Journal of Orthopaedic Surgery and Research最新文献

{"title":"Characteristics of the femoral tunnel of anatomical and isometric single bundle anterior cruciate ligament reconstruction: a modeling analysis based on quadrant method and anatomical landmarks.","authors":"Li Yin, Dongfa Liao, Qingyun Xie, Jinbiao Liu, Bing Deng","doi":"10.1186/s13018-024-05306-6","DOIUrl":"10.1186/s13018-024-05306-6","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the anatomical features of the femoral tunnel in anatomical and isometric single-bundle ACL reconstruction.</p><p><strong>Method: </strong>Thirty-two 3-dimensional knee models were reconstructed based on CT scan (average age: 26.5 ± 6.7 years, 18 males and 14 females, 17 left and 15 right). Multiple anatomical landmarks were identified. Virtual femoral tunnels were created at the deep and high portion of ACL footprint, close to the lateral intercondylar ridge to achieve best anatomy and isometry, simulating an anteromedial portal reconstruction. Anatomical features of the femoral tunnels were analyzed. The position of the femoral tunnel was quantified by the distance to anatomical landmarks and using quadrant methods. The spatial angles, length and outer opening of the femoral tunnels were also evaluated.</p><p><strong>Results: </strong>Acceptable tunnels were created in all models. The center of femoral tunnel was slightly higher than the apex of deep cartilage, near the deep one-third point across the shallow-deep dimension of the lateral femoral condyle. Using the quadrant method, the tunnel was located at 28.4% ± 2.2% and 22.2% ± 3.6%, parallel and perpendicular to the Blumensaat line, respectively. The spatial angles of the tunnel were 40°, 33.5° ± 4.1° and 38.2° ± 4.4° on the sagittal, transverse, and coronal planes, respectively. The average tunnel length was 34.8 mm ± 3.8 mm. The outer opening of the tunnels was located at the posterior one-third of the femoral metaphysis.</p><p><strong>Conclusion: </strong>The anatomical and isometric positioning of the femoral tunnel can be achieved through anteromedial portal with satisfied tunnel characteristics. The apex of deep cartilage may be used as an anatomical reference for tunnel positioning. When drilled at appropriate orientation, favorable tunnel length, integrity and position of the outer opening can be obtained.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"822"},"PeriodicalIF":2.8,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of micro-movement on prevention of intraoperative acquired pressure injury in overweight patients undergoing posterior lumbar surgery: a randomized controlled trial.","authors":"Jing Zhang, Ping Wang, Li En Qi, Shuo Feng, Feng Zhang","doi":"10.1186/s13018-024-05312-8","DOIUrl":"10.1186/s13018-024-05312-8","url":null,"abstract":"<p><strong>Background: </strong>In posterior lumbar surgery, overweight patients are more prone to intraoperative acquired pressure injury (IAPI) due to bleeding, longer operative time, and increased pressure. The current prevention strategies have limited effects.</p><p><strong>Methods: </strong>This was a single-blind, prospective, randomized controlled trial conducted from April 2023 to September 2024. Eligible participants were overweight patients (BMI ≥ 24 kg/m²) scheduled for lumbar posterior surgery under general anesthesia. Patients were randomly assigned to two groups: the micro-movement group and the silicone foam dressing group. The micro-movement group had regular adjustments to the operating table to change the patient's position and alleviate pressure. The silicone foam dressing group used standard foam dressings at pressure points.</p><p><strong>Results: </strong>A total of 277 patients were included in the analysis (137 in the micromovement group and 140 in the silicone foam dressing group). Compared with the silicone foam dressing group (8.6%), the incidence of IAPI in the micromovement group was significantly reduced (2.9%) (P < 0.05). There were no significant differences between the two groups in terms of IAPI stage, duration, or location (P > 0.05).</p><p><strong>Conclusion: </strong>The micromovement protocol is a safe and effective method for preventing IAPI in overweight patients undergoing posterior lumbar surgery. This simple intervention could significantly improve patient outcomes and reduce healthcare costs associated with IAPI.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"823"},"PeriodicalIF":2.8,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616132/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A systematic comparative analysis of gait characteristics in patients undergoing total knee arthroplasty and unicompartmental knee arthroplasty: a review study.","authors":"Ming Zhang, Haoyue Wang, Zhiwei Cai, Haochong Zhang, Yifei Zhao, Xiaoran Zu, Cheng Wang, Xiang Li","doi":"10.1186/s13018-024-05308-4","DOIUrl":"10.1186/s13018-024-05308-4","url":null,"abstract":"<p><strong>Background: </strong>This study systematically reviews recent research comparing clinical outcomes and gait function changes in patients undergoing total knee arthroplasty (TKA) versus unicompartmental knee arthroplasty (UKA).