The Efficacy of Viscosupplementation for Early Knee Osteoarthritis

NCT ID: NCT01210742

Last Updated: 2012-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-10-31

Brief 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 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Viscosupplementation with routine management

Group Type: EXPERIMENTAL

Synvisc One

Intervention Type: DEVICE

Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline

Routine management

Routine management for knee OA (NICE guidelines)

Group Type: ACTIVE_COMPARATOR

Routine management

Intervention Type: OTHER

Routine non-operative management for knee OA (NICE guidelines)

Interventions

Synvisc One

Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline

Intervention Type: DEVICE

Routine management

Routine non-operative management for knee OA (NICE guidelines)

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Beard, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Nuffield Orthopaedic Centre, Biomedical Research Unit (BRU)

Oxford, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Kristina Knezevic

Role: CONTACT

kristina.knezevic@ndorms.ox.ac.uk

+44 (0) 1865 227617

Facility Contacts

Kristina Knezevic

Role: primary

kristina.knezevic@ndorms.ox.ac.uk

Other Identifiers

10/H0604/33

Identifier Type: -

Identifier Source: org_study_id