A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis
Keywords
Abstract
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 09/05/2019 |
| Estimated Enrollment Submitted: | 09/08/2019 |
| First Posted: | 09/09/2019 |
| Last Update Submitted: | 09/08/2019 |
| Last Update Posted: | 09/09/2019 |
| Actual Study Start Date: | 09/30/2019 |
| Estimated Primary Completion Date: | 09/30/2020 |
| Estimated Study Completion Date: | 01/29/2021 |
Condition or disease
Intervention/treatment
Device: Cingal injection
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: Cingal injection Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 22-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic. | Device: Cingal injection Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 22-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic. |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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, 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. 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 13. HA intra-articular injections into the index hip within the last 6 months before receiving Cingal 14. Corticosteroid therapy by systemic, intra-articular, or intramuscular route or oral corticosteroids within the last 6 months before receiving Cingal 15. Any injection received in the hip prior to receiving or received concurrently with Cingal 16. Uncontrolled diabetes 17. Pregnancy or planning to become pregnant 18. Patient is incarcerated 19. Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities 20. Rheumatoid arthritis or gouty arthritis 21. Current diagnosis of osteomyelitis 22. 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 23. 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) 24. Participation in concurrent trial that involves a medical intervention 25. 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 26. 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. |
Outcome
Primary Outcome Measures
1. Patient reported hip pain as measured by Visual Analog Scale [6 months]
Secondary Outcome Measures
1. Hip Function, as measured by the Hip Outcome Score (HOS) [6 months]
2. Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12) [6 months]
3. Physical activity levels as measured by a wrist-worn activity tracker [6 months]
4. Complications, including infection, reduced range of motion, and other adverse events at 6-months post-injection. [6 months]
