Joint distraction (KJD) in treatment of knee osteoarthritis: cartilage changes in a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

Phase 3

Completed

Conditions: 10023213
10005944
joint degeneration
osteoarthritis

Registration Number: NL-OMON39482

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 69

Inclusion Criteria

Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice,
Age < 65 years,
Radiological joint damage: Kellgren & Lawrence score 2 or higher
Intact knee ligaments
Normal range-of-motion,
normal stability
Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
Body Mass Index < 35

Exclusion Criteria

Mechanic axis-deviation of less than 10 degrees
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
Contra-lateral knee OA that needs treatment
Primary patello-femoral osteoarthritis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Cartilage changes determined by decrease in area of denuded bone using<br /><br>quantitative MRI analyses (according to Eckstein) at 2 years (blinded<br /><br>evaluation). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Cartilage changes determined by X-rays (joint space width using KIDA),<br /><br>additional quantitative MRI parameters (Eckstein), and biochemical markers<br /><br>analyses (blinded evaluation).<br /><br>- Clinical efficacy over time by self assessed questionnaire (KOOS score for<br /><br>pain, other symptoms, function in daily living, function in sports and<br /><br>recreation, and knee related quality of life) and VAS for pain (non-blinded).<br /><br>- Medical consumption and non-medical costs related to disease and treatment<br /><br>are estimated by a questionnaire (custom made). Quality of life is evaluated by<br /><br>questionnaires (EQ-5D) (non-blinded). </p><br>