Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis
- Conditions
- joint degenerationosteoarthritis1002321310005944
- Registration Number
- NL-OMON39144
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Patients considered for TKP according to regular clinical practice
Age < 65 years
Radiological joint damage: Kellgren & Lawrence score 2 or higher
Intact knee ligaments
Normal range-of-motion (min. of 120° flexion; max flexion limitation of 15°)
Normal stability
Body Mass Index < 35
Psychological inabilities or difficult to instruct
Not able to undergo MRI examination according to standard checklists
Inflammatory or rheumatoid arthritis present or in history
Post traumatic fibrosis due to fracture of the tibial plateau
Bone-to-bone contact in the joint (absence of any joint space on X-ray)
Surgical treatment of the involved knee < 6 months ago
An infectious susceptible prosthesis (joint replacement) in situ
Primary patello-femoral osteoarthritis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Clinical effectiveness determined by WOMAC. </p><br>
- Secondary Outcome Measures
Name Time Method <p>2. Clinical effectiveness determined by KOOS.<br /><br>3. Pain evaluated with VAS score.<br /><br>4. Indication of costs-effectiveness.<br /><br>5. Structural repair of cartilage as detemined on X-rays, MRI and biomarker<br /><br>analysis (only in patients treated with KJD) in comparison with own baseline<br /><br>values. </p><br>