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

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO) - Knee joint distraction compared to high tibial osteotomy

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34414
Enrollment
69
Registered
2011-01-26
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

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice Age 2 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

Exclusion criteria

Exclusion criteria: Mechanic axis-deviation of more 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

Design outcomes

Primary

MeasureTime frame
1. Intrinsic cartilage repair, examined as decrease in 'denuded area's of bone', as determined on quantitative MRI in comparison with own baseline values and with HTO.

Secondary

MeasureTime frame
2. Cartilage tissue repair over 2 year follow-up compared to baseline by use of queantitative MRI parameters of the same iamges, X-ray evaluation, and biomarker analyses in blood and urine. 3. Clinical effetiveness determined by a questionnaire for pain, other symptoms, function in daily living, function in sports and recreation, and knee related quality of life (KOOS) and a VAS for pain. 4. Indication of costs-effeciveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)