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| Name | Class |
|---|---|
| Anika Therapeutics, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS) | The HOOS was designed to assess patient opinions about their hip and associated problems in an adult population with a hip disability with or without OA. The HOOS has been extensively validated and consists of 5 subscales for pain, other symptoms, function in activities of daily living, function in sports and recreation, and hip-related quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N3Z5 | Canada |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6 months |
| Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12) | 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. | 6 months |
| Physical activity levels as measured by a wrist-worn activity tracker | To be worn for one week prior to each follow-up visit. | 6 months |
| Complications, including infection and other adverse events at 6-months post-injection. | Adverse events | 6 months |
| Range of motion | ROM will be measured with standard anterior and posterior impingement tests, the log roll test, and hip flexion/extension, abduction/adduction, and internal/external rotation. | 6 months |
| D012216 |
| Rheumatic Diseases |