Knee Joint Distraction in comparison with Total Knee Prosthesis in treatment of knee osteoarthritis.
Recruiting
- Conditions
- Osteoarthritis of the knee.
- Registration Number
- NL-OMON26791
- Lead Sponsor
- niversital Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients considered for TKP according to regular clinical practice;
2. Age < 65 years;
Exclusion Criteria
1. Psychological inabilities or difficult to instruct;
2. Not able to undergo MRI examination (standard protocol);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical effectiveness determined by WOMAC at two years.
- Secondary Outcome Measures
Name Time Method 1. Clinical effectiveness determined by KOOS;<br /><br>2. Pain evaluated with VAS score;<br /><br>3. Indication of cost-effectiveness;<br /><br>4. Structural repair of cartilage as determined on X-rays, MRI and biomarker analysis (only in patients treated with KJD) in comparison with own baseline values.