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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anterior Cruciate Ligament Tear
- Sponsor
- Miach Orthopaedics
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- International Knee Documentation Committee (IKDC) Subjective
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
International Knee Documentation Committee (IKDC) Subjective
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Prone Hamstring Strength at 6 Months(6 months)
- Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.(6 months)