HyaloFAST Trial for Repair of Articular Cartilage in the Knee

Launched by ANIKA THERAPEUTICS, INC. · Jan 15, 2016

Keywords

ClinConnect Summary

The HyaloFAST Trial is researching a new treatment for knee cartilage damage. This study compares two methods: one uses a special scaffold called Hyalofast® along with a concentration of bone marrow (which contains healthy cells that can help healing), while the other method is known as microfracture, a common procedure for repairing cartilage. The goal is to see which method is safer and more effective for people who have painful cartilage defects in their knees.

To participate in this trial, individuals must be between 18 and 60 years old and have a specific type of knee cartilage damage that causes pain. Participants will need to agree to follow a rehabilitation program after their treatment. It's essential that they have not used certain pain medications before joining the trial and that they meet several health criteria. Those who join can expect regular check-ups and will be monitored closely to assess their recovery and pain management over time. This trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is male or female, between 18 and 60 years of age
• • 2. Patient's body mass index (BMI) is \<35 kg/m2
• • 3. Patient has a symptomatic lesion of the femoral condyle (medial and/or lateral) or femoral trochlea that is between 1.5 - 6 cm2 on screening images confirmed by the independent radiologist
• • 4. The symptomatic lesion is classified as International Cartilage Repair Society (ICRS) grade 3 or 4
• • 5. Patient agrees to actively participate in a strict rehabilitation protocol and follow-up program
• • 6. Patient is using only nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol during the month before signing the informed consent form to treat knee pain
• • 7. Patient is willing and able to provide informed consent and comply with study requirements
• • 8. Patient, if woman of childbearing potential, must have a negative pregnancy test at Screening, cannot be lactating and is willing to use adequate contraception for the first 12 months of the study after the last surgery
• • 9. Patient has ability to consistently rate knee pain and function as demonstrated by completion of total KOOS score
• • 10. Patient has a minimum of 45 out of 100 Visual Analogue Scale (VAS) score for index knee pain when remembering index knee pain when not on medication and when active
• • 11. Patient is willing to use other pain medication rather than Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 6 months post-surgery (e.g. acetaminophen, or narcotic analgesics, if prescribed). Post-surgical use of aspirin for clot prevention is acceptable.
• • 12. Patient is willing to restrict pain medication after 6 months post-surgery to NSAIDs or acetaminophen/paracetamol only through the end of the trial
• • 13. Patient must have Hematocrit ≥ 28.0%; White Blood Cell count ≤ 14,000; Platelet Count ≥ 50,000; Creatinine ≤ 2.0 mg/dL; and International Normalized Ratio (INR) ≤ 1.6
• Exclusion Criteria:
• • 1. Major concomitant cartilage lesions which require extensive surgical treatment. (Lesions such as minor loose bodies, small debris fragments, small cartilage fragments or prominent knee fat pad are allowed. These lesions may be treated with debridement).
• • 2. Presence of a kissing bipolar lesion that is apposed to the index lesion and is deeper than Grade 2 (ICRS classification) as determined by MRI. (Presence of a kissing (bipolar) lesion that is apposed to the index lesion and is deeper than Grade 2 and is discovered under arthroscopy are allowed). The non-index lesion, if indicated for treatment, should be treated with the study assigned treatment of the index lesion.
• • 3. Diagnosed advanced osteoarthritis as demonstrated by a Kellgren-Lawrence grade of 3 or 4 in the index knee
• • 4. Complex ligamentous instability of the index or contralateral knee. (Previous reconstructions of Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) are allowed, of either the index or contralateral knee, if instability is not present. Grade 1 ligamentous injury are allowed)
• • 5. Infections or skin diseases at target knee joint
• • 6. Osteochondritis dissecans (OCD)
• • 7. Patients requiring meniscal arrow or meniscal sutures
• • 8. Previous meniscal transplant in the index knee
• • 9. Patients with previous total or functional meniscectomy. (Patients with a previous partial meniscectomy and a meniscus that is considered biomechanically functional are allowed)
• • 10. Varus or valgus malalignment exceeding 10° in either knee
• • 11. Patient requiring concomitant surgical procedures at the time of Index Procedure such as osteotomies (e.g. high tibial valgus and/or patellar realignment osteotomy), bone subchondral perforation, ligament surgery, meniscal surgeries etc.
• • 12. Previous cartilage repair procedure (microfracture, Osteochondral autograft transplantation system (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee
• • 13. Previous failed microfracture procedure in index knee. (Previous history of microfracture in the contralateral knee is allowed)
• • 14. Known hypersensitivity (allergy) to hyaluronate
• • 15. Contraindication(s) to microfracture surgery
• • 16. Hyaluronic acid intra-articular injections into the index knee within the last 90 days before signing informed consent
• • 17. Corticosteroid therapy by systemic or intra-articular route within the last 60 days before informed consent or intramuscular or oral corticosteroids within the last 30 days before informed consent.
• • 18. Uncontrolled diabetes
• • 19. Any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with evaluation of the index knee
• • 20. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
• • 21. Any evidence of the following diseases in the index knee: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget disease of bone; ochronosis; acromegaly; hemochromatosis; Wilson disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
• • 22. Rheumatoid arthritis or gouty arthritis
• • 23. Current diagnosis of osteomyelitis
• • 24. Any result from screening blood work (including complete blood count, Prothrombin Time (PT)/Partial Thromboplastin Time (PTT)/INR, liver function, and creatinine) that exceeds 1.5x the upper limit of normal or is below 0.5x the lower limit of normal.
• • 25. Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
• • 26. Alcohol and drug (including medication) abuse
• • 27. Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
• • 28. Contraindications to MR imaging
• • 29. Patient is currently receiving workman's compensation or disability or is in litigation for workman's compensation or disability claims
• • 30. Participation in concurrent trials or in previous trial within 90 days of signing informed consent