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New ACL implant under Real-World watch: does it hold up?

NCT ID NCT05398341

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

14 years and older

Sex

Anyone

Healthy volunteers

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

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.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 32804, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239, United States

  • Stanford

    Redwood City, California, 94063, United States

  • Steamboat Orthopaedic and Spine Institute

    Steamboat Springs, Colorado, 80487, United States

  • Victory Sports Medicine

    Skaneateles, New York, 13152, United States

  • Virtua Health

    Marlton, New Jersey, 08053, United States

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