A simple linear regression analysis revealed a significant estimated regression equation for dominant and non-dominant sides [dominant,
Y
= 0.391
X
+ 1.472; non-dominant,
Y
= 0.251
X
+ 2.629 (
Y
: 1RM,
X
: Isometric)] with low standard error of estimate (dominant, 0.74; non-dominant, 0.80). Results also showed no significant difference between these derived equations and Brzycki 1RM prediction equation. Both prediction equations can be used interchangeably to predict the muscle strength of a healthy female, and thus IMMC can be used to predict 1RM in healthy females.
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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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1,457
4
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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1
ORIGINAL ARTICLES
Traction apophysitis of the medial malleolus
Sandeep Kumar Nema, Gopisankar Balaji, P Pasupathy, N Ravi
July-September 2016, 1(3):123-125
DOI
:10.4103/2468-5674.189517
Traction apophysitis of the accessory ossification center of the medial malleolus is infrequently reported. Traction apophysitis of both the accessory ossification centers of medial malleoli is very rare. This entity is also reported as osteochondrosis of medial malleolus in literature. We present a case of traction apophysitis of accessory ossification centers of both the medial malleoli in an 11-year-old boy of Indian origin, who presented with pain and swelling over both the ankle with plano-valgus deformity of feet. His imaging revealed fragmented accessory ossification center of medial malleoli on both the sides. He was treated non-operatively and followed through one year to see the eventual fate.
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STUDY PROTOCOL
Safety and efficacy of WeChat combined with
Yi Jin Jing
exercise for the treatment of cervical spondylosis in white-collar workers: study protocol for a prospective open label randomized controlled trial
Guang-hui An, Xiao-ting Tang, Guo-miao Zhu
January-March 2016, 1(1):31-37
DOI
:10.4103/2468-5674.178853
Background:
Yi Jin Jing
(changing tendon exercise) is a traditional Chinese exercise.
Yi Jin Jing
can reportedly prevent cervical spondylosis in financial professionals. In the absence of effective supervision and follow-up training,
Yi Jin Jing
self-exercise does not become habitual, reducing the efficacy of the technique. WeChat is an online text and voice messaging communication service developed by Tencent in China, and can be used as an interactive platform for doctors and patients. We hypothesized that WeChat could be used to guide
Yi Jin Jing
exercise, potentially enhancing the preventative and therapeutic benefits for cervical spondylosis in white-collar workers.
Methods/Design:
120 financial professionals with cervical spondylosis working at the Bank Card Industrial Park in Pudong New Area, Shanghai, China will be enrolled in this prospective, open label, randomized controlled trial. Participants will be equally and randomly divided into two groups. In the intervention group, participants will undertake conventional
Yi Jin Jing
training followed by a group chat using WeChat to provide interactive guidance. In the control group, participants will undertake conventional
Yi Jin Jing
training alone. The primary ontcome will be the Cervical Spondylosis Symptoms scale measured 1, 3, 6 and 12 months after training. The secondary outcomes will be the 36-item Short Form Health Survey score, Visual Analog Scale score for pain intensity, medical expenses and the number of days absent from work.
Discussion:
This study will examine whether on-going interactive
Yi Jin Jing
exercise using the WeChat platform will improve outcomes in participants with cervical spondylosis.
Trial registration:
This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-OCH-13003426) on 6 August 2013.
Ethical approval:
Written approval for this project was obtained from the Ethics Committee of Wanggang Community Health Center, Shanghai Pudong New Area, Shanghai, China (approval number WG2013 0709001). All patients will be informed of the protocols and will provide written informed consent.
