Can a Blood-Soaked sponge regrow a torn ACL?

NCT ID NCT03776162

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests a new way to fix a torn anterior cruciate ligament (ACL) in the knee. Instead of replacing the ligament with a tendon graft from another part of the knee, the BEAR technique places a blood-soaked sponge between the torn ends to help them heal back together. Researchers will compare this to the standard patellar tendon graft surgery in 150 people aged 18 to 55, measuring knee stability and patient-reported outcomes over two years. The goal is to see if BEAR is not worse than standard surgery while being less invasive.

What this could mean

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

Active substance
Bridge Enhanced ACL Restoration (BEAR) device, a blood-soaked sponge placed between torn ACL ends to promote healing, compared to standard patellar tendon autograft reconstruction.
What this could lead to
If BEAR works as well as standard surgery, it could offer a less invasive ACL repair that avoids taking a tendon from elsewhere in the knee, potentially reducing pain and recovery time.
What could go wrong
This is a mid-sized trial, and the new technique may not match the standard surgery's results. Also, any potential long-term benefit for preventing knee arthritis is not yet proven in humans.

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

150 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 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 In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. 18-55 years of age 2. Complete ACL tear as confirmed by MRI 3. Selected surgical treatment of ACL injury 4. Believed to be a surgical candidate for ACL reconstruction by treating physician 5. Time from injury to surgery is ≤50 days 6. Stated willingness to comply with all study procedures for the duration of the study, including lifestyle, activity, and sports restrictions 7. Provision of signed and dated informed consent form EXCLUSION CRITERIA AT PRE-OPERATIVE EXAM An individual who meets any of the following criteria, either during a pre-operative exam or during intraoperative arthroscopic evaluation, will be excluded from participation in this study: 1. Any prior ACL surgery on affected knee (except simple arthroscopy for plica, debris removal, or diagnosis) 2. Any prior ACL surgery on unaffected knee (except simple arthroscopy for plica, debris removal, diagnosis or partial meniscectomy) 3. Confirmed or suspected contralateral ACL tear 4. ACL tear found to be only partial and the treating physician feels it does not require surgery because it is "stable" 5. Diagnosis of posterolateral corner injury (complete lateral collateral ligament tear, biceps femoris tendon avulsion, arcuate ligament tear, popliteus ligament tear) that requires concurrent or staged surgical treatment 6. Diagnosis of Grade III medial collateral injury that requires concurrent or staged surgery 7. Insufficient ACL tissue on MRI 8. Diagnosis of complete patellar dislocation 9. Diagnosis of complete patellar tendon or quadriceps tear 10. Obesity with a BMI ≥45 11. Does not speak or understand English 12. Daily smoking (occasional or social use is accepted if smoking ≤ 3 days/ week and ≤ 5 cigarettes/day) 13. Documented history of illicit drug or alcohol abuse (except for recreational use of marijuana) 14. Inability to take oral medications 15. Use of intra-articular corticosteroids in the affected knee within last 6 months 16. Chronic use of corticosteroids for treatment of an autoimmune disorder such as lupus, rheumatoid arthritis, etc. (maintenance or rescue inhaler for asthma is allowed) 17. History of prior infection in knee 18. History of chemotherapy treatment 19. History of sickle cell disease 20. History of anaphylaxis, requiring a documented medical intervention 21. Any condition that, in the opinion of the investigator, could affect healing (e.g., diabetes, inflammatory arthritis, etc.) 22. Pregnancy or lactation 23. Known allergic reactions to meat products or collagen 24. Known allergy to bovine collagen, bovine gelatin, or other bovine products 25. Known adverse reaction to any bovine product 26. Febrile illness within 7 days 27. Treatment with another investigational drug or other intervention, either concurrently or previously, that would interfere with surgical healing 28. Not considered by treating physician to be a good research candidate EXCLUSION CRITERIA AT INTRAOPERATIVE ARTHROSCOPIC EVALUATION 1. Time from injury to surgery has exceeded 50 days 2. No ACL tear found upon arthroscopic inspection 3. ACL tear found to be only partial, with normal pivot shift and endpoint, and does not require surgery 4. Displaced bucket handle meniscal injury requiring repair 5. Diagnosis of full-thickness chondral injury of Grade 3 or 4, or that requires more than microfracture (i.e., osteochondral autograft transplant), on either condyle 6. Unrecognized lateral or medial sided Grade 3 ligamentous injury that requires concurrent or staged surgery 7. Tibial stump length is \< 1cm 8. Tibial footprint attachment is \< 50% intact 9. Any other reason the ACL stump should be deemed irreparable (e.g., tissue quality too poor to hold suture)

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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

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Ohio State University

    Columbus, Ohio, 43202, United States

  • TRIA Orthopaedics Center/ University of Minnesota

    Bloomington, Minnesota, 55431, United States

  • University Orthopedics Institute/ Rhode Island Hospital

    Providence, Rhode Island, 02906, United States

  • University of Colorado

    Boulder, Colorado, 80309, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

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