FindTrial
Sign In

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

Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives. - Knee Joint Distraction compared to osteotomy and total knee prosthesis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34828
Enrollment
152
Registered
2010-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

joint degeneration osteoarthritis

Interventions

KJD is performed according to the methodology as used in previous knee distraction studies, using 2 monotubes, one laterally and one medially. Intra-operative the tubes are distracted 2 mm. During h

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cohort A: * Patients considered for HTO according to regular clinical practice * Age 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Clinical effectiveness determined by WOMAC.—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)