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Knee Joint Distraction in comparison with High Tibial Osteotomy in treatment of knee osteoarthritis.

Joint distraction in treatment of knee osteoarthritis: A comparison with a presently applied surgical alternative, high tibial osteotomy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25422
Enrollment
69
Registered
2011-05-16
Start date
2011-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Osteoarthritis, Knee

Interventions

Knee Joint Distraction 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 distract

Sponsors

University Medical Center Utrecht (UMCU)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice; 2. Age < 65 years; 3. Radiological joint damage: Kellgren & Lawrence score above 2; 4. Intact knee ligaments; 5. Normal range-of-motion (min. of 120° flexion); 6. Normal stability; 7. Body Mass Index < 35.

Exclusion criteria

Exclusion criteria: 1. Mechanic axis-deviation (varus-valgus) of less than 10 degrees; 2. Psychological inabilities or difficult to instruct; 3. Not able to undergo MRI examination (standard daily clinical practice protocol); 4. Inflammatory or rheumatoid arthritis present or in history; 5. Post traumatic fibrosis due to fracture of the tibial plateau; 6. Bone-to-bone contact in the joint (absence of any joint space on X-ray); 7. Surgical treatment of the involved knee < 6 months ago; 8. Contra-lateral knee OA that needs treatment; 9. Primary patello-femoral OA.

Design outcomes

Primary

MeasureTime frame
Cartilage changes determined by decrease in denuded bone areas using quantitative MRI analyses.

Secondary

MeasureTime frame
1. Cartilage changes determined by X-rays, additional quantitative MRI parameters and biomarker analyses; 2. Clinical effectiveness determined by KOOS questionnaire; 3. Pain evaluated with VAS score; 4. Indication of cost-effectiveness.

Contacts

Public ContactK. Wiegant

Heidelberglaan 100

k.wiegant@umcutrecht.nl+31 (0)88 7559428

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)