Status:
UNKNOWN
The Efficacy of Viscosupplementation for Early Knee Osteoarthritis
Lead Sponsor:
University of Oxford
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01210742
Start Date
May 1 2011
End Date
October 1 2013
Last Update
June 18 2012
Active Locations (1)
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1
Nuffield Orthopaedic Centre, Biomedical Research Unit (BRU)
Oxford, England, United Kingdom, OX3 7LD