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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Device: The 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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford
  • Colorado
    • Steamboat Springs, Colorado, United States, 80487
      • Steamboat Orthopaedic and Spine Institute
  • Florida
    • Orlando, Florida, United States, 32804
      • Advent Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02453
      • Boston Children's Hospital
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Virtua Health
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • Skaneateles, New York, United States, 13152
      • Victory Sports Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University (OHSU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.

Description

Inclusion Criteria for Prospective Cohort:

1. Scheduled to undergo ACL surgery with the BEAR Implant
2. Willing and able to provide informed consent
3. Willing and able to complete required follow-up visits and assessments

Inclusion Criteria for Retrospective Cohort:

1. Underwent ACL surgery with the BEAR Implant

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Cohort; There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent.	Device: The BEAR® Implant; The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.
Retrospective Cohort; A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group.	Device: The BEAR® Implant; The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy [BSE] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2	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.	2 Years
Knee laxity based on the Lachman test at 1 year	The Lachman will be performed during physical exam.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care	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.	6-12 months
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	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.	6 months- 2 years post surgery
Marx Activity Score at 6, 9, 12 months and at 2 years after surgery	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.	6 months thru 2 years
Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery	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 %.	6 months thru 2 years
VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery	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.	1 year
Current Status Questionnaire	Elements include return to activity, pain medication use. No Score.	2 years
Pain Medication Use	Administered by questionnaire. No score.	2 years

Collaborators and Investigators

• Sponsor: Miach Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ACL; ACL tear; ACL surgery; Torn ACL; BEAR Implant; BEAR ACL; BEAR restoration; Bridge-enhanced ACL restoration; ACL restoration; ACL implant bridge
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: Bridge Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No