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

N/AActive Not RecruitingNCT05398341

Miach Orthopaedics300 enrolled

Overview

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

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

300

Conditions

Anterior Cruciate Ligament Injuries

Interventions

The BEAR® ImplantDEVICE

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.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (9)

Stanford

Redwood City, California, United States

Steamboat Orthopaedic and Spine Institute

Steamboat Springs, Colorado, United States

Advent Health

Orlando, Florida, United States

Boston Children's Hospital

Outcomes

Primary Outcomes

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.

Time frame: 2 Years

Knee laxity based on the Lachman test at 1 year

The Lachman will be performed during physical exam.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.