A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis

Overview

Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed world. Because OA gradually worsens over time, the sooner treatment is started, the more likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration, and an increase in disability. Multiple treatments are used to manage the degenerating hip as well as the associated pain. These include physiotherapy and rehabilitation, bracing, other walking aids, oral medications, injections, and in severe cases, surgery. Prior research has shown that injection of hyaluronic acid (HA) and corticosteroids can slow down OA degradation. This study will look at the effects of injecting Cingal into the hip, which expands on its current approved use in the treatment of knee OA.

Full Title of Study: “A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (ECHO Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2020

Interventions

  • Device: Cingal
    • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Patient reported hip pain as measured by Visual Analog Scale
    • Time Frame: 6 months
    • The primary objective of this observational study is to determine, among individuals with hip OA ages 40-65 years, the effect of Cingal on patient-reported hip pain, as measured by a Visual Analogue Scale (VAS), at 6-months post-injection.

Secondary Measures

  • Hip Function, as measured by the Hip Outcome Score (HOS)
    • Time Frame: 6 months
    • The HOS is a 26 item questionnaire assessing activities of daily living that are scored on a 5 point Likert scale. Scores range from 0% (least function) to 100% (most function)
  • Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)
    • Time Frame: 6 months
    • The SF-12 may be self or interview-administered and can help document mental and physical components of quality of life. Points can range from 0-100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
  • Physical activity levels as measured by a wrist-worn activity tracker
    • Time Frame: 6 months
  • Complications, including infection, reduced range of motion, and other adverse events at 6-months post-injection.
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Collaborator
    • Anika Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Olufemi Ayeni, Principal Investigator – McMaster University

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