A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (ECHO Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- McMaster University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Patient reported hip pain as measured by Visual Analog Scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Olufemi Ayeni
Principal Investigator
McMaster University
Eligibility Criteria
Inclusion Criteria
- •Adult men or women ages 40 to 65 years
- •Hip OA (mild to moderate) diagnosed on x-ray and/or MRI (Tonnis grade 1 and 2)
- •Patient is using only nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/ paracetamol (Tylenol) for pain relief during the month before receiving Cingal
- •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)
- •Patient speaks, reads, and understands the language of the clinical site
- •Provision of informed consent
Exclusion Criteria
- •Evidence of hip dysplasia (centre edge angle less than 20 degrees)
- •Presence of advanced hip OA (Tonnis Grade 3)
- •Previous trauma to the affected hip requiring medical or surgical treatment
- •Previous surgery on the affected hip or contralateral hip
- •Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
- •Infections or skin diseases at target hip joint
- •Immunosuppressive medication use
- •Chronic pain syndromes
- •Significant medical co-morbidities (requiring daily assistance for activities of daily living)
- •History of paediatric hip disease (e.g. Legg-Calve-Perthes; slipped capital femoral epiphysis)
Outcomes
Primary Outcomes
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 Outcomes
- Physical activity levels as measured by a wrist-worn activity tracker(6 months)
- Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)(6 months)
- Complications, including infection and other adverse events at 6-months post-injection.(6 months)
- Range of motion(6 months)
- Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS)(6 months)