A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- International Knee Documentation Committee (IKDC) Subjective
研究概览
简要总结
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
详细描述
Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 14 to 35 years of age.
- •Sex: Both male and female
- •ACL: Complete tear
- •Time from injury to surgery: ≤45 days
- •MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau
排除标准
- •Prior surgery on affected knee
- •Prior joint infection on affected knee
- •Regular use of tobacco or nicotine
- •Use of corticosteroid within last 3 months
- •History of chemotherapy treatment
- •History of sickle cell disease
- •History of anaphylaxis
- •Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc)
- •Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
- •Grade III medial collateral ligament injury
- •Complete patellar dislocation
- •Known allergy to bovine, beef or cow products
结局指标
主要结局
International Knee Documentation Committee (IKDC) Subjective
时间窗: 2 years after surgery
This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Instrumented Anteroposterior (AP) Laxity Testing
时间窗: 2 years after surgery
This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant.
次要结局
- Prone Hamstring Strength at 6 Months(6 months)
- Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.(6 months)