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:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT04084704
Eligibility Criteria:
Inclusion Criteria:
1. Adult men or women ages 40 to 65 years
2. Hip OA (mild to moderate) diagnosed on x-ray and/or MRI (Tonnis grade 1 and 2)
3. Patient is using only nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/ paracetamol (Tylenol) for pain relief during the month before receiving Cingal
4. Patient is willing to stop pain/anti-inflammatory medication at least two weeks prior to receiving Cingal through the end of the study (6 months)
5. Patient speaks, reads, and understands the language of the clinical site
6. Provision of informed consent
Exclusion Criteria:
1. Evidence of hip dysplasia (centre edge angle less than 20 degrees)
2. Presence of advanced hip OA (Tonnis Grade 3)
3. Previous trauma to the affected hip requiring medical or surgical treatment
4. Previous surgery on the affected hip or contralateral hip
5. Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
6. Infections or skin diseases at target hip joint
7. Immunosuppressive medication use
8. Chronic pain syndromes
9. Significant medical co-morbidities (requiring daily assistance for activities of daily living)
10. History of paediatric hip disease (e.g. Legg-Calve-Perthes; slipped capital femoral epiphysis)
11. 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 hip)
12. Known hypersensitivity (allergy) to hyaluronan preparations
13. Known hypersensitivity (allergy) to triamcinolone hexacetonide preparations
14. Known sensitivity to any of the materials in Cingal
15. Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned
16. HA intra-articular injections into the index hip within the last 6 months before receiving Cingal
17. Corticosteroid therapy by systemic, intra-articular, or intramuscular route or oral corticosteroids within the last 6 months before receiving Cingal
18. Any injection received in the hip prior to receiving or received concurrently with Cingal
19. Uncontrolled diabetes
20. Subject is a woman who is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study
21. Patient is incarcerated
22. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
23. Rheumatoid arthritis or gouty arthritis
24. Current diagnosis of osteomyelitis
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. Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin or anti-platelet agents \[e.g. ASA, Plavix\]) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
27. Participation in concurrent trial that involves a medical intervention
28. Patient is currently receiving workman's compensation or disability, has been involved in an motor vehicle accident, or is in litigation for workman's compensation or disability claims
29. Likely problems, in the judgment of the treating physician, with maintaining follow up (e.g. patients with no fixed address, plans to move out of town). This may include patients with severe mental disorders and drug addictions without adequate support.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT04084704
Study Brief:
Protocol Section:
NCT04084704