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Should a patient with medial knee osteoarthritis be operated?


- candidate number16182
- NTR NumberNTR4411
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2014
- Secondary IDsNL45685.078.13 
- Public TitleShould a patient with medial knee osteoarthritis be operated?
- Scientific TitleShould a patient with medial knee osteoarthritis be operated?
- ACRONYMBVO Trial
- hypothesisA high tibial osteotomy is an effective intervention to treat patients with clinical complaints of medial knee osteoartritis (superiority study) compared to an orthopaedic unloader knee brace.
- Healt Condition(s) or Problem(s) studiedKnee osteoarhritis, Tibial osteotomy, Varus knee, MRI
- Inclusion criteria- age 18 - 65 - medial knee pain > 3 months - NRS score > 3 - radiographic signs of medial knee osteoartritis - varus malalignment > 0 en ≤14
- Exclusion criteria- Lateral compartment with Kellgren & Lawrence ≥ grade 2 - contraindication to one of the two interventions - rheumatoid arthritis - grade-3 collateral ligament laxity - a flexion contracture of > 10 - range of motion of < 100 - fracture or previous open operation of the lower limb - patients with a contralateral high tibial osteotomy will be excluded if the first knee has been included in this trial - patients that already used an orthopaedic knee brace for knee OA in the same knee - patients from whom it is not sure that they will be able to attend the follow-up measurements - insufficient command of the Dutch language, spoken and/or written
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate
- Target number of participants124
- Interventions- 62 patients will receive a high tibial osteotomy - 62 patients will receive an unloader brace
- Primary outcomeknee pain after one year of follow-up
- Secondary outcome1. Patient Reported Outcomes: pain severity, function, quality of life, physical activity and patient satisfaction; 2. Change in structural features with respect to cartilage and subchondral bone; 3. Adverse events; 4. Pain medication use; 5. Direct and indirect costs.
- TimepointsBaseline, 3, 6, 9, 12 and 24 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD. S. Bierma-Zeinstra