</p><p><strong>Methods: </strong>A systematic search of the Web of Science, PubMed, and Embase databases was conducted, covering publications from January 2013 to September 2024, to identify studies evaluating changes in clinical scores and gait parameters in patients undergoing TKA or UKA. Following stringent selection criteria, data were synthesized from studies involving 171 TKA and 148 UKA patients, focusing on reported gait outcomes and aggregating findings for comprehensive analysis. Direct comparisons between TKA and UKA were performed to assess differences in clinical scores and gait parameters, aiming to elucidate the relative efficacy of each surgical approach and provide robust evidence for clinical decision-making.</p><p><strong>Results: </strong>Ten studies met the inclusion criteria for post-operative gait outcome comparisons between TKA and UKA, with seven studies also addressing clinical scores. One study reported greater improvement in WOMAC scores for the UKA group at 6 months post-operation (P < 0.05), while another found superior EQ-5D scores for UKA patients at 1 year post-surgery (P < 0.05). Conversely, five studies found no significant differences in clinical scores between groups at 1 year (P > 0.05). All ten studies assessed gait parameter recovery, with three studies showing no significant differences at 1 year (P > 0.05). However, seven studies identified superior gait recovery in the UKA group across various parameters, including walking speed, step and stride length, single support time, heel strike force, knee joint range of motion, knee flexion angles during different gait phases, peak knee adduction moment, peak tibial internal rotation moment, gait symmetry, and stride length symmetry (P < 0.05).</p><p><strong>Conclusions: </strong>The analysis indicates that UKA offers certain advantages in post-operative gait improvements compared to TKA, though these do not translate into significant differences in conventional clinical scoring systems. To enhance the reliability and generalizability of these findings, future studies should involve larger-scale, prospective randomized controlled trials.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"821"},"PeriodicalIF":2.8,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142780417","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mechanisms of tendon-bone interface healing: biomechanics, cell mechanics, and tissue engineering approaches.","authors":"Zhixiong Xu, Wensheng Xu, Tao Zhang, Long Luo","doi":"10.1186/s13018-024-05304-8","DOIUrl":"10.1186/s13018-024-05304-8","url":null,"abstract":"<p><p>The healing of tendon-bone contact surfaces involves complex biomechanical and biochemical interactions, with pivotal implications for sports medicine and rehabilitation. This review explores applications from cellular mechanics to tissue engineering, emphasizing how biomechanics impact tendon-bone healing. Cells regulate behavior, including growth, differentiation, and migration, by sensing mechanical signals and translating them into biochemical responses, which are critical in the healing process. Cellular mechanics modulate intracellular signaling, thereby influencing biological function and healing capacity. Optimizing tendon-bone interface repair involves modulating the extracellular mechanical environment. This includes physical stimulation, such as stretching, pressure, or vibration, to promote cellular alignment and enhance tissue structural integrity. Tissue engineering in tendon-bone healing focuses on designing scaffolds that mimic the biomechanical properties of the natural tendon-bone interface. Synthesizing these studies provides an in-depth understanding and utilization of biomechanical principles, significantly improving tendon-bone healing and offering new directions for clinical treatments to achieve better therapeutic outcomes and rehabilitation for patients with sports injuries.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"817"},"PeriodicalIF":2.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of collagen-based scaffolds with hydroxyapatite on the repair of cartilage defects in the rabbit knee joint.","authors":"Xiaoliang He, Qiuping Han, Yuxin Zhang, Huan Zhang, Jun Liu, Xiaohui Zhou","doi":"10.1186/s13018-024-05323-5","DOIUrl":"10.1186/s13018-024-05323-5","url":null,"abstract":"<p><strong>Background: </strong>The repair of articular cartilage defects is always a significant clinical challenge in joint treatment. Therefore, the aim of this study was to investigate that the ColII-HA-CS-HAP scaffolds with BMSCs could repair cartilage defects of knee.</p><p><strong>Methods: </strong>Bone marrow mesenchymal stem cells (BMSCs) were extracted from rabbits, identified using immunofluorescence staining, and successfully induced into chondrocytes. Type II collagen (ColII) was isolated from bovine cartilage and constructed into scaffolds with hyaluronic acid, chondroitin sulfate, and hydroxyapatite. Then BMSCs were seeded on the ColII-HA-CS-HAP scaffold to detect biocompatibility.</p><p><strong>Results: </strong>The results of DAPI fluorescence staining showed that the number of BMSCs on the ColII-HA-CS-HAP scaffolds increased rapidly after culturing for 12 d. The rabbit knee cartilage defect model with a diameter of approximately 3 mm and a thickness of approximately 4 mm was selected to evaluate the regenerative potential of the scaffolds using histological and immunohistochemical analyses. At 6 months, the regenerated cartilage in the ColII-HA-CS-HAP scaffolds with BMSCs was more similar to that of native cartilage than the ColII-HA-CS-HAP scaffold group.