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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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1,143
1
RESEARCH ARTICLES
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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14,369
1,350
1
Effect of tourniquet use during total knee arthroplasty on global inflammatory cytokine changes associated with ischemia- reperfusion injury
Brian Wu, Ryan Graff, Ido Badash, Joseph G Skeate, Christianne Lane, Ibrahim Mansour, Ravi Rao, Anthony Yi, Jarrad Merriman, C Thomas Vangsness, George Rick Hatch III, Larry Dorr, Paul Gilbert, E Todd Schroeder
January-March 2017, 2(1):1-10
DOI
:10.4103/2542-4157.201056
The use of tourniquets during total knee arthroplasties has been debated given the possibility that prolonged application of a tourniquet may result in ischemia-reperfusion injury, potentially contributing to post-operative muscle atrophy. The goal of this study is to elucidate the influence that tourniquet use may have on the induction of ischemia-reperfusion injury in muscle tissue following total knee arthroplasties surgeries. We hypothesize that prolonged operative use of a tourniquet will cause global increases in pro-inflammatory cytokines indicating the occurrence of ischemia-reperfusion injury, which may contribute to post-operative muscle atrophy. Fifty patients undergoing total knee arthroplasties surgeries were separated into three groups: no tourniquet (
n
= 17), operative tourniquet (
n
= 15), and tourniquet during implant cementation (
n
= 18). Induction of ischemia-reperfusion injury was evaluated by measuring changes in inflammatory cytokines in blood samples collected from an antecubital vein before and after surgery. Analysis suggests statistically significant differences in the concentrations of specific cytokines depending on variable tourniquet application. Overall, both pro-inflammatory and anti-inflammatory cytokines (including tumor necrosis factor-α, interleukin 1β, 4, 5, 12, and monocyte chemtactic protein-1) were found to increase upon application of tourniquets during cementation and decrease without tourniquet use or upon application of operative tourniquets. In general only slight changes in inflammatory cytokines occurred based on altered tourniquet use during total knee arthroplasties. Using global changes in inflammatory cytokine levels as an indicator of ischemia-reperfusion injury, these data may suggest that the use of a tourniquet does not significantly contribute to induction of ischemia-reperfusion injury in total knee arthroplasty surgeries. However, additional studies comparing local plasma cytokine changes near the tourniquet site and utilizing larger sample sizes are necessary to determine if tourniquets can be used in total knee arthroplasty without inducing ischemia-reperfusion injury.
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13,934
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1
Efficacy and safety of proximal femoral anatomical locking compression plate and proximal femoral nail antirotation for long-segment comminuted subtrochanteric fractures of the femur: a non-randomized controlled trial
Jie-Rong Zhang, Shi-Xi Xiong, Xiao-Lin Tian, Fang-Mao Gao, Chao Lin, Li-Xue Yang
January-March 2019, 4(1):8-16
DOI
:10.4103/2542-4157.253724
Background and objective:
The proximal femoral anatomical locking compression plate and proximal femoral nail antirotation device are commonly used in the treatment of long-segment comminuted subtrochanteric fractures of the femur. However, few studies have evaluated the difference in efficacy and safety between these two implants. The present study is being performed to compare the efficacy and safety of the proximal femoral anatomical locking compression plate
versus
proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur. The results will be used to identify the optimal implant treatment plan.
Participants and methods:
This prospective, single-center, non-randomized controlled clinical trial will include 180 patients with long-segment comminuted subtrochanteric fractures of the femur from Sanya Traditional Chinese Medicine Hospital, China. The patients will be equally divided into a locking compression plate group and a proximal femoral nail antirotation group. All patients will be followed up at 2 and 10 months postoperatively. Patient recruitment and data collection will begin on June 30, 2019 and end on June 30, 2020. Analysis of the results will be performed from 1 to 30 July 2020. This study will be scheduled to end on August 1, 2022. This study was approved by the Medical Ethics Committee of Sanya Traditional Chinese Medicine Hospital in China in March 2013 (approval No. (2013) (02)). Study protocol version is 1.0. 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 the participants.
Results:
The primary outcome measure is the rate of excellent and good Harris hip scores at 10 months postoperatively; this rate will be used to evaluate the recovery of hip function after repair. The secondary outcome measures are the rate of excellent and good Harris hip scores preoperatively and 2 months postoperatively, intraoperative blood loss, operation time, incision length, hospital stay, fracture healing time, hip morphology on radiographs preoperatively and 2 months postoperatively, and incidence of adverse events 2 and 10 months postoperatively. Our pilot study involved 80 patients with long-segment comminuted subtrochanteric fractures of the femur from February 2013 to February 2016 (locking compression plate group,
n
= 40; proximal femoral nail antirotation group,
n
= 40). The 10-month follow-up results showed that the intraoperative blood loss, operation time, incision length, hospital stay, and fracture healing time were lower in the proximal femoral nail antirotation group than in the locking compression plate group (
P
< 0.05). The rate of an excellent and good Harris hip score was higher in the proximal femoral nail antirotation group than in the locking compression plate group (
P
< 0.05). The complication rate was lower in the proximal femoral nail antirotation group (10.0%) than in the locking compression plate group (12.5%) (
P
> 0.05). These pilot study results verified higher efficacy and safety of proximal femoral nail antirotation than locking compression plate fixation in the treatment of long-segment comminuted subtrochanteric fractures of the femur.
