Status:
WITHDRAWN
Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Bone Marrow Aspirate Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Lead Sponsor:
McMaster University
Conditions:
Femoroacetabular Impingement
Cartilage Damage
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Femoroacetabular impingement (FAI) is a hip disorder resulting from a mismatch of the hip joint, resulting in hip pain and can potentially cause osteoarthritis. As the head of the femur (ball of the h...
Eligibility Criteria
Inclusion
- Male and female patients aged 18-40 years
- Hip pain lasting 6 months or more with no relief from documented non-operative modalities
- Cam, Pincer, or Mixed FAI
- Focal articular cartilage defects of the acetabulum on MRI, confirmed to be full thickness (International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 3 or 4) during arthroscopic examination
- Focal acetabular articular cartilage lesions measuring between 1x1 cm2 and 5x5 cm2 on MRI and confirmed on arthroscopic examination
- Patient agrees to participate in the study-specific postoperative rehabilitation protocol
- Patient can speak, read, and understand the language of the site
- Patient has provided informed consent
Exclusion
- Cartilage defects of the femoral head
- Previous surgery on the study hip
- Traumatic chondral injury of the hip from a single event
- Presence of advanced osteoarthritis (Tonnis grade 2 or 3)
- Known hypersensitivity or allergy to hyaluronate
- Evidence of hip dysplasia (i.e. lateral centre edge angle \< 20˚)
- Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
- Immunosuppressive or anti-proliferative medication use
- Chronic pain syndromes
- Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
- History of paediatric hip disease
- Uncontrolled diabetes
- Contraindications to MRI imaging (e.g. claustrophobia)
- Patient is involved in ongoing legal or workplace claims
- Patient is incarcerated
- Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
Key Trial Info
Start Date :
January 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04875767
Start Date
January 3 2023
End Date
November 19 2024
Last Update
November 21 2024
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