</p><p><strong>Conclusions: </strong>Our study proved that the ColII-HA-CS-HAP scaffolds with differentiated BMSCs can produce an excellent healing response and repair cartilage defects successfully in a rabbit model.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"818"},"PeriodicalIF":2.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Revision hip arthroscopy for hip synovial chondromatosis is effective despite inferior postoperative clinical outcomes compared to patients undergoing primary hip arthroscopy: a matched control study with minimum 2-year follow-up.","authors":"Yichuan Zhu, Xin Zhang, Jianquan Wang, Guanying Gao, Yan Xu","doi":"10.1186/s13018-024-05298-3","DOIUrl":"10.1186/s13018-024-05298-3","url":null,"abstract":"<p><strong>Purpose: </strong>(1) To determine the clinical outcomes following revision arthroscopy for patients with hip synovial chondromatosis (SC), and (2) to compare the clinical outcomes between patients undergoing revision hip arthroscopy and primary hip arthroscopy.</p><p><strong>Methods: </strong>Patients undergoing hip arthroscopy between December 2014 and January 2021 was reviewed. Patients treated for SC and confirmed by postoperative pathology were included. Exclusion criteria were age less than 18 years old, hip osteoarthritis (Tönnis grade > 1), history of autoimmune disease, avascular necrosis, and Legg-Calve-Perthes disease. Patients undergoing revision surgery were included in the revision group, while those undergoing primary surgery were matched in a 1:4 ratio and included in the primary group. Preoperative and postoperative patient-reported outcome (PRO) scores including Visual Analog pain Scale (VAS), modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), and international Hip Outcome Tool, 12-component form (iHOT-12) were collected and compared. The PROs and percentage of achieving minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) of mHHS, iHOT-12, and NAHS were compared between the two groups.</p><p><strong>Results: </strong>A total of 12 patients were included in the revision group, while 48 patients were included in the primary group. No significant difference was found in baseline characteristics (all with P > .05). No significant difference was found in the arthroscopic findings and procedures (all with P > .05). Both groups presented significant improvement of postoperative PROs compared to the preoperative PROs (all with P < .001). No significant difference was found in preoperative PROs between the two groups (all with P > .05). Postoperatively, the revision group presented inferior VAS (P = .007), mHHS (P = .007), iHOT-12 (P = .004), and NAHS (P = .028), as well as lower rate of achieving MCID of NAHS (P = .038), and PASS of mHHS (P = .003) compared to the primary group.</p><p><strong>Conclusion: </strong>Patients undergoing revision arthroscopy for hip SC presented favorable clinical outcomes at minimum of 2-year follow-up, although the postoperative PROs, rate of achieving MCID, and PASS were lower compared to patients undergoing primary arthroscopy.</p><p><strong>Level of evidence: </strong>III.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"819"},"PeriodicalIF":2.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the effect of phellodendrin application on rats creating an experimental model of non-compression lumbar disc herniation on the NF-κB-related inflammatory signaling pathway.","authors":"Panlin Tan, Jianbing Mei, Dong Wang","doi":"10.1186/s13018-024-05313-7","DOIUrl":"10.1186/s13018-024-05313-7","url":null,"abstract":"<p><strong>Objective: </strong>To explore the therapeutic effects of phellodendrine on non-compression lumbar disc herniation (NCLDH).</p><p><strong>Methods: </strong>The Sprague Dawley rat model of NCLDH was established via autologous caudal nucleus pulposus transplantation. Behavioral observations and neurological function scoring were conducted in Sprague Dawley rats, and the serum levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) were measured via enzyme-linked immunosorbent assay (ELISA). Real-time quantitative polymerase chain reaction (RT‒qPCR) was used to detect the expression of nuclear factor kappa-B (NF-κB) p65 mRNA in L5 nerve roots and surrounding tissues. Western blotting was used to assess the protein expression of NF-κB p65 and TNF-α. Immunofluorescence and immunohistochemical analyses were performed to investigate the distribution and expression of the NF-κB p65 protein in the L5 nerve and its surrounding tissues.</p><p><strong>Results: </strong>In this animal study, phellodendrine was found to downregulate the expression of p65 mRNA, decrease the release of inflammatory factors, and alleviate motor dysfunction caused by lumbar disc herniation(LDH). Therefore, the phellodendrine technique has potential value for the treatment of NCLDH.</p><p><strong>Conclusion: </strong>In this animal experiment, phellodendrine was found to significantly reduce the expression level of p65 mRNA, decrease the release of inflammatory cytokines, and alleviate lumbar disc pain.</p><p><strong>Clinical trial number: </strong>Not applicable.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"816"},"PeriodicalIF":2.