Pub Date : 2019-07-01DOI: 10.4103/2542-4157.265975
P. Mahadevappa, Supreeth Nekkanti, Punith Nanjesh, Alok Moogali, Sachin Patel
Background and objective: Osteoporosis is a common orthopaedic problem of the geriatric population. Bisphosphonates have been effectively used to control osteoporosis and improve the bone strength. Bisphosphonates has particularly been used in glucocorticoid induced osteoporosis. However, there are emerging concerns over the risk of atypical femoral pathological fractures consequent to prolonged use of BPN therapy. This study was designed to report the diagnosis and treatment of atypical subtrochanteric femur fractures after bisphosphonate treatment. Subject and methods: We report a rare case of atypical femur fracture in a 70-year-old female patient who has been taking bisphosphonates for glucocorticoid-induced osteoporosis for 5 years. She suffered a subtrochanteric fracture after tripping on the doorstep. The fracture was fixed using a titanium proximal femur nail. The patient was followed up by X-ray examination 1 year after operation. This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Jagadguru Sri Shivarathreeshwara Hospital, India. Written informed consent was obtained from the patient. Results: The postoperative period was uneventful, and the patient recovered well. The patient was independently ambulatory with good function of her left hip. Conclusion: Atypical femoral fractures are defined clearly by the American Society of Bone and Mineral Research (ASBMR) criteria. Many reports in the literature have reported atypical femoral fractures after bisphosphonates therapy but do not meet the ASBMR criteria. The risk ratio of atypical femoral fractures after bisphosphonates use is high. Regular monitoring and screening of patients on bisphosphonates therapy by radiographs allow us to diagnose these fractures early and treat them successfully.
背景与目的:骨质疏松症是老年人群常见的骨科问题。双膦酸盐已被有效地用于控制骨质疏松症和提高骨强度。双膦酸盐特别用于糖皮质激素引起的骨质疏松症。然而，对于长期使用BPN治疗导致的非典型股骨病理性骨折风险的担忧正在出现。本研究旨在报道双膦酸盐治疗后非典型股骨粗隆下骨折的诊断和治疗。研究对象和方法:我们报告一例罕见的非典型股骨骨折病例，患者为70岁女性，因糖皮质激素所致骨质疏松症服用双膦酸盐治疗5年。她在门阶上绊倒，导致转子下骨折。骨折采用钛股骨近端钉固定。术后1年随访x线检查。这项研究是根据《赫尔辛基宣言》进行的，并得到印度Jagadguru Sri Shivarathreeshwara医院机构审查委员会的批准。获得患者的书面知情同意。结果:术后顺利，患者恢复良好。患者可独立行走，左髋关节功能良好。结论:美国骨与矿物研究协会(ASBMR)的标准明确定义了非典型股骨骨折。许多文献报道了双膦酸盐治疗后的非典型股骨骨折，但不符合ASBMR标准。使用双膦酸盐后发生非典型股骨骨折的风险比很高。通过x线片对接受双膦酸盐治疗的患者进行定期监测和筛查，使我们能够及早诊断并成功治疗这些骨折。
{"title":"Atypical subtrochanteric femur fracture following bisphosphonates: A grey area of diagnosis and management","authors":"P. Mahadevappa, Supreeth Nekkanti, Punith Nanjesh, Alok Moogali, Sachin Patel","doi":"10.4103/2542-4157.265975","DOIUrl":"https://doi.org/10.4103/2542-4157.265975","url":null,"abstract":"Background and objective: Osteoporosis is a common orthopaedic problem of the geriatric population. Bisphosphonates have been effectively used to control osteoporosis and improve the bone strength. Bisphosphonates has particularly been used in glucocorticoid induced osteoporosis. However, there are emerging concerns over the risk of atypical femoral pathological fractures consequent to prolonged use of BPN therapy. This study was designed to report the diagnosis and treatment of atypical subtrochanteric femur fractures after bisphosphonate treatment. Subject and methods: We report a rare case of atypical femur fracture in a 70-year-old female patient who has been taking bisphosphonates for glucocorticoid-induced osteoporosis for 5 years. She suffered a subtrochanteric fracture after tripping on the doorstep. The fracture was fixed using a titanium proximal femur nail. The patient was followed up by X-ray examination 1 year after operation. This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Jagadguru Sri Shivarathreeshwara Hospital, India. Written informed consent was obtained from the patient. Results: The postoperative period was uneventful, and the patient recovered well. The patient was independently ambulatory with good function of her left hip. Conclusion: Atypical femoral fractures are defined clearly by the American Society of Bone and Mineral Research (ASBMR) criteria. Many reports in the literature have reported atypical femoral fractures after bisphosphonates therapy but do not meet the ASBMR criteria. The risk ratio of atypical femoral fractures after bisphosphonates use is high. Regular monitoring and screening of patients on bisphosphonates therapy by radiographs allow us to diagnose these fractures early and treat them successfully.","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125447410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-01DOI: 10.4103/2542-4157.259629
Sukrit Sharma, S. Goel, Sunil Sharma, H. Chhabra
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.
