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Orthosis for treatment of Knee Osteoarthritis

Conditions
osteoarthritis, gonartrose
Registration Number
NL-OMON23870
Lead Sponsor
Department of Orthopedics, Martini Hospital Groningen
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Other
Sex
Not specified
Target Recruitment
10
Inclusion Criteria

• age between 25 and 60 years

• primary unilateral osteoarthritis in the tibiofemoral joint

Exclusion Criteria

• osteoarthritis in both knees

• generalized osteoarthritis (genetic)

Study & Design

Study Type
Not specified
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Secondary outcomes are: <br /><br>- the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy et al. 1988) between all other time-points. <br /><br>- Visual Analogue Scale (VAS) scores for pain (Bijur et al, 2001; Downie et al, 1978) between all time-points.<br /><br>- assessment of articular cartilage volume with MRI (using the GENERIC protocol) between all time-points. <br /><br>- severity of osteoarthritis determined with standardized knee X-rays between all time-points<br>
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