A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis

NCT04084704 | Completed

• 1 other identifier: 7692
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Patient reported hip pain as measured by Visual Analog Scale

  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.

  6 months

Secondary Outcomes (5)

• Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS)

  6 months

• Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)

  6 months

• Physical activity levels as measured by a wrist-worn activity tracker

  6 months

• Complications, including infection and other adverse events at 6-months post-injection.

  6 months

• Range of motion

  6 months

Study Arms (1)

Cingal injection

OTHER

Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic.

Device: Cingal

Interventions

Cingal DEVICE

Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic.

Cingal injection

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)
• Known hypersensitivity (allergy) to hyaluronan preparations
• Known hypersensitivity (allergy) to triamcinolone hexacetonide preparations
• Known sensitivity to any of the materials in Cingal
• Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned

Sponsors & Collaborators

• McMaster University: lead
• Anika Therapeutics, Inc.: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: September 1, 2020
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)