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

The study population will include active and otherwise healthy patients of both genders, all
races, and between 18-40 years old at any of five 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 five medical centers where the trial is
being conducted: Cleveland Clinic, Vanderbilt University, Ohio State University, Rhode Island
Hospital/University Orthopedics, and Washington University in St. Louis. The study
intervention uses a BEAR Implanted scaffold, which is placed between the torn ends of the
ruptured ACL. The BEAR scaffold 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 scaffold 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.

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the
following criteria:

1. 18-40 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 surgery on affected or unaffected knee

2. Confirmed or suspected contralateral ACL tear

3. ACL tear found to be only partial and the treating physician feels it does not require
surgery because it is "stable"

4. 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

5. Diagnosis of Grade 3 medial collateral injury that requires concurrent or staged
surgery

6. Insufficient ACL tissue on MRI

7. Diagnosis of complete patellar dislocation

8. Diagnosis of complete patellar tendon or quadriceps tear

9. Obesity with a BMI ≥35

10. Does not speak or understand English

11. History of regular tobacco or nicotine use in any form

12. History of drug or alcohol abuse

13. Inability to take oral medications

14. Use of intra-articular corticosteroids in the affected knee within last 6 months

15. Chronic use of oral corticosteroids (e.g., to treat lupus, rheumatoid arthritis,
asthma, etc.)

16. History of prior infection in knee

17. History of chemotherapy treatment

18. History of sickle cell disease

19. History of anaphylaxis

20. Any condition that, in the opinion of the investigator, could affect healing (e.g.,
diabetes, inflammatory arthritis, etc.)

21. Pregnancy or lactation

22. Known allergic reactions to meat products or collagen

23. Known allergy to bovine collagen, bovine gelatin, or other bovine products

24. Known adverse reaction to any bovine product

25. Febrile illness within 7 days

26. Treatment with another investigational drug or other intervention, either concurrently
or previously, that would interfere with surgical healing

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)