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Demineralized bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis.


- candidate number1669
- NTR NumberNTR478
- ISRCTNISRCTN76261748
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDs
- Public TitleDemineralized bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis.
- Scientific TitleDemineralized bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis.
- ACRONYMN/A
- hypothesisOpening wedge HTO treated with DBM will better match one year post-operative mechanical axis alignement with pre-operative planned correction then opening wedeg HTO filled with autogenous iliac crest bone.
- Healt Condition(s) or Problem(s) studiedArthritis, Osteoarthritis
- Inclusion criteriaPatients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty are included.
- Exclusion criteriaExclusion criteria are below 18 years of age, symptoms not related to medial osteoarthritis of the knee or not able to speak or understand Dutch.
Patients will be included after informed consent given and baseline measurements made.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2005
- planned closingdate31-dec-2007
- Target number of participants80
- InterventionsA valgus high tibia opening wedge osteotomy will be performed and the osseous defect will be filled with DBM or autogenous bone graft.
- Primary outcomeConservation 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 outcome1. 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)donor site complication (only Group autogenous bone graft).
- 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)
- Brief summary
- Main changes (audit trail)
- RECORD15-sep-2005 - 1-feb-2010


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