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New sponge could replace tendon graft for ACL tears

NCT ID NCT02664545

Disease control Sponsor: Miach Orthopaedics Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new device called BEAR to standard ACL reconstruction surgery. BEAR uses a special sponge placed between the torn ends of the ligament to help it heal back together, while standard surgery uses a tendon graft from elsewhere in the knee. The trial includes 100 people aged 14 to 35 with complete ACL tears. Researchers will measure knee function and stability over 10 years to see if the new method works as well as the current one.

What this could mean

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

Active substance
BEAR Scaffold (a sponge placed between torn ligament ends to help it heal)
What this could lead to
If it works, this could offer a way to repair a torn ACL without removing a tendon from elsewhere, potentially leading to faster recovery and less long-term knee problems.
What could go wrong
This is a relatively small, early-stage trial (100 people) comparing a new device to a well-established surgery. The new method may not be as effective or could have unexpected complications like re-tear or stiffness.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Apr 2016

Expected to finish

May 2028

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.

Ages

14 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age: 14 to 35 years of age. * Sex: Both male and female * ACL: Complete tear * Time from injury to surgery: ≤45 days * MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau Exclusion Criteria: * Prior surgery on affected knee * Prior joint infection on affected knee * Regular use of tobacco or nicotine * Use of corticosteroid within last 3 months * History of chemotherapy treatment * History of sickle cell disease * History of anaphylaxis * Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc) * Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) * Grade III medial collateral ligament injury * Complete patellar dislocation * Known allergy to bovine, beef or cow products

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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.

Anterior cruciate ligament tear

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

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