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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)
Boston Children's Hospital
Boston, Massachusetts, United States
International Knee Documentation Committee (IKDC) Subjective
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).
Time frame: 2 years after surgery
Instrumented Anteroposterior (AP) Laxity Testing
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.
Time frame: 2 years after surgery
Prone Hamstring Strength at 6 Months
Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee.
Time frame: 6 months
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores.
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Time frame: 6 months