Arthroscopic Repair versus Reconstruction for Proximal Anterior Cruciate Ligament Tears: A Multi-Center Randomized Controlled Trial
Phase 2
- Conditions
- Patients with proximal ACL tear requiring surgeryAnterior cruciate ligament, Repair, Reconstruction, Clinical outcomes, Complications, Re-injury
- Registration Number
- TCTR20231002010
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
1. Pre-operative inclusions
- Complete primary ACL tear on MRI
- Proximal tear on MRI
- Age 18-50 years
- Operation < 8 weeks after injury
2. Intra-operative inclusions
- Sufficient tissue length
- Sufficient tissue quality
Exclusion Criteria
- Complete ipsilateral concomitant knee ligament injury requiring surgery
- Osteoarthritis KL grade more than grade 2
- Previous ipsilateral ACL reconstruction/repair
- Grade 3 pivot shift indicating gross ligament instability
- Gross lower leg malalignment requiring bony osteotomies
- Pregnancy during injury or surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IKDC score at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery Using a questionnaire interview,Tegner score at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery Using a questionnaire interview,Lysholm score at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery Using a questionnaire interview,Anterior tibial translation (side-to-side difference) at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery Using Lachmeter to measure the anterior translation of injured and normal knees
- Secondary Outcome Measures
Name Time Method Failure When the patient reported knee instability. Patients reported instability and confirmed by MRI.,Return to sports at 6 months and 1 year after surgery Using an ACL-RSI questionnaire interview