BEAR-MOON: A Two Arm Noninferiority Blinded Randomized Clinical Trial Comparing ACL Repair with BEAR Device vs. Standard of Care Autograft Patellar Tendon ACL Reconstruction

BEAR-MOON：一项两臂非劣效性盲法随机临床试验，比较使用 BEAR 装置进行 ACL 修复与自体移植髌腱 ACL 重建的护理标准

• 批准号: 10476991
• 负责人: Kurt Paul Spindler
• 金额: $ 115.3万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10476991
• 关键词: Affect; Age-Years; Animal Model; Anterior; Anterior Cruciate Ligament; Area; Autologous; Autologous Transplantation; Biological; Biological Response Modifier Therapy; Blinded; Blood; Clinical Trials; Cohort Studies; Complex; Data; Degenerative polyarthritis; Devices; Documentation; Enrollment; Environment; FDA approved; Failure; Foundations; Funding; Gold; Harvest; Human; Inferior; Injury; International; Joints; Knee; Knee Osteoarthritis; Lead; Ligaments; Measures; Meniscus structure of joint; Meteor; Modeling; Operative Surgical Procedures; Orthopedics; Outcome; Outcome Measure; Pathology; Patient Outcomes Assessments; Patients; Physical Examination; Pre-Clinical Model; Preclinical Testing; Prevention; Procedures; Protocols documentation; Randomized; Randomized Clinical Trials; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regenerative Medicine; Research Personnel; Rotator Cuff; Running; Safety; Scaffolding Protein; Site; Statistical Data Interpretation; Structure; Synovial Fluid; Techniques; Technology; Tendon structure; Testing; Time; Tissue Engineering; Tissue Harvesting; Tissues; United States National Institutes of Health; Work; anterior cruciate ligament healing; anterior cruciate ligament injury; anterior cruciate ligament reconstruction; anterior cruciate ligament rupture; arm; clinical outcome measures; clinical practice; clinical translation; co-clinical trial; cohort; delivery vehicle; efficacy outcomes; effusion; experience; first-in-human; healing; health related quality of life; mechanical properties; novel; patellar tendon; pre-clinical; preclinical study; premature; primary endpoint; primary outcome; repaired; scaffold; standard of care; success; trial comparing; wound healing

PROJECT SUMMARY Tissues which live within joints, including the anterior cruciate ligament, rotator cuff tendon, meniscus and labrum fail to heal spontaneously after injury and have high failure rates of surgical repair. The ACL represents a good model to study the problem of intra-articular healing as there are validated preclinical models and clinical outcome measures that make it possible to critically evaluate the success or failure of strategies to enhance tissue healing. The current standard of care for ACL injuries is ACL reconstruction, which is good at stabilizing the knee but requires compromising other uninjured structures around the knee to obtain a graft that is subsequently used to replace the ACL. Further the early posttraumatic OA is not mitigated despite ACL reconstruction. The preclinical studies on ACL repair called BEAR (Bridge-Enhanced ACL Repair) demonstrated a prevention of posttraumatic OA and achieved knee stability. The positive preclinical findings of BEAR compared to ACL reconstruction provided the foundation for two FDA approved preliminary clinical trials: 1) the first-in-human cohort study (“BEAR I”), and 2) a small, single-center randomized control trial (“BEAR II”). The statistical analysis of our pilot data shows a 200 patient trial will be required to demonstrate non-inferiority of BEAR (a novel paradigm changing technology) when compared to ACL reconstruction (current gold standard) for the key outcomes of anterior-posterior (AP) knee laxity and a validated patient reported outcome for knee surgery. Therefore we propose the BEAR-MOON (Bridge-Enhanced ACL Repair) multi-center randomized non-inferiority clinical trial for co-primary outcomes AP (anterior-posterior) knee laxity and International Knee Documentation Committee (IKDC) validated patient reported outcome measure. The subjects will be between 18 and 40 years of age with a complete ACL tear and randomized to either 1) ACL Reconstruction with patellar tendon autograft (ACLR) or 2) Bridge-Enhanced ACL Repair (BEAR). We will follow subjects at 6 months, 1 and 2 years after surgery. While achieving these aims has the potential to change the clinical practice of ACL surgery, the impact is potentially far greater, as the availability of an FDA- approved carrier that can be used to deliver complex biologic therapies to tissues within joints could enable the clinical translation of the preclinical studies being conducted in multiple areas of regenerative medicine by providing a delivery vehicle for these therapies.

项目总结

项目成果

Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial.

• DOI: 10.1177/23259671211065447
• 发表时间: 2022-01
• 期刊: Orthopaedic journal of sports medicine
• 影响因子: 2.6
• 作者: BEAR-MOON Design Group;Spindler KP;Imrey PB;Yalcin S;Beck GJ;Calbrese G;Cox CL;Fadale PD;Farrow L;Fitch R;Flanigan D;Fleming BC;Hulstyn MJ;Jones MH;Kaeding C;Katz JN;Kriz P;Magnussen R;McErlean E;Melgaard C;Owens BD;Saluan P;Strnad G;Winalski CS;Wright R
• 通讯作者: Wright R

Interrater Agreement of an Arthroscopic Anterior Cruciate Ligament Tear Classification System.

• DOI: 10.1177/2325967120966323
• 发表时间: 2020-12
• 期刊: Orthopaedic journal of sports medicine
• 影响因子: 2.6
• 作者: BEAR-MOON;Vega JF;Strnad GJ;Briskin I;Cox CL;Farrow LD;Fadale P;Flanigan D;Hulstyn M;Imrey PB;Kaeding CC;Owens BD;Saluan P;Wright R;Yen YM;Spindler KP
• 通讯作者: Spindler KP