Conclusion:
The results of the present study will provide evidence indicating whether proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur can facilitate better recovery of hip function and higher safety than anatomical locking compression plate fixation.
Trial registration:
This study was registered with the Chinese Clinical Trial Registry on February 3, 2019 (registration number: ChiCTR1900021251).
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956
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ORIGINAL ARTICLES
How well do lower femoral neck shaft angled stems match patients with coxa vara hip deformities?
Omar Alnachoukati, Roger Emerson, Kwame Ennin, Alex Vidal
July-September 2017, 2(3):91-96
DOI
:10.4103/2542-4157.213686
Background and objectives:
Patients undergoing total hip arthroplasty (THA) may have femoral deformities classified as either coxa vara, coxa valga, or physiologic. Understanding patients' anatomies is of importance for surgeons in an effort to tailor not only surgical approach, but also implant selection, and ultimately ensure optimal outcomes. The goal of the present study is to determine the efficacy of implanting a lower neck shaft angle (NSA) femoral stem in patients with coxa vara deformities and determine short-term clinical outcomes.
Design:
A retrospective chart review study.
Methods:
The study took place at The Texas Center for Joint Replacement in Plano, Texas. Two patient groups, clinical outcomes group and EOS group, were used for this study. The clinical outcomes group contained 55 patients who had undergone primary THA surgery from June 2013 to June 2015 by the senior author. The EOS group contained 36 patients who had undergone primary THA, and completed both preoperative and postoperative biplanar X-rays (low dose imaging device EOS) to obtain three-dimensional reconstructions of the skeletal system from October 2015 to November 2016. Operations were performed in all hips through the anterior supine intermuscular approach utilizing a 123° NSA femoral stem, which was lower than the NSA (133°) found in standard femoral stem implants.
Outcome measures:
Pre- and postoperative Harris hip scores used to assess clinical outcomes following surgery. Pre- and postoperative femoral offset, NSA, and femur length determined by EOS.
Results:
In the EOS group, mean femoral offset decreased by 3.5 mm, from 41.08 mm preoperatively to 37.6 mm postoperatively. Mean femoral NSAs decreased by 0.02°, from 123.02° preoperatively to 123.00° postoperatively. Mean femur length decreased by 2.4mm, from 404.2 mm preoperatively to 401.8 mm postoperatively. In the clinical outcomes group, mean Harris hip scores rose from 47 preoperatively to 93 postoperatively. Hip flexion range of motion improved from 87.5° preoperatively to 98° postoperatively.
Conclusion:
The lower NSA femoral stem examined in this study was proven to accurately restore NSA by 0.03°, femoral offset by 3.47 mm, and femur length by 2 mm, all within clinically documented satisfactory ranges without no revisions, suggesting excellent clinical outcomes in patients with coxa vara hip deformities. THA surgeons may consider utilizing femoral stems with a lower NSA in an effort to adequately restore hip function in patients with coxa vara hip deformities.
Trial registration:
This is a retrospective chart review study, therefore registration was not required.
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13,484
896
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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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13,195
1,115
2
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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5
Ultrasound-guided supine lumbar plexus block
versus
iliac fascia block for analgesia in older adult patients undergoing hip replacement: a randomized controlled trial
Xiao-Long Lu, Xue-Feng Yu, Si-Mao Hu, Xue-Lei Zheng, Qiong Li, Yong Liu, Pan-Ru Wang, Jian-Min Peng, Bin Mei
October-December 2018, 3(4):81-88
DOI
:10.4103/2542-4157.248573
Background and objectives:
Anesthesia is an important part of hip replacement in older adult patients. Lumbar plexus block and iliac fascia block are common block methods in hip replacement. This study will compare the analgesic effects of ultrasound-guided supine lumbar plexus block and multi-angle multi-point iliac fascia block during hip replacement in older adult patients. The result will identify the optimal analgesic regimen.
