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New scaffold could help heal torn ACLs without full reconstruction

NCT ID NCT02292004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device called the MIACH scaffold, which is placed inside a torn anterior cruciate ligament (ACL) to help it heal. Twenty people with complete ACL tears will take part: half will get the scaffold plus standard repair, and half will get standard ACL reconstruction. The main goal is to check if the scaffold is safe and well-tolerated.

What this could mean

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

Active substance
MIACH scaffold (BEAR Implant)
What this could lead to
If it works, this could offer a way to repair a torn ACL instead of replacing it, potentially leading to better long-term knee function.
What could go wrong
This is a very small, early safety study with only 20 participants. The new device may not heal the ligament as well as standard surgery, and there are risks like infection or rejection.

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

20 people

The number who actually took part.

Started

Jan 2015

Expected to finish

Dec 2026

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

18 to 35 years

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: * Complete ACL tear, confirmed by MRI * Time from injury to screening must be less than or equal to 90 days * ACL tissue present on pre-operative MRI Exclusion Criteria (before surgery): * Prior surgery on affected knee * History of prior infection in affected knee * Regular use of tobacco or nicotine in any form * Use of corticosteroid within last 6 months * Ever underwent chemotherapy treatment * History of sickle cell disease * History of anaphylaxis * Any condition that could affect healing (Diabetes, inflammatory arthritis, etc) * Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) * Diagnosis of Grade III medial collateral ligament injury * Diagnosis of complete patellar dislocation Exclusion Criteria (during surgery): * ACL deemed normal on arthroscopic inspection * Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group) * Experimental Group: Less than 50 percent of ACL remaining * Displaced bucket handle meniscal injury requiring repair * Diagnosis of full-thickness chondral injury on either condyle * Grade III medial collateral ligament injury

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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 injury Anterior cruciate ligament tear

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.