The Efficacy of Viscosupplementation for Early Knee Osteoarthritis | Recruiting
The Efficacy of Viscosupplementation for Early Knee Osteoarthritis
EVOKE
Trial Source

Health Conditions
  • Knee Osteoarthritis
Recruiting
Recruitment Status
NCT01210742
Primary Trial ID Number
Summary
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 groupsÍž 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.
Primary Outcome Measures
  • Walking pain; 6 months
Secondary Outcome Measures
  • Patient satisfaction; 6 months
Research Question
  • 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 groupsÍž 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 70 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
60
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - 18-70 years
  • - Radiographic evidence of OA in the tibiofemoral compartment (minute or definite
  • osteophytes and a measurable joint space)
  • - Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.
  • - Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)
  • - Pain score of 1, 2 or 3 on Q1 (pain) of OKS.
  • - Suitable for viscosupplementation
  • Exclusion Criteria:
  • - OKS of below 12 and above 36 (0-48, 48 no problem)
  • - Pain score of 0 or 4 on Q1 (pain) of OKS.
  • - Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).
  • - Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).
  • - A clinically apparent tense effusion of the target knee.
  • - Significant valgus/varus deformities.
  • - Ligamentous laxity or meniscal instability.
  • - Viscosupplementation history in any joint in the past 9 months.
  • - Previous surgery at the target knee in the past 6 months.
  • - Concomitant inflammatory disease (rheumatoid arthritis) or other condition that
  • affects the joints.
  • - Use of prohibited medication/treatment for chronic pain.
  • - Pregnancy or new mothers who are breastfeeding.
  • - Systemic or intra-articular injection of corticosteroids in any joint within 3 months
  • prior to screening.
  • - Obvious cartilage defects producing mechanical symptoms (i.e. locking).
  • - Listed for a knee replacement procedure for osteoarthritis of the knee.
  • - Have a history of failed conservative treatment (exercise therapy, physiotherapy).
Participant Exclusion Criteria
  • Inclusion Criteria:
  • - 18-70 years
  • - Radiographic evidence of OA in the tibiofemoral compartment (minute or definite
  • osteophytes and a measurable joint space)
  • - Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.
  • - Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)
  • - Pain score of 1, 2 or 3 on Q1 (pain) of OKS.
  • - Suitable for viscosupplementation
  • Exclusion Criteria:
  • - OKS of below 12 and above 36 (0-48, 48 no problem)
  • - Pain score of 0 or 4 on Q1 (pain) of OKS.
  • - Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).
  • - Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).
  • - A clinically apparent tense effusion of the target knee.
  • - Significant valgus/varus deformities.
  • - Ligamentous laxity or meniscal instability.
  • - Viscosupplementation history in any joint in the past 9 months.
  • - Previous surgery at the target knee in the past 6 months.
  • - Concomitant inflammatory disease (rheumatoid arthritis) or other condition that
  • affects the joints.
  • - Use of prohibited medication/treatment for chronic pain.
  • - Pregnancy or new mothers who are breastfeeding.
  • - Systemic or intra-articular injection of corticosteroids in any joint within 3 months
  • prior to screening.
  • - Obvious cartilage defects producing mechanical symptoms (i.e. locking).
  • - Listed for a knee replacement procedure for osteoarthritis of the knee.
  • - Have a history of failed conservative treatment (exercise therapy, physiotherapy).
Interventions
Device; Synvisc One; Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline; [Viscosupplementation with routine management]; Other; Routine management; Routine non-operative management for knee OA (NICE guidelines); [Routine management]
Design Details
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Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
EVOKE
Scientific Title
The Efficacy of Hylan G-F 20 (Synvisc One) Injections in the Routine Management of Patients With Early Osteoarthritis of the Knee -a Randomised Controlled Trial (Pilot)
Secondary Trial Identifying Number
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Website
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Study Funded By
University of Oxford
Funder Type
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Study Sponsored By
University of Oxford
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

24 Sep 2010

Last Updated

15 Jun 2012

Date Record Refreshed on UKCTG

24 Jul 2015