Methods:
This prospective, single-center (Lu’an Civily Hospital in China), randomized controlled trial will include 208 older adult patients who are scheduled to undergo hip replacement. The patients will be randomly assigned to one of two groups (
n
= 104/group). In the lumbar plexus-block group, patients will undergo supine lumbar plexus block, general anesthesia using a laryngeal mask airway, and subsequent hip replacement. In the iliac fascia-block group, patients will undergo multi-angle multi-point iliac fascia block, general anesthesia using a laryngeal mask airway, and subsequent hip replacement. After surgery, all patients will be followed up for 24 hours.
Results:
The primary outcome measure of this study is a Visual Analog Scale score obtained 24 hours post-surgery, which will be used to evaluate the postoperative analgesic effect. The secondary outcome measures are Visual Analog Scale scores at 2, 6 and 12 hours post-surgery, heart rate at various time points during the surgery (laryngeal mask placement, T0; surgical incision, T1; surgical reaming, T2; prosthesis implantation, T3; incision suture, T4; and resuscitation, T5), mean arterial pressure, blood oxygen saturation, intraoperative sufentanil, perdipine, and ephedrine dosages, total amount of intravenous patient-controlled analgesics at 2, 6, 12, and 24 hours post-surgery, and incidence of adverse reactions. Results of a pilot study involving 60 older adult patients who underwent hip replacement during March 2018 through September 2018 showed that intraoperative sufentanil, perdipine, and ephedrine dosages were significantly lower in the lumbar plexus-block group (
n
= 30) than in the iliac fascia-block group (
n
= 30;
P
< 0.05); heart rate at T2, T3, T4 and T5 was significantly lower in the lumbar plexus-block group than in the iliac fascia block group (
P
< 0.05); heart rate at T1, T2, T3, and T5 was significantly greater than that at T0 in the iliac fascia-block group (
P
< 0.05); mean arterial pressure at T1, T2, T3, T4 and T5 was significantly lower in the lumbar plexus-block group than that in the iliac fascia-block group (
P
< 0.05), and mean arterial pressure at T1, T2, T3, and T4 was significantly higher than that at T0 in the iliac fascia-block group (
P
< 0.05). Mean arterial pressure at T3 and T4 was significantly lower than that at T0 in the lumbar plexus-block group (
P
< 0.05). Visual Analog Scale scores at 6, 12, and 24 hours post-surgery were significantly higher in the iliac fascia-block group than in the lumbar plexus-block group (
P
< 0.05).
Conclusion:
Results from this study will provide evidence indicating whether ultrasound-guided supine lumbar plexus block in combination with general anesthesia can more effectively maintain stable hemodynamic indices during hip replacement and whether it results in more encouraging postoperative analgesic effects in older adult patients than multi-angle multi-point iliac fascia block.
Ethics and trial registration:
This study was approved by the Medical Ethics Committee of Lu’an Civily Hospital in March 2018 (approval No. PJ2018-001). The study protocol version is 1.0. Patients participating in this study will provide their written informed consent after fully understanding the study protocol. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019888).
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13,042
1,032
1
STUDY PROTOCOL
A corrective functional exercise program for postural thoracic kyphosis in teenagers: study protocol for a randomized, controlled clinical trial
Qiang Feng, Yu Zhou, Mei Wang, Yan-feng Zhang, Fubaihui Wang
October-December 2016, 1(4):158-163
DOI
:10.4103/2542-4157.194805
Background:
In this report, we describe our protocol for testing the hypothesis that a comprehensive corrective training program for teenagers could effectively treat postural thoracic kyphosis, which is a common problem in this age group.
Methods/Design:
This was a prospective, single-center, randomized, controlled, open-label trial completed at the China Institute of Sport Science in Beijing, China. Eighty teenagers were enrolled and randomized into two groups (
n
= 40/group). The participants completed one of two training programs: 1) a comprehensive training program aimed at functional correction of posture that targeted active range of motion, proprioception, and strength of the muscles acting on the cervical, thoracic, and lumbar vertebrae (test group) or 2) a standard strength-training program (control group). The two training programs were designed to be equal in intensity and each consisted of two 20-minute sessions per week for 8 consecutive weeks. All participants underwent non-invasive testing using Spinal Mouse® while standing upright, and with their trunks in flexion and extension, before, and at 1, 2, and 4 weeks after the final training session. Outcome measures were assessed before training and 1, 2, and 4 weeks after the last training session. The primary outcome was thoracic kyphosis angle. Secondary outcomes included lumbar lordosis, sacral inclination angle, thoracic inclination angle, range of motion of the spine, posture, and the incidence of adverse events.
