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

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)