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Joint distraction in the treatment of severe knee osteoarthritis; optimizing the method.

Joint distraction in the treatment of severe knee osteoarthritis; optimizing the method. - Joint distraction in the treatment of severe knee osteoarthritis

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33996
Enrollment
4
Registered
2009-03-17
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

arthrosis joint degeneration osteoarthritis

Interventions

Patients will be treated with an external fixator bridging the knee joint. Two monotubes are placed on bone pines, four pins in the femur and four in the tibia. The joint is distracted for at least

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 2

Exclusion criteria

Exclusion criteria: Bilateral knee osteoarthritis Joint malalignment > 10° History of infectious arthritis Primarily patello-femoral osteoarthitis Knee instability with physical examination Psychological difficulties which interfer with joint distraction

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter will be clinical effectivity determined by the WOMAC questionair on pain, function and stiffness. Structural effectivity will be analysed on x-ray and MR. The treatment with one month distraction is considered effective if three out of four patients have comparable results with the previous study of two months distraction.

Secondary

MeasureTime frame
A secundary outcome parameter is clinical effectivity based on physical examination. There will also be a more specific analysis on biological change of the joint by biomarker and MR analysis. Pin tract infections will be registered and retrospectively compared to the two month distraction study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)