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NCT Number: NCT02664545

Bridge-Enhanced ACL Repair vs ACL Reconstruction

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEAR Scaffold

Device

A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.

Tendon Graft

Procedure

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)

Primary outcomes

  1. 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).

  2. 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

  1. Prone Hamstring Strength at 6 Months

    Time frame: 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.

  2. Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Miach Orthopaedics

Industry

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2028
First posted
Jan 27, 2016
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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