Comparing a new ACL repair method with traditional reconstruction

BEAR - MOON: A Two Arm Non-Inferiority Randomized Clinical Trial Comparing ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction

This study is testing a new ACL repair method called BEAR to see if it helps active people aged 18-55 heal better than the traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (Boulder, Colorado and 5 other locations)
• Trial ID: NCT03776162 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Bridge-Enhanced ACL Restoration (BEAR) technique, which uses a blood-enriched implant to promote healing of a torn anterior cruciate ligament (ACL). Participants will be randomly assigned to receive either the BEAR procedure or the standard bone-patellar tendon-bone (BPTB) reconstruction. The study aims to assess the outcomes of these two surgical approaches over a two-year follow-up period. Approximately 200 active patients aged 18-55 with complete ACL tears will be included across six medical centers.

Who should consider this trial

Good fit: Ideal candidates are active individuals aged 18-55 who have a complete ACL tear and are undergoing surgery within 50 days of their injury.

Not a fit: Patients with prior ACL surgeries on either knee or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive and more effective option for ACL repair, potentially reducing recovery time and improving outcomes.

How similar studies have performed: Previous studies have shown promise with similar approaches, but the BEAR technique represents a novel method in ACL repair.

Eligibility criteria

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)

Where this trial is running

Boulder, Colorado and 5 other locations

• University of Colorado — Boulder, Colorado, United States (Recruiting)
• TRIA Orthopaedics Center/ University of Minnesota — Bloomington, Minnesota, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• University Orthopedics Institute/ Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Kurt P Spindler, MD — The Cleveland Clinic
• Study coordinator: Carrie B Melgaard, MS

Conditions Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Reconstruction; Anterior Cruciate Ligament Repair; Knee Surgery