Discussion:
Successful treatment of postural thoracic kyphosis would improve the health of affected teenagers.
Trial registration:
This trial was registered in the Chinese Clinical Trial Registry (
www.chictr.org.cn
) (registration number: ChiCTR-INR-16008860).
Ethics:
This trial has been approved by the Ethics Committee of the China Institute of Sport Science, Beijing, China and performed in accordance with the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Training content and process was fully exposed to all the participants, and signed informed consent was obtained from each participant.
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12,847
1,152
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Safety and effectiveness of proximal femoral nail antirotation for the treatment of intertrochanteric femoral fracture: study protocol for a prospective case series
Jun-jie Xu
July-September 2016, 1(3):90-99
DOI
:10.4103/2468-5674.189505
Background:
The root cause of intertrochanteric femoral fracture in elderly patients is osteoporosis manifested by reduced bone strength, decreased bone mineral density, and subsequently decreased anchoring between the internal fixator and bone. This is also a major cause of ineffective internal fixation and leads to surgical failure. Because of the special anatomical structure and biomechanical requirements of the proximal femur, internal fixation must have two basic functions, to prevent inversion and rotation of the proximal fractured femur. Reducing the incidence of coxa vara is also one of the treatment objectives.
Methods/Design:
This is a single-center, prospective, self-controlled case series. The objective of this study is to validate the safety and effectiveness of minimally invasive proximal femoral nail antirotation (PFNA) in the treatment of intertrochanteric femoral fracture. Twenty patients with intertrochanteric femoral fracture scheduled to undergo PFNA implantation will be recruited from the Department of Orthopedics, Chaohu Hospital of Anhui Medical University, China. The primary outcome measure of this study is the percentage of patients having PFNA implantation-related safety problems manifested as pain in the affected region, wound nonunion, incisional infection, and gross findings observed at the time of nail removal, including inflammatory reaction, tissue proliferation, and the appearance of a fibrous capsule wall 3 and 6 months after PFNA implantation. The secondary outcome measures are operative time, intraoperative blood loss, duration of intraoperative fluoroscopy, patients' quality of life evaluated by the EuroQol five-dimension questionnaire and the Barthel Index of Activities of Daily Living, fracture healing examined by X-ray images, and hip joint function evaluated by Harris hip scores 3 and 6 months after PFNA implantation.
Discussion:
The currently reported clinical studies on PFNA for the treatment of intertrochanteric femoral fracture are mainly case series, a few of which are retrospective, randomized, controlled trials. Here, we will perform a normalized prospective case series to validate the safety and effectiveness of PFNA in the treatment of intertrochanteric femoral fracture.
Trial registration:
ClinicalTrial.gov identifier: NCT02880501; registered on 18 August 2016.
Ethics:
This trial has been approved by Ethics Committee, Chaohu Hospital of Anhui Medical University, China and will be performed in accordance with the
Declaration of Helsinki
, formulated by the World Medical Association.
Informed consent:
Signed informed consent will be obtained from the patients or their relatives.
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12,996
984
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RESEARCH ARTICLES
Efficacy of arthroscopic surgery for discoid lateral meniscus injury in knee joint: a self-control study
Jian-Jun Mai, Bin Xu, Jun Tu, Lei Wu
October-December 2018, 3(4):89-96
DOI
:10.4103/2542-4157.248605
Background and objectives:
Discoid meniscus injury is a rare form of abnormal meniscus morphology with unknown pathogenesis. The complete disc-shaped meniscus is more prone than incomplete disc-shaped meniscus to tearing and adverse reactions such as joint degeneration and osteochondritis. Moreover, its clinical efficacy is not satisfactory. Arthroscopic meniscus surgery can enhance the stability of the meniscus and provide sufficient cushioning pressure to prevent recurrent meniscal tears. Therefore, this study will investigate the efficacy of arthroscopic surgery for discoid meniscus injury in knee joint and analyze risk factors that influence the efficacy of arthroscopic surgery.
