A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction

NCT ID: NCT03776162

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2027-12-31

Brief Summary

This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-55 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years.

Detailed Description

The study population will include active and otherwise healthy patients of both genders, all races, and between 18-55 years old at any of six locations, who elect to undergo primary surgery for a torn ACL within 50 days of injury. Approximately 100 patients will receive each of the experimental BEAR surgery and the comparative control BPTB reconstruction surgery, with each group distributed similarly across the six medical centers where the trial is being conducted: Cleveland Clinic, Vanderbilt University, Ohio State University, Rhode Island Hospital/University Orthopedics, and University of Colorado . The study intervention uses a BEAR implant, which is placed between the torn ends of the ruptured ACL. The BEAR implant is resorbed over 4 to 8 weeks, during which period it promotes repair of the ACL tissue in the gap between the torn ends. The device provides a stable provisional sponge to facilitate intra-articular repair of the torn ACL ligament, where without the implant device, healing does not occur. The results of this BEAR procedure will be compared against ACL reconstruction using a BPTB autograft. This technique consists of removing the torn ACL tissue, harvesting patellar tendon, and grafting that tendon within tunnels in the bone to reconstruct or replace the torn ACL. The study duration is five years. Surgery will occur at most 50 days after the patient's ACL is torn, with two year follow-up and a three month window for the final follow-up examination, for a maximum enrollment period for each patient of approximately 2 years and five months (29 months). Randomization will occur during the surgery, and patients will be informed of their treatments at conclusion of their participation. The two research time points are 1 and 2 years, when assessments will be conducted by an independent examiner masked to the type of surgery the patient received. With the exception of the RCT consenting process, use of the BEAR implant, and the blinded assessment process, clinical care will be standard practice following surgical treatment for a torn ACL.

Conditions

Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ACL Reconstruction(BPTB Graft)

Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

Group Type: ACTIVE_COMPARATOR

ACL Reconstruction (Bone Patellar Tendon Bone Graft)

Intervention Type: PROCEDURE

Standard of care procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

Bridge Enhanced ACL Restoration

Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Group Type: EXPERIMENTAL

Bridge Enhanced ACL Restoration (BEAR)

Intervention Type: DEVICE

The BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Interventions

ACL Reconstruction (Bone Patellar Tendon Bone Graft)

Standard of care procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

Intervention Type: PROCEDURE

Bridge Enhanced ACL Restoration (BEAR)

The BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Intervention Type: DEVICE

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

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Miach Orthopaedics

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kurt Spindler, MD

Professor Surgery CCLCM Case Western, Director Research and Outcomes Cleveland Clinic Florida, Director Outcomes Management Evaluation, Co-Director Musculoskeletal Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kurt P Spindler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

University of Colorado

Boulder, Colorado, United States

TRIA Orthopaedics Center/ University of Minnesota

Bloomington, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University Orthopedics Institute/ Rhode Island Hospital

Providence, Rhode Island, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

BEAR-MOON; Vega JF, Strnad GJ, Briskin I, Cox CL, Farrow LD, Fadale P, Flanigan D, Hulstyn M, Imrey PB, Kaeding CC, Owens BD, Saluan P, Wright R, Yen YM, Spindler KP. Interrater Agreement of an Arthroscopic Anterior Cruciate Ligament Tear Classification System. Orthop J Sports Med. 2020 Dec 3;8(12):2325967120966323. doi: 10.1177/2325967120966323. eCollection 2020 Dec.

Reference Type: BACKGROUND

PMID: 33330736 (View on PubMed)

BEAR-MOON Design Group; Spindler KP, Imrey PB, Yalcin S, Beck GJ, Calbrese G, Cox CL, Fadale PD, Farrow L, Fitch R, Flanigan D, Fleming BC, Hulstyn MJ, Jones MH, Kaeding C, Katz JN, Kriz P, Magnussen R, McErlean E, Melgaard C, Owens BD, Saluan P, Strnad G, Winalski CS, Wright R. Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial. Orthop J Sports Med. 2022 Jan 25;10(1):23259671211065447. doi: 10.1177/23259671211065447. eCollection 2022 Jan.

Reference Type: BACKGROUND

PMID: 35097143 (View on PubMed)

Other Identifiers

R01AR074131-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

G180167

Identifier Type: -

Identifier Source: org_study_id