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Knee surgery gets a boost: BioBrace scaffold tested in 500 patients

NCT ID NCT06948591

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called BioBrace, a special scaffold that wraps around a tissue graft during ACL knee surgery to make it stronger. Researchers will follow 500 people aged 14 to 70 for up to 3 years to see if it improves knee function and is safe. The goal is to help patients recover better and avoid future knee problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioBrace Reinforced Implant (a bioresorbable collagen and PLLA scaffold used to reinforce soft tissue grafts during ACL reconstruction)
What this could lead to
If successful, BioBrace could help people with ACL tears recover better knee function and reduce the risk of re-injury after surgery.
What could go wrong
This is a real-world study without a comparison group, so it cannot prove BioBrace is better than standard ACL surgery. The device may not improve outcomes and could cause side effects like infection or graft failure.

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 500 people

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

Started

Apr 2025

Expected to finish

Jun 2030

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

Community surrounding participating hospitals / clinics.

Ages

14 to 70 years

Sex

Anyone

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: 1. Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®. 2. Between 14 and 70 years old at the time of surgery. 3. Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study. 4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection. 5. If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively: 1. International Knee Documentation Committee (IKDC) 2. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.) 3. Patient-Reported Outcomes Measurement Information System (PROMIS-10) 4. Tegner Activity Scale (TAS) 5. Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI) 6. Positive diagnostic imaging by MRI at baseline indicating an ACL tear Exclusion Criteria: 1. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study. 2. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study. 3. Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively). 4. Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ConMed

    RECRUITING

    New Haven, Connecticut, 06513, United States

    Contact Email: •••••@•••••

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