Methods:
This single-center, self-control study will include 196 patients with discoid meniscus injury who will receive arthroscopic meniscus repair (Stryker) from December 2018 to December 2019 at the Department of Sports Trauma and Arthroscopy, First Affiliated Hospital of Anhui Medical University of China. This surgical procedure will include meniscus plasty and subtotal meniscectomy. After surgery, all included patients will be followed up for 6–18 months. Surgical efficacy will be evaluated by Lysholm score. Patients will be divided into an excellent-and-good group (Lysholm score ≥ 85) and a poor group (Lysholm score < 85).
Results:
The primary outcome measure of this study is the change in excellent-and-good rate of Lysholm score that reflects knee joint function measured at the last follow-up in patients undergoing arthroscopic meniscus surgery. Secondary outcome measures are Lysholm score; Outerbridge grade of chondral lesion; knee joint morphology by magnetic resonance images before surgery and at the last follow-up; age, sex, lesion region, and course of disease before surgery; and incidence of adverse reactions at the last follow-up. Clinical data from 115 patients with discoid meniscus injury (150 knees) who received treatment from April 2015 to September 2016 were retrospectively analyzed. Six to eighteen months of follow-up of 115 patients revealed a significant difference in Lysholm scores before surgery (65.80 ± 9.39) and at the last follow-up (89.15 ± 7.45;
P
< 0.05). Postoperative Lysholm scores were excellent in 32 patients, good in 61 patients, fair in 18 patients, and poor in four patients, with an excellent-and-good rate of 80.9%. Knee joint infection did not occur in any patient. There were four patients with lateral interstitial pain and two patients with lateral instability of the knee joint. Logistic regression analysis revealed that course of disease, age, and Outerbridge grade of chondral lesion were risk factors that influenced the efficacy of arthroscopic meniscus surgery.
Conclusion:
Results from this study hope to confirm that arthroscopic surgery for discoid meniscus injury is a definitive treatment technique. Patient age and the degree of chondral lesion are closely related with efficacy, so it is recommended that patients with symptomatic discoid meniscus injury undergo surgery as soon as possible.
Ethics and trial registration:
This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Anhui Medical University (approval No. PJ2018-02-03) on February 5, 2018. The version of the study protocol is 1.0. Patients and their family members will volunteer to participate in this study. Written informed consent will be obtained from each patient. This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800019182) on October 30, 2018.
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12,917
898
1
STUDY PROTOCOL
Femoral nerve block prevents deep venous thrombosis of the lower extremity after knee arthroplasty: a single-center randomized controlled trial
Yi Chen, Shen Qu, Gang Ma, Jin-hai Meng, Xin-li Ni
January-March 2016, 1(1):8-14
DOI
:10.4103/2468-5674.178820
Background:
The use of tourniquets in knee arthroplasty can promote the release of abundant neutrophil elastase from neutrophils, which increases the risk of deep venous thrombosis of the lower extremity. Advanced femoral nerve blocks can decrease the risk of deep venous thrombosis of the lower extremity after knee arthroplasty, but their mechanism of action remains unclear. We assume that the femoral nerve block can effectively suppress the inflammatory reaction and prevent deep venous thrombosis of the lower extremity after knee arthroplasty.
Methods/Design:
A total of 120 patients undergoing total knee arthroplasty under general anesthesia in the General Hospital of Ningxia Medical University of China will be enrolled in this single-center randomized controlled trial. These patients will be equally and randomly assigned to three groups. In the advanced femoral nerve block group, ultrasound-guided femoral nerve block will be conducted 30 minutes before surgery. In the conventional femoral nerve block group, ultrasound-guided femoral nerve block will be carried out at consciousness after surgery. In the intravenous analgesia group, an analgesia pump will be used to relieve pain after surgery. The primary outcomes will be the changes in the levels of serum thrombosis-related inflammatory factors (neutrophil elastase, thrombin-antithrombin III complex, D-dimers, C-reactive protein, tumor necrosis factor-α, interleukin-1, interleukin-6, and interleukin-8) immediately after entering the operating room; 30 and 60 minutes after application of the tourniquet; 30 minutes after removal of the tourniquet; and 12, 24 and 48 hours after surgery. The secondary outcomes measures will be the Ramsay Sedation Scale score, visual analogue scale score, times until initial and complete effect of the block, muscle strength rating, blood loss, and color Doppler ultrasound examination results of the lower extremity veins.
