Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives.

Phase 3

Withdrawn

• Conditions: joint degeneration; osteoarthritis; 10003816; 10023213; 10005944

• Registration Number: NL-OMON34828
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 152

Inclusion Criteria

Cohort A:
* Patients considered for HTO according to regular clinical practice
* Age < 65 years
* Radiological joint damage: Kellgren & Lawrence score > 2 (*2: mild but definite osteophyte formation, with essentially normal joint space width*)
* Normal range-of-motion, normal stability
* Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
* Mechanic axis-deviation 5-10 degrees
* Non smoking
* Body Mass Index < 35;Cohort B:
* Patients considered for TKP according to regular clinical practice
* Age < 65 years
* Radiological joint damage: Kellgren & Lawrence score *2 (*2: mild but definite osteophyte formation, with essentially normal joint space width*)
* Intact knee ligaments
* Normal range-of-motion, normal stability
* Maximum flexion limitation of 15 degrees (minimum of 120 degrees flexion pre-operative)
* Non smoking
* Body Mass Index < 35;Cohort C:
* Patients considered for KReS according to regular clinical practice
* First revision of a TKP
* The original TKP placement under the inclusion criteria as defined for cohort B

Exclusion Criteria

For cohorts A and B:
* Psychological inabilities or difficult to instruct
* Claustrofoby and therefore fear of MRI examination
* Inflammatory or rheumatoid arthritis present or in history
* Bone-to-bone contact in the joint (absence of a joint space on X-ray)
* Surgical treatment of the involved knee < 6 months ago
* Primary patello-femoral osteoarthritis;For cohorts C:
* Placement of the original TKP under the exclusion criteria as defined for cohort B.

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. Structural repair of cartilage as detemined on X-rays and MRI (only in<br /><br>patients treated with KJD and HTO).<br /><br>3. Costs -effectiveness measured using long-term (life-long) medical and<br /><br>non-medical costs and Quality Adjusted Life Years as calculated, using the<br /><br>health economic model</p><br>