Feasibility study of an orthosis for treatment of Knee Osteoarthritis

Completed

Conditions: degenerative joint disease
Osteoarthritis of the knee
10023213

Registration Number: NL-OMON47115

Lead Sponsor: Martini Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

• 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the Western Ontario and McMaster Universities<br /><br>Osteoarthritis (WOMAC) (Bellamy et al. 1988), an osteoarthritis specific<br /><br>questionnaire for pain, stiffness and functioning between pre-intervention and<br /><br>after 24 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (Bellamy<br /><br>et al. 1988) between all other time-points.<br /><br>- Visual Analogue Scale (VAS) scores for pain (Bijur et al, 2001; Downie et al,<br /><br>1978) between all time-points.<br /><br>- assessment of articular cartilage volume with MRI (using the GENERIC<br /><br>protocol) between all time-points.<br /><br>- severity of osteoarthritis determined with standardized knee X-rays between<br /><br>all time-points<br /><br>- Visual Analogue Scale (VAS) score for satisfaction about the treatment result<br /><br>at two year follow-up</p><br>