NL-OMON39144
Completed
Phase 3
Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis - Knee joint distraction compared to total knee prosthesis
niversitair Medisch Centrum Utrecht0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- joint degeneration
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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