The Efficacy of Viscosupplementation for Early Knee Osteoarthritis (EVOKE)

June 15, 2012 updated by: University of Oxford

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Viscosupplementation with routine management
Device: Synvisc One
Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline
Active Comparator: Routine management
Routine management for knee OA (NICE guidelines)
Other: Routine management
Routine non-operative management for knee OA (NICE guidelines)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walking pain
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: David J Beard, DPhil, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 27, 2010

First Posted (Estimate)

September 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/H0604/33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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