Discussion:
We hope to identify the clinical advantages of advanced femoral nerve block for total knee arthroplasty and determine whether deep venous thrombosis of the lower extremity after knee arthroplasty can be prevented by inhibiting the release of abundant neutrophil elastase and suppressing the inflammatory reaction.
Trial registration:
ClinicalTrial.gov identifier: NCT02411097; registered on 20 March 2015.
Ethical approval:
Written approval for this project was obtained from the Ethics Committee of the General Hospital of Ningxia Medical University of China. All patients or their family members will be informed of the protocols and will provide written informed consent. Our study is in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
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12,680
1,060
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RESEARCH ARTICLES
Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial
Xiao-Guang Yang, Ying-Zhen Wang
April-June 2019, 4(2):34-40
DOI
:10.4103/2542-4157.259630
Background and objective:
Anterior cruciate ligament tibial eminence avulsion fractures are repaired
via
early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification. The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture.
Participants and methods:
This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is 1.0. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves.
Results:
The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and magnetic resonance images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (
P
< 0.05). Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores were significantly improved 6 months postoperatively compared with preoperatively (
P
< 0.05).
Conclusion:
This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture.
Trial registration:
This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865).
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12,610
888
-
STUDY PROTOCOL
Cubital tunnel syndrome treated with ulnar nerve simple decompression, anterior intramuscular or subcutaneous transposition: a parallel randomized controlled clinical trial
Qian-qian Liu, Rui Li
January-March 2016, 1(1):15-21
DOI
:10.4103/2468-5674.178845
Background:
Simple decompression and anterior transposition of the ulnar nerve are surgical methods commonly used for treating moderate and severe cubital tunnel syndrome. It is generally thought that anterior transposition effectively eliminates ulnar nerve compression, but simple decompression cannot improve symptoms. However, studies have also shown that the therapeutic effects of the two procedures are identical. The advantages and disadvantages of the two surgical methods have been described in a small number of cases. Thus, we will conduct a parallel-group randomized controlled clinical trial to determine the optimal surgical intervention.
Methods/Design:
The trial will be conducted at the Center for Hand and Foot Surgery and Reparative and Reconstructive Surgery, Orthopedics Hospital, the Second Hospital, Jilin University, China. Moderate and severe cubital tunnel syndrome patients will be equally and randomly divided into simple decompression, anterior intramuscular transposition, and anterior subcutaneous transposition groups. In the simple decompression group, adhesions will be completely removed around the ulnar nerve. In the anterior intramuscular transposition group, the ulnar nerve and its accompanying nutrient vessels will be removed in the tunnel of the forearm flexor, pronator teres muscle membrane, and a small portion of muscle fibers below it. In the anterior subcutaneous transposition group, the ulnar nerve in the cubital tunnel will be dissociated and placed in the subcutaneous tissue of the forearm flexor and pronator teres. Two primary outcomes will be determined, sensory disturbance, tested with Semmes-Weinstein filaments, and muscle strength, evaluated using the Medical Research Council's grading system. The secondary outcomes of pain will be assessed with the Visual Analogue Scale and the function of the ulnar nerve with electromyography.
Discussion:
Trial results will provide a reference for selecting an effective surgical method for treating moderate and severe cubital tunnel syndrome.
Trial registration:
ClinicalTrial.gov identifier: NCT01893164; registered on 2 July 2013.
Ethical approval:
Written approval for this project was obtained from the Ethics Committee of the Orthopedics Hospital, the Second Hospital, Jilin University of China. Our study is in accordance with the guidelines of the
Declaration of Helsinki
, formulated by the World Medical Association.
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12,501
978
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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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12,201
1,201
2
STUDY PROTOCOL
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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12,334
809
1
RESEARCH ARTICLE
Treating periodontal intrabony defects using guided tissue regeneration and Bio-Oss® with platelet-rich fibrin: study protocol for a self-controlled trial
Kai-Ning Liu, Zhen Huang, Zhi-Bin Chen, Bing Han, Xiang-Ying Ouyang
April-June 2020, 5(2):9-13
DOI
:10.4103/2542-4157.289237
Background and objective:
Guided tissue regeneration (GTR) has been widely used for periodontal regeneration after intrabony defects, and Bio-Oss
®
can be used together with GTR for the stability of the space under the GTR membrane. Platelet-rich fibrin (PRF), as a kind of platelet concentrate with rich autologous biologic agent, has been also used to treat periodontal intrabony defects for periodontal regeneration. However, whether PRF can enhance the regenerative effect of GTR and Bio-Oss
®
is not reported.