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"En bloc resection of the ligamentum flavum for bilateral decompression in unilateral biportal endoscopic transforaminal lumbar interbody fusion: a 2-year follow-up study.","authors":"Chao Li, Beiyu Xu, Yao Zhao, Longtao Qi, Lei Yue, Ranlyu Zhu, Chunde Li, Zhengrong Yu","doi":"10.1186/s13018-024-05317-3","DOIUrl":"10.1186/s13018-024-05317-3","url":null,"abstract":"<p><strong>Background: </strong>Unilateral biportal endoscopic transforaminal lumbar interbody fusion (UBE-TLIF) is a minimally invasive procedure for treating lumbar degenerative diseases. However, the use of endoscopic lumbar interbody fusion does not completely eliminate the risk of dural and nerve root injuries. This study has refined UBE-TLIF to incorporate en bloc resection of the ligamentum flavum for bilateral decompression and aim to detail the surgical procedure and evaluate the clinical outcomes of this modification.</p><p><strong>Methods: </strong>This study analyzes the outcomes of 109 consecutive patients treated by a single surgeon for lumbar degenerative disease using UBE-TLIF. Patients were divided into two groups: Group A (51 patients) underwent en bloc resection of the ligamentum flavum, while Group B (58 patients) underwent routine piecemeal resection. Assessed outcomes included surgery-related complications, operation time, estimated blood loss, postoperative stay, visual analogue scale (VAS) score, and Oswestry Disability Index (ODI). The surgical technique is detailed within the study.</p><p><strong>Results: </strong>In Group A, no nerve root or dura injuries were observed, whereas Group B reported one case of nerve root injury and three dura tears. The average operation time for Group A was shorter than that for Group B; however, the difference was not statistically significant (P > 0.05). No significant differences were found in the VAS score, ODI, estimated blood loss, or postoperative stay between the groups during follow-up.</p><p><strong>Conclusions: </strong>En bloc resection of the ligamentum flavum for bilateral decompression in UBE-TLIF demonstrates satisfactory clinical outcomes and low perioperative complications rates, offering a safe and innovative alternative for the treatment of lumbar degenerative disease.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"815"},"PeriodicalIF":2.8,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613677/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FOXA1 knockdown alleviates inflammation and enhances osteogenic differentiation of periodontal ligament stem cells via STAT3 pathway.","authors":"Jin Wang, Yanru Zhu","doi":"10.1186/s13018-024-05286-7","DOIUrl":"10.1186/s13018-024-05286-7","url":null,"abstract":"<p><strong>Background: </strong>Evidence has confirmed that forkhead box protein A1 (FOXA1) inhibits the osteogenic differentiation of bone marrow mesenchymal stem cells. However, whether FOXA1 regulates the osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs) to participate in periodontitis process is unclear.</p><p><strong>Methods: </strong>Lipopolysaccharide (LPS) was used to treat hPDLSCs to mimic inflammation environments. FOXA1 expression was examined by quantitative real-time PCR and western blot. The levels of IL-6 and TNF-α were evaluated by quantitative real-time PCR, ELISA and immunohistochemistry staining. hPDLSCs osteogenic differentiation was assessed by measuring alkaline phosphatase activity, alizarin red S intensity and the levels of osteogenic differentiation-related markers. Besides, the expression of signal transducer and activator of transcription 3 (STAT3) pathway-related markers were examined by western blot and immunofluorescence staining.</p><p><strong>Results: </strong>FOXA1 was upregulated in the periodontal ligament tissues of periodontitis patients, and its knockdown enhanced osteogenic differentiation of hPDLSCs. Besides, downregulation of FOXA1 suppressed inflammation levels in LPS-induced hPDLSCs. Also, FOXA1 silencing promoted the osteogenic differentiation of LPS-induced hPDLSCs by the inactivation of STAT3 pathway.</p><p><strong>Conclusion: </strong>Our data confirmed that knockdown of FOXA1 attenuated inflammation and enhanced osteogenic differentiation of LPS-induced hPDLSCs by regulating STAT3 pathway, indicating that FOXA1 might be a target for periodontitis treatment.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"814"},"PeriodicalIF":2.8,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2.","authors":"Mikkel Ø Andersen, Andreas K Andresen, Jan Hartvigsen, A Pernille Hermann, Jan Sørensen, Leah Y Carreon","doi":"10.1186/s13018-024-05301-x","DOIUrl":"10.1186/s13018-024-05301-x","url":null,"abstract":"<p><strong>Background: </strong>One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients' daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema.</p><p><strong>Methods: </strong>Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed.</p><p><strong>Discussion: </strong>With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines.</p><p><strong>Trial registration: </strong>The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023.</p>","PeriodicalId":16629,"journal":{"name":"Journal of Orthopaedic Surgery and Research","volume":"19 1","pages":"813"},"PeriodicalIF":2.8,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}