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Closing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus Tomofix plate fixation. A randomised trial.


- candidate number1692
- NTR NumberNTR483
- ISRCTNISRCTN32133423
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDs
- Public TitleClosing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus Tomofix plate fixation. A randomised trial.
- Scientific TitleClosing wedge high tibial osteotomy for unicompartmental knee osteoarthritis: staples and cast fixation versus Tomofix plate fixation. A randomised trial.
- ACRONYMclosing HTO
- hypothesisClosing wedge osteotomy with plate fixation only will result in earlier mobilisation and better one year results considering pain and function then staple and cast fixation.
- Healt Condition(s) or Problem(s) studiedArthritis, Osteoarthritis
- Inclusion criteria1. Patients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty;
2. Above 18 years of age;
3. Patient is knowledgeable and able to understand the treatment consequences;
4. Informed consent.
- Exclusion criteria1. Mechanical axis not through the medial compartment (HipKneeAnkle angle > 180вк);
2. Rheumatoid arthritis;
3. HipKneeAnkle angle < 169им;
4. ROM < 100вк;
5. Extension deficit 15им;
6. Collateral ligament insufficiency (instability grade 3);
7. Indication for a supracondylar femur osteotomy;
8. Not able to speak or understand Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2004
- planned closingdate31-dec-2007
- Target number of participants92
- InterventionsClosing wedge high tibial osteotomy.
- Primary outcomeIs the accuracy of achieved correction of the mechanical limb axis postoperatively compared to the preoperatively planned correction superior for closing wedge HTO with plate fixation?

Measurement:
1. Conservation of corrected angular limb deformity one year after surgery (success rate (%)). (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).
- Secondary outcomeI- Does the functional outcome differ between the two bone defect implants?

Measurement:
1. Knee range of motion (ROM);
2. Pain score (Visual Analogue Scale);
3. Hospital for Special Surgery (HHS) Knee Service Rating System;
4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC);
5. Health related quality-of-life score (EuroQol);
6. Complication.

II - Which surgical technique is most efficient?
Measurement:
7. Cost efficiency.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD T.M. Raaij, van
- CONTACT for SCIENTIFIC QUERIESPhD T.M. Raaij, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsHigh tibia osteotomy for osteoarthritis of the knee: a prospective randomized trial
Reinoud W. Brouwer (MD) , Sita M.A. Bierma-Zeinstra (PhD) , Tom M. van Raaij (MD), Jan A.N. Verhaar (PhD) [submitted]
Patella height and inclination of tibial plateau after High Tibial Osteotomy. The open versus the closed wedge technique. A randomised trial.
Reinoud W. Brouwer (MD), Sita M.A. Bierma-Zeinstra (PhD), Abram J. van Koeveringe (PhD), Jan A.N. Verhaar (PhD) [J Bone Joint Surg Br. 2005 Sep;87(9):1227-32]
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-sep-2005 - 1-feb-2010


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