An interventional study of Synvisc One and Routine management in Knee Osteoarthritis, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-06-18.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
Treatment for early osteoarthritis (OA) of the knee is an increasing problem yet much of the research into OA, to date, concentrates on predisposition, genetic and cellular aspects and the treatment of late stage disease (arthroplasty). Clinicians reviewing patients with early OA have great difficulty in recommending an appropriate and efficacious intervention.
The first line of treatment for patients with early OA is exercise, self-management and weight loss. These tools are suggested to minimize the need for higher risk treatments such as non-steroidal antiinflammatory drugs (NSAIDs) and surgery. Viscosupplementation using intra-articular injections of hyaluronan (Synvisc One) is a relatively new treatment. To date, the ideal patient for viscosupplementation has yet to be defined. It is not known whether incorporation of viscosupplementation into the overall clinical management will have beneficial influence for patients with early OA of the knee.
This study will generate rigorous pilot data to assess the need and inform a larger randomized controlled trial (RCT) assessing the efficacy of viscosupplementation. The study will be a single blind randomised RCT. 60 patients with documented early OA will be randomised into one of two groups; Group V will undergo "one shot" viscosupplementation using Synvisc One in addition to routine physiotherapy management for knee OA. Group No V (control) will have no viscosupplementation but will undergo similar routine management including physiotherapy management for knee OA. Outcome measures will include walking pain (The Western Ontario and McMaster Universities Arthritis Index-WOMAC), the overall WOMAC score, Oxford Knee Score (OKS), American Knee Society score (AKS), complications, activity level and patient satisfaction. Health economics will also be evaluated. Measurements will be recorded pre-intervention and at six months following treatment.
The risks associated with viscosupplementation are minimal. Considering the limited resources currently available in health care, if the latter is shown to have higher effectiveness than physiotherapy alone, in addition to patient benefit, there will be important health economic implications.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
Device: Synvisc One
Routine management for knee OA (NICE guidelines)
Other: Routine management
Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline
Routine non-operative management for knee OA (NICE guidelines)
Walking pain
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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University of Oxford