Subjects and methods:
This is a randomized self-controlled trial. Fourteen patients with periodontal intrabony defects who will receive treatment in the Department of Periodontology, Peking University School and Hospital of Stomatology, China will be included in this study. The left or right intrabony defects of each patient will be randomly randomized to a test group and a control group. In the test group, GTR, Bio-Oss
®
and PRF will be used for the treatment of periodontal intrabony defects. In the control group, GTR and Bio-Oss
®
will be used for the treatment of periodontal intrabony defects. PRF used in the trial will be liquid PRF, which can form Bio-Oss
®
-PRF mixture with Bio-Oss
®
, making the use of PRF easier in periodontal surgery. This study was approved by the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-201629066) on November 4, 2016.
Outcome measures:
The primary outcome is clinical attachment level, which will be measured at baseline, as well as 6, 12 and 24 months after surgery. The secondary outcomes include (1) depth of intrabony defect, (2) vertical bone loss, (3) probing depth, (4) bleeding index and (5) time of bone graft filling in the surgery. Radiographic evaluation will be accomplished at baseline and at 12 and 24 months after surgery. Probing depth and bleeding index assessments will be performed at baseline, and at 6, 12 and 24 months after surgery.
Discussion:
If the regenerative effects of GTR, Bio-Oss
®
, and PRF in combination are superior to those of GTR combined with Bio-Oss
®
, then the trial results will provide clinical evidence for the treatment of periodontal intrabony defects.
Trial registration:
Chinese Clinical Trial Registry, ID: ChiCTR1900027581. Registered on November 19, 2019.
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11,889
1,139
1
RESEARCH ARTICLES
Local anesthetic infiltration before open reduction and internal fixation for ankle fracture: a single-blind randomized controlled study
Juan Lopez-Valencia, Juan Jonathan De la Cruz-Pacheco, Joel Galindo-Avalos, Juan Manuel Gómez-Gómez, Alexis Rubén Álvarez-Narvaéz, Avelino Colín-Vázquez, Anapaola Koch-Leopo
October-December 2018, 3(4):97-100
DOI
:10.4103/2542-4157.248606
Background and objectives:
Ankle fractures are painful. Intense uncontrolled postoperative pain may lead to persistent pain and complications. Local anesthetic infiltration into a surgical wound or joint blocks the pain at its origin, and thus it is particularly well-suited for ambulatory surgery. Several studies have shown a clear correlation between increased local and regional anesthesia use and the success of major knee and shoulder procedures in an ambulatory setting. The preferred indication for local infiltration is foot and ankle surgery, as it allows for earlier ambulation and reduces the risk of falls when compared to more extensive blocks of the lower limp. The purpose of this study was to investigate the preoperative use effects of local infiltration of ropivacaine or bupivacaine in pain management after open reduction and internal fixation treatment for ankle fracture.
Methods:
In this prospective single-blind randomized controlled trial, 93 patients (42 women and 51 men) were randomly divided into ropivacaine (spinal anesthesia + local anesthetic infiltration with 37.5 mg of 0.75% ropivacaine), bupivacaine (spinal anesthesia + local anesthetic infiltration with 25 mg of 0.5% bupivacaine) and control (spinal anesthesia only) groups. All patients underwent open reduction and internal fixation for acute ankle fracture and local anesthetic infiltration was applied before incision. Pain was evaluated using Visual Analog Scale scores at 4, 8, 12, and 24 hours after surgery.
Results:
Local anesthesia with ropivacaine was better in pain management with a lower Visual Analog Scale score at 4 hours after surgery than local anesthesia with bupivacaine and spinal anesthesia (
P
< 0.05). At 8, 12 and 24 hours, local anesthesia with ropivacaine was slightly, but not significantly, better than local anesthesia with bupivacaine and spinal anesthesia (
P
> 0.05).
Conclusions:
Ropivacaine tends to have a rapider onset of action, longer acting effect, fewer complications, and lower motor block than bupivacaine in preoperative local anesthesia.
Ethics and trial registration:
This study protocol has been approved by the local ethics committee of IMSS in México (approval No. R-2016-3401-55) and was registered with ClnicalTrials.gov (Identifier: NCT02949674) on October 31, 2016.
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12,078
886
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