{"title":"Polyetheretherketone cages used in anterior cervical discectomy and fusion surgery: a meta-analysis","authors":"Sukrit Sharma, S. Goel, Sunil Sharma, H. Chhabra","doi":"10.4103/2542-4157.259629","DOIUrl":"https://doi.org/10.4103/2542-4157.259629","url":null,"abstract":"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.","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121608762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-04-01DOI: 10.4103/2542-4157.259630
Xiao-guang Yang, Ying-Zhen Wang
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).
{"title":"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","authors":"Xiao-guang Yang, Ying-Zhen Wang","doi":"10.4103/2542-4157.259630","DOIUrl":"https://doi.org/10.4103/2542-4157.259630","url":null,"abstract":"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).","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128932407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 1900-01-01DOI: 10.4103/2542-4157.253723
Zhixing Xue, Jian-wei Zhou, Cheng Chi, Fei Wang, Yuquan Ma
Background and objective: Lumbar interbody fusion is the main surgical repair method for lumbar degenerative diseases. The best material for interbody fusion is autologous ilium, but its use is limited because of limited sources. Furthermore, autologous ilium implantation leads to the formation of osteophytes, which negatively affect bone healing. Inorganic osteogenesis-inducing scaffold material exhibits good biocompatibility and bone-inducing effects in posterior lumbar interbody fusion, with encouraging short-term outcomes. The present study will investigate the safety and long-term effects of inorganic osteogenesis-inducing scaffold materials versus autologous ilium in lumbar interbody fusion. Subjects and methods: This prospective, single-center, non-randomized, controlled trial will include 120 patients who receive treatment for lumbar degenerative diseases at the Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, China. These patients will receive lumbar repair surgery with inorganic osteogenesis-inducing scaffold materials (test group, n = 60) or autologous ilium (control group, n = 60). All patients will be followed up at 1 week, and 1 and 2 years postoperatively. This study was approved by the Medical Ethics Committee, Beijing Tongren Hospital, Capital Medical University, China (approval No. TRECKY2017-158) on September 28, 2017. Study protocol version: 1.0. All participants will provide written informed consent after fully understanding the study protocol. Results: The primary outcome measure of this study is the Oswestry Disability Index at 2 years postoperatively. The secondary outcome measures are the Oswestry Disability Index preoperatively and at 1 week and 1 year postoperatively, the Visual Analog Scale score, Japanese Orthopedic Association score, and lumbosacral angle preoperatively and at 1 week, and 1 and 2 years postoperatively, and the incidence of adverse reactions at 1 week, and 1 and 2 years postoperatively. A pilot study involving 52 patients with lumbar degenerative diseases treated during 2016–2017 revealed no significant differences between the test (n = 32, 61%) and control groups (n = 20, 39%) in the Oswestry Disability Index, Visual Analog Scale score, and Japanese Orthopedic Association score at 1 week postoperatively; at 12 months postoperatively, plain radiography revealed bony fusion in both groups. Conclusion: This study will provide evidence to validate whether inorganic osteogenesis-inducing scaffold material results in similar long-term outcomes to autologous ilium in lumbar interbody fusion. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1900021333) on February 15, 2019.
