Bridge-Enhanced ACL Repair vs ACL Reconstruction

Not Applicable

Active, not recruiting

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).

Recruitment & Eligibility

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
Complete patellar dislocation
Known allergy to bovine, beef or cow products

Arm && Interventions

Group	Intervention	Description
Bridge-Enhanced ACL Repair (BEAR)	BEAR Scaffold	The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.
Tendon Graft	Tendon Graft	ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) Subjective	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	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 Outcome Measures

Name	Time	Method
Prone Hamstring Strength at 6 Months	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.
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.	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.