A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Device: The BEAR® Implant

• Registration Number: NCT05398341
• Lead Sponsor: Miach Orthopaedics

Brief Summary

The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.

Detailed Description

This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.

Study Timeline

• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Study First Posted: 2022-05-31
• Study Start: 2023-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-10-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1. The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Cohort	The BEAR® Implant	A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group.
Prospective Cohort	The BEAR® Implant	There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent.

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2	2 Years	This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
Knee laxity based on the Lachman test at 1 year	1 year	The Lachman will be performed during physical exam.

Secondary Outcome Measures

Name	Time	Method
Marx Activity Score at 6, 9, 12 months and at 2 years after surgery	6 months thru 2 years	Patients are asked to indicate approximately how many times in the past 12 months they performed each of these activities while at their healthiest and most active state. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a maximum of 16 points with a higher score indicating more frequent participation.
IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care	6-12 months	This is an examination performed of the knee. Scores are one of four measures: A (Normal), B (Nearly Normal), C (Abnormal) and D (Severely Abnormal). A is the best outcome and D is the worst.
Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery	6 months thru 2 years	Measures the patients emotion, confidence, and risk appraisal when returning to sports after an ACL injury and/or reconstructive surgery. There are 12 questions and the subjects answer each in range is from 0 to 100. The response scale meaning is dictated by the question. The sum of all questions are reported, divided by 12,000 and multiplied by 100 to get a %.
VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery	1 year	A tool widely used to measure pain. The patient indicates his/her perceived pain intensity along a 100 mm horizontal line and this rate is then measure from the left edge to give a score.
Current Status Questionnaire	2 years	Elements include return to activity, pain medication use. No Score.
Pain Medication Use	2 years	Administered by questionnaire. No score.
Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery	6 months- 2 years post surgery	This is a survey with 5 subscales (Pain, Symptoms, Function in Daily Living, Function in Sport and Recreation, and Knee Related Quality of Life). The range of each subscale is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems. The subscales are reported individually and not combined.

Trial Locations

Locations (9)

Stanford; 🇺🇸 Redwood City, California, United States

Advent Health; 🇺🇸 Orlando, Florida, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Virtua Health; 🇺🇸 Marlton, New Jersey, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Steamboat Orthopaedic and Spine Institute; 🇺🇸 Steamboat Springs, Colorado, United States

Victory Sports Medicine; 🇺🇸 Skaneateles, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Oregon Health & Science University (OHSU); 🇺🇸 Portland, Oregon, United States