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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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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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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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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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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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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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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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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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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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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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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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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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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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 L₅/S₁ 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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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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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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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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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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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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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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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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Background: Intravenous injection or topical application of tranexamic acid during total hip arthroplasty has been shown to effectively reduce blood loss. There is no consensus on differences in clinical efficacy and safety between these two administration methods. To determine the optimal clinical efficacy of tranexamic acid during hip replacement, we will compare differences between these two administration methods during total hip arthroplasty. Methods/Design: The study protocol is a prospective, paired (1:1:1), double-blind, randomized controlled clinical trial. A total of 174 patients who will receive hip replacement at Ruijin Hospital, Shanghai Jiao Tong University, China will be randomly divided into three groups, with 58 patients per group. Before the end of surgery, in the placebo group, 60 mL of physiological saline will be used to soak the articular cavity for at least 3 minutes and then be sucked away; in the topical tranexamic acid group, 60 mL of physiological saline containing 3 g tranexamic acid will be used and then sucked away; in the intravenous tranexamic acid group, 100 mL of physiological saline containing 10 mg/kg tranexamic acid will be intravenously administered 15 minutes before surgery and then again 3 hours later. The primary outcome is total blood loss on postoperative day 3, which is calculated using Nadler's and Gross's formula. Secondary outcomes include blood transfusion rates, drainage output within 2 days postoperation, amount of human serum albumin used during hospitalization, postoperative blood coagulation indices, and incidences of deep venous thrombosis and other thromboembolic events during postoperative day 1-week 6. Discussion: This protocol is powered to provide reference information for the rational use of tranexamic acid by comparing clinical efficacy of the drug between intravenous and topical administration routes. Trial registration: ClinicalTrials.gov identifier: NCT02312440; registered on 28 November 2014. Ethical approval: This study protocol was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University, China (permission No. (2014)-47-2) and will be performed in accordance with the Declaration of Helsinki.

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Background: Surgical adhesive drapes can be used to create an aseptic area around the operative wound to reduce bacterial infection. However, the efficacy of such drapes in preventing wound infection remains unclear. Few studies have examined the effects of iodophor-impregnated and iodophor-free adhesive drapes on bacteria in the deeper layers of the epidermis. We therefore plan to compare the effects of 3M iodophor-impregnated antibacterial adhesive drapes and 3M aseptic iodophor-free adhesive drapes on the incidence of wound infection and wound healing after total hip arthroplasty. Methods/Design: We will perform a single-center, randomized, double-blinded, parallel-cohort controlled trial at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. A total of 120 patients scheduled for total hip arthroplasty will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be operated on using iodophor-impregnated adhesive drapes, and even-numbered with iodophor-free adhesive drapes at the surgical site. Peri-articular tissue will be harvested for bacterial culture after disinfection and again between the end of surgery and prior to skin suturing. The primary outcomes will be Bacterial culture results, wound healing time and grade, The secondary outcomes will be pain score (Visual Analog Scale), Harris score, and X-ray results. Discussion: The trial outcomes will support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty. Trial registration: ClinicalTrial.gov identifier: NCT02707302. Ethical approval: This study protocol acquired written approval from Ethics Committee of Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.

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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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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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