Phase 4 Recruiting NCT04130700

Bridge-enhanced ACL repair versus reconstruction (BEAR-III)

Boston Children's Hospital · Interventional, Randomized 2:1 (BEAR to reconstruction) · n=200

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Medicine Knee Ligament Injury (ACL Tear)

Overview

The Bridge-Enhanced ACL Restoration (BEAR) implant is designed to enable the body to heal a torn anterior cruciate ligament rather than replacing it with a tendon graft. BEAR-III is the extension study comparing knee function, return-to-sport rates, and re-injury rates between BEAR repair and conventional ACL reconstruction in a younger, athletically-active population.

Full record on ClinicalTrials.gov (NCT ID NCT04130700).

Eligibility

Inclusion criteria

- Age 13–35 years at screening - Acute complete ACL tear within 50 days of injury - ACL remnant length ≥ 50% of original on MRI - Participation in cutting/pivoting sports prior to injury

Exclusion criteria

- Concurrent grade III MCL injury requiring surgical repair - Previous ACL injury on the same knee - BMI > 35 - Inability to comply with 2-year follow-up

Age range: 13–35 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase: Phase 4
Study type: Interventional
Allocation: Randomized 2:1 (BEAR to reconstruction)
Masking: Single-blind (outcomes assessor)
Intervention model: Parallel assignment
Primary purpose: Treatment
Enrollment target: 200 participants
Started: April 2023
Estimated completion: June 2027

Outcome measures

Primary endpoint

International Knee Documentation Committee (IKDC) subjective score at 24 months

Secondary endpoints

- Return to pre-injury level of sport - Re-injury rate at 24 months - KT-1000 arthrometer side-to-side difference - Patient-reported outcomes (KOOS subscales)

Locations & contacts

Showing 1 of 1 sites

1 site currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Boston Children's Hospital — Sports Medicine Division — Boston, MA

Principal Investigator: Martha M. Murray, MD · Status: Recruiting

Sources

REG

ClinicalTrials.gov — NCT04130700

Trial registry · primary record