Evaluating outcomes of the BEAR Implant for ACL injuries
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
This study is testing how well the BEAR Implant works for people having surgery for ACL injuries by looking at both new patients and those who have already had the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Miach Orthopaedics Industry-sponsored |
| Locations | 9 sites (Redwood City, California and 8 other locations) |
| Trial ID | NCT05398341 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the real-world performance of the FDA-approved BEAR Implant used in ACL surgeries. It will enroll consecutive patients scheduled for ACL surgery with the BEAR Implant, who are willing to provide consent. The study includes both a prospective cohort of new patients and a retrospective cohort of patients who have already undergone surgery with the implant. There is no control group, allowing for a comprehensive evaluation of outcomes in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for ACL surgery who are willing to use the BEAR Implant and provide informed consent.
Not a fit: Patients currently participating in other ACL trials or those with known allergies to components of the BEAR Implant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of the BEAR Implant for ACL injuries.
How similar studies have performed: While this approach is observational, similar studies evaluating new surgical implants have shown promising results in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Redwood City, California and 8 other locations
- Stanford — Redwood City, California, United States (Recruiting)
- Steamboat Orthopaedic and Spine Institute — Steamboat Springs, Colorado, United States (Active_not_recruiting)
- Advent Health — Orlando, Florida, United States (Active_not_recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Virtua Health — Marlton, New Jersey, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
- Victory Sports Medicine — Skaneateles, New York, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Active_not_recruiting)
- Oregon Health & Science University (OHSU) — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Rita Paparazzo, BS/MBA
- Email: clinicaltrials@miachortho.com
- Phone: 508-736-1309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.