Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04875767
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged 18-40 years
2. Hip pain lasting 6 months or more with no relief from documented non-operative modalities
3. Cam, Pincer, or Mixed FAI
4. 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
5. Focal acetabular articular cartilage lesions measuring between 1x1 cm2 and 5x5 cm2 on MRI and confirmed on arthroscopic examination
6. Patient agrees to participate in the study-specific postoperative rehabilitation protocol
7. Patient can speak, read, and understand the language of the site
8. Patient has provided informed consent
Exclusion Criteria:
1. Cartilage defects of the femoral head
2. Previous surgery on the study hip
3. Traumatic chondral injury of the hip from a single event
4. Presence of advanced osteoarthritis (Tonnis grade 2 or 3)
5. Known hypersensitivity or allergy to hyaluronate
6. Evidence of hip dysplasia (i.e. lateral centre edge angle \< 20˚)
7. Evidence of acetabular over coverage such as coxa profunda or coxa protrusion
8. Immunosuppressive or anti-proliferative medication use
9. Chronic pain syndromes
10. Significant medical co-morbidities (requiring assistance for activities of daily living (ADLs))
11. History of paediatric hip disease
12. Uncontrolled diabetes
13. Contraindications to MRI imaging (e.g. claustrophobia)
14. Patient is involved in ongoing legal or workplace claims
15. Patient is incarcerated
16. Patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04875767
Study Brief:
Protocol Section:
NCT04875767