{"title":"Long-term effects of inorganic osteogenesis-inducing scaffold versus autologous bone in lumbar interbody fusion: protocol for a non-randomized, controlled trial","authors":"Zhixing Xue, Jian-wei Zhou, Cheng Chi, Fei Wang, Yuquan Ma","doi":"10.4103/2542-4157.253723","DOIUrl":"https://doi.org/10.4103/2542-4157.253723","url":null,"abstract":"Background and objective: Lumbar interbody fusion is the main surgical repair method for lumbar degenerative diseases. The best material for interbody fusion is autologous ilium, but its use is limited because of limited sources. Furthermore, autologous ilium implantation leads to the formation of osteophytes, which negatively affect bone healing. Inorganic osteogenesis-inducing scaffold material exhibits good biocompatibility and bone-inducing effects in posterior lumbar interbody fusion, with encouraging short-term outcomes. The present study will investigate the safety and long-term effects of inorganic osteogenesis-inducing scaffold materials versus autologous ilium in lumbar interbody fusion. Subjects and methods: This prospective, single-center, non-randomized, controlled trial will include 120 patients who receive treatment for lumbar degenerative diseases at the Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, China. These patients will receive lumbar repair surgery with inorganic osteogenesis-inducing scaffold materials (test group, n = 60) or autologous ilium (control group, n = 60). All patients will be followed up at 1 week, and 1 and 2 years postoperatively. This study was approved by the Medical Ethics Committee, Beijing Tongren Hospital, Capital Medical University, China (approval No. TRECKY2017-158) on September 28, 2017. Study protocol version: 1.0. All participants will provide written informed consent after fully understanding the study protocol. Results: The primary outcome measure of this study is the Oswestry Disability Index at 2 years postoperatively. The secondary outcome measures are the Oswestry Disability Index preoperatively and at 1 week and 1 year postoperatively, the Visual Analog Scale score, Japanese Orthopedic Association score, and lumbosacral angle preoperatively and at 1 week, and 1 and 2 years postoperatively, and the incidence of adverse reactions at 1 week, and 1 and 2 years postoperatively. A pilot study involving 52 patients with lumbar degenerative diseases treated during 2016–2017 revealed no significant differences between the test (n = 32, 61%) and control groups (n = 20, 39%) in the Oswestry Disability Index, Visual Analog Scale score, and Japanese Orthopedic Association score at 1 week postoperatively; at 12 months postoperatively, plain radiography revealed bony fusion in both groups. Conclusion: This study will provide evidence to validate whether inorganic osteogenesis-inducing scaffold material results in similar long-term outcomes to autologous ilium in lumbar interbody fusion. Trial registration: This study was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1900021333) on February 15, 2019.","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125035111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 1900-01-01DOI: 10.4103/2542-4157.253725
Jun Sheng, Dong-fa Liao, D. Liu, Y. Chen, Kai Jiang, Wei Zheng
{"title":"Effects of intravenous tranexamic acid on bleeding during and after pelvic fracture surgery: protocol for a prospective, randomized, parallel-controlled tria","authors":"Jun Sheng, Dong-fa Liao, D. Liu, Y. Chen, Kai Jiang, Wei Zheng","doi":"10.4103/2542-4157.253725","DOIUrl":"https://doi.org/10.4103/2542-4157.253725","url":null,"abstract":"","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114250586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 1900-01-01DOI: 10.4103/2542-4157.253724
J. Zhang, Shixuan Xiong, X. Tian, Fangning Gao, Chao-Chih Lin, Li-xue Yang
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). 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 sub
{"title":"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","authors":"J. Zhang, Shixuan Xiong, X. Tian, Fangning Gao, Chao-Chih Lin, Li-xue Yang","doi":"10.4103/2542-4157.253724","DOIUrl":"https://doi.org/10.4103/2542-4157.253724","url":null,"abstract":"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). 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 sub","PeriodicalId":348394,"journal":{"name":"Clinical Trials in Orthopedic Disorders","volume":"78 7 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128099415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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