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

Launched by THE CLEVELAND CLINIC · Dec 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical method called bridge-enhanced ACL restoration (BEAR) to repair torn anterior cruciate ligaments (ACLs) in the knee. The BEAR technique uses a special sponge that helps the torn ends of the ligament grow back together, while the standard method, known as autograft patellar tendon reconstruction, involves taking tendon tissue from the patient's knee to replace the torn ACL. The trial aims to see if the BEAR method works as well as the standard technique, but with less invasive surgery.

To be eligible for the trial, participants should be aged 18 to 55 and have a complete ACL tear confirmed by an MRI. They must also be planning to undergo surgery within 50 days of their injury. Participants will be randomly assigned to receive either the BEAR treatment or the standard reconstruction and will follow a specific rehabilitation plan after surgery. Over the next two years, researchers will monitor how well their knees are healing and how they feel about their recovery. This trial is important because it could lead to less invasive options for ACL repair, which could improve recovery and potentially reduce the risk of developing arthritis later on.

Gender

ALL

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)