Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial.
Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial.
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DOI：
10.1177/23259671211065447
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发表时间：
2022-01
影响因子：
2.6
通讯作者：
Wright R
中科院分区：
文献类型：
--
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
BEAR（桥式增强前交叉韧带[ACL]修复）是一种范式转换技术，用于治疗中间韧带撕裂，在单中心2:1随机对照试验（RCT）中被证明与腘绳肌腱前交叉韧带重建相比是有效的。BEAR在临床实践中的广泛传播也应该通过多中心随机对照试验来证明可移植性，并与另一种临床标准治疗骨-髌骨肌腱-骨（BPTB） ACL重建进行疗效比较。介绍BEAR与BPTB ACL重建的多中心随机对照试验的设计和初步准备（BEAR：多中心骨科预后网络[BEAR- moon]试验）。涉及美国国家关节炎、肌肉骨骼和皮肤疾病研究所、美国食品和药物管理局、BEAR植入物制造商、数据和安全监测委员会以及机构审查委员会的复杂BEAR- moon试验计划中的设计和分析问题，可以有效地告知临床医生试验的优势和局限性，以及未来研究人员对复杂骨科研究计划的了解。临床试验。我们描述了比较创新BEAR手术与成熟的BPTB手术的独特临床、方法学和操作挑战，并概述了BEAR- moon试验的临床动机、实验环境、研究设计、手术挑战、康复、结果测量和计划分析。BEAR- moon是一项6个中心、12位外科医生、200名患者的随机、部分盲、非低效性随机对照试验，比较BEAR与BPTB前交叉韧带重建治疗首次中质性前交叉韧带撕裂。如果国际膝关节文献委员会（IKDC）主观膝关节评估表的总分和膝关节计30磅（13.61公斤）的侧向松弛度差均在IKDC的16分和膝关节松弛度2.5毫米的范围内，则BEAR相对于BPTB的非劣效性将被声明。主要问题包括患者选择、术中随机化和治疗特异性术后物理治疗方案的需求（因为手术技术、初始稳定性结构和愈合的根本差异），以及对具有明显短期优势和理论上但未经验证的其他维度的长期益处的新型干预措施的短期疗效结果的非劣效边际的选择。
BEAR (bridge-enhanced anterior cruciate ligament [ACL] restoration), a paradigm-shifting technology to heal midsubstance ACL tears, has been demonstrated to be effective in a single-center 2:1 randomized controlled trial (RCT) versus hamstring ACL reconstruction. Widespread dissemination of BEAR into clinical practice should also be informed by a multicenter RCT to demonstrate exportability and compare efficacy with bone--patellar tendon–bone (BPTB) ACL reconstruction, another clinically standard treatment. To present the design and initial preparation of a multicenter RCT of BEAR versus BPTB ACL reconstruction (the BEAR: Multicenter Orthopaedic Outcomes Network [BEAR-MOON] trial). Design and analytic issues in planning the complex BEAR-MOON trial, involving the US National Institute of Arthritis and Musculoskeletal and Skin Diseases, the US Food and Drug Administration, the BEAR implant manufacturer, a data and safety monitoring board, and institutional review boards, can usefully inform both clinicians on the trial’s strengths and limitations and future investigators on planning of complex orthopaedic studies. Clinical trial. We describe the distinctive clinical, methodological, and operational challenges of comparing the innovative BEAR procedure with the well-established BPTB operation, and we outline the clinical motivation, experimental setting, study design, surgical challenges, rehabilitation, outcome measures, and planned analysis of the BEAR-MOON trial. BEAR-MOON is a 6-center, 12-surgeon, 200-patient randomized, partially blinded, noninferiority RCT comparing BEAR with BPTB ACL reconstruction for treating first-time midsubstance ACL tears. Noninferiority of BEAR relative to BPTB will be claimed if the total score on the International Knee Documentation Committee (IKDC) subjective knee evaluation form and the knee arthrometer 30-lb (13.61-kg) side-to-side laxity difference are both within respective margins of 16 points for the IKDC and 2.5 mm for knee laxity. Major issues include patient selection, need for intraoperative randomization and treatment-specific postoperative physical therapy regimens (because of fundamental differences in surgical technique, initial stability construct, and healing), and choice of noninferiority margins for short-term efficacy outcomes of a novel intervention with evident short-term advantages and theoretical, but unverified, long-term benefits on other dimensions.
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DOI：
10.1177/0363546515578836
发表时间：
2015-07
期刊：
The American journal of sports medicine
影响因子：
--
作者：
Kaeding CC;Pedroza AD;Reinke EK;Huston LJ;MOON Consortium;Spindler KP
通讯作者：
Spindler KP
DOI：
10.1136/bmj.f232
发表时间：
2013-01-24
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Frobell RB;Roos HP;Roos EM;Roemer FW;Ranstam J;Lohmander LS
通讯作者：
Lohmander LS
DOI：
10.1177/0363546514525910
发表时间：
2014-05
期刊：
The American journal of sports medicine
影响因子：
--
作者：
Cox CL;Huston LJ;Dunn WR;Reinke EK;Nwosu SK;Parker RD;Wright RW;Kaeding CC;Marx RG;Amendola A;McCarty EC;Spindler KP
通讯作者：
Spindler KP
影响因子：
158.5
作者：
Frobell, Richard B.;Roos, Ewa M.;Lohmander, L. Stefan
通讯作者：
Lohmander, L. Stefan
影响因子：
4.8
作者：
Biercevicz, Alison M.;Miranda, Daniel L.;Fleming, Braden C.
通讯作者：
Fleming, Braden C.