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

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)