Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

Study Overview
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Brief Summary
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This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.

Official Title
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A Double-blind, Randomized, Multi-centre Study of the Efficacy and Safety of a Single Intra-articular Injection With Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

Conditions
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Unilateral Knee Osteoarthritis

Intervention / Treatment
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* Device: Durolane injection
* Other: Saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis according to ACR (American College of Radiology) criteria for the knee WOMAC pain score in the range 7 to 17 Significant knee pain for the majority of days during the past 3 months Patient normally active, not bedridden or confined to a wheelchair and able to walk 50 meters without the help of a walker, crutches or a cane Patient has attempted but not responded adequately to non-pharmacological therapy(ies) Patient co-operative and able to communicate effectively with the investigators Signed informed consent obtained Exclusion Criteria: Bilateral knee osteoarthritis Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee Kellgren Lawrence radiographic score grade IV for the study knee Change in physical therapy/occupational therapy for the knee within the last 3 months Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3 days Intra-articular injection with corticosteroids in the study knee within the last 3 months Use of systemic steroids (excluding inhalation steroids) within the last 3 months Intra-articular injections with hyaluronic acid in the study knee within the last 9 months Treatment with glucosamine/chondroitin sulfate within the last 3 months Treatment with pain relievers except for paracetamol up to 4g/day Treatment with anticoagulant (except for acetylsalicylic acid max. 325 mg/day) Arthroscopy or any other surgical procedure in the study knee within the last 12 months Planned arthroscopy or any other surgical procedure during the study period Any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion (e.g. severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia) Systemic active inflammatory condition or infection, such as Rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/acute pseudogout or any other connective tissue disease Septic arthritis in the study knee within the last 3 months Active skin disease or infection in the area of the injection site Significant venous or lymphatic stasis present in the legs Pregnant or breast-feeding woman or woman of child-bearing potential not practicing adequate contraception Subjects that in the opinion of the investigator are unsuitable for inclusion (e.g. subjects not likely to avoid other therapies, subjects not likely to stay in the study during the whole study period, or subjects likely to be unreliable) Concurrent participation in any other clinical study or participation within the preceding 30 days

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Durolane injection<br>Intraarticular injection of 3 ml Durolane. | Device: Durolane injection<br> <br> |
| Placebo Comparator: Saline injection<br>Intraarticular injection of physiological sodium chloride (0.9% NaCl) solution pH 7. | Other: Saline injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders at 6 weeks. | Proportion of responders was based on the improvement in WOMAC (Western Ontario and McMasters Universities Osteoarthritis Index) pain score. | At 6 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain score |  | 2 and 4 weeks after treatment | 
| Safety of intraarticular injections of 3 ml Durolane | Safety was assessed by adverse event soliciting. | Through 6 weeks after treatment | 
| WOMAC stiffness score |  | 2, 4 and 6 weeks after treatment | 
| WOMAC physical function score |  | 2, 4 and 6 weeks after treatment | 
| Patient assessed global status |  | 2, 4 and 6 weeks after treatment |