New ACL implant under Real-World watch: does it hold up?
NCT ID NCT05398341
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study follows 300 people who had ACL surgery using the BEAR Implant to see how well their knees heal and function over two years. Participants complete knee surveys and physical exams at regular visits. The goal is to confirm the implant's real-world safety and effectiveness for repairing torn knee ligaments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.
- Ages
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14 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Advent Health
Orlando, Florida, 32804, United States
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Duke University
Durham, North Carolina, 27705, United States
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Hospital for Special Surgery
New York, New York, 10021, United States
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Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
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Stanford
Redwood City, California, 94063, United States
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Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, 80487, United States
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Victory Sports Medicine
Skaneateles, New York, 13152, United States
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Virtua Health
Marlton, New Jersey, 08053, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can ACL surgery recovery skip the opioids?
- Can a surgical device prevent stiff knee after ACL surgery?
- Can online therapy boost ACL recovery and return to sport?
- Can a 3D-Printed gadget speed up knee recovery?
- Saving the ligament: a trial tests whether repairing a torn ACL beats replacing it
- Which tendon graft helps female athletes recover best after ACL surgery?