degenerative joint disease Osteoarthritis of the knee
Conditions
Interventions
during two months patients use an non-weight bearing orthosis
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • age between 25 and 60 years • primary unilateral osteoarthritis in the tibiofemoral joint • severity of osteoarthritis: moderate to severe (KL2 or higher) but below the level required for joint replacement
Exclusion criteria
Exclusion criteria: • symptomatic osteoarthritis in both knees • generalized osteoarthritis (genetic) • mechanical axis deviations > 10° • psychological problems that would hinder wearing the orthosis • primary retro patellar osteoarthritis • BMI >= 30 • Balance problems (ASA 3 or higher)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy et al. 1988), an osteoarthritis specific questionnaire for pain, stiffness and functioning between pre-intervention and after 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy et al. 1988) between all other time-points. - Visual Analogue Scale (VAS) scores for pain (Bijur et al, 2001; Downie et al, 1978) between all time-points. - assessment of articular cartilage volume with MRI (using the GENERIC protocol) between all time-points. - severity of osteoarthritis determined with standardized knee X-rays between all time-points - Visual Analogue Scale (VAS) score for satisfaction about the treatment result at two year follow-up | — |
Countries
Netherlands
Outcome results
None listed