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

- candidate number9437
- NTR NumberNTR2900
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mei-2011
- Secondary IDs11-072/E METC UMCU
- Public TitleKnee Joint Distraction in comparison with High Tibial Osteotomy in treatment of knee osteoarthritis.
- Scientific TitleJoint distraction in treatment of knee osteoarthritis: A comparison with a presently applied surgical alternative, high tibial osteotomy.
- hypothesisDenuded bone areas are filled up with cartilage (determined with quantitative MRI) which is not anticipated to occur in case of HTO. The cartilage changes are compared two years post treatment.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Knee
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate1-mei-2014
- Target number of participants69
- InterventionsKnee 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 distracted 2mm. During hospitalisation the frame is further distracted, 1mm a day, until in total 5mm is reached. Distraction lasts for 6 weeks whereby fully load bearing is encouraged, with crutches for stability. After 6 weeks the frame is removed at day-care surgery.
High Tibial Osteotomy is performed as usual according to the clinical protocol.
- Primary outcomeCartilage changes determined by decrease in denuded bone areas using quantitative MRI analyses.
- Secondary outcome1. 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.
- TimepointsBaseline (2x), 3 and 6 weeks, 3, 6, 9, 12, 18, and 24 months follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThis, multi-center, randomised controlled, non-blinded prospective 2 years follow-up trial will be accomplished at the Maartenskliniek Woerden (MK-W) in collaboration with the University Medical Center Utrecht (UMCU). Patients with severe OA of the knee whom are indicated for a high tibial osteotomy by a orthopaedic surgeon and meet the inclusion criteria are asked to participate. When included, patients will be randomised between High Tibial Osteotomy and Knee Joint Distraction (2:1). All patients will be monitored for tissue structure changes which will be evaluated over time up to two years. Quantitative MRI images and X-rays are analyzed for cartilage changes. Blood and urine will be collected before and up to 2 years after surgery. Samples are used for evaluation of biochemical markers of cartilage and bone synthesis and breakdown. Moreover, clinical outcome parameters and data on direct and indirect costs as well as change in quality of life are gathered by use of questionnaires.
- Main changes (audit trail)
- RECORD16-mei-2011 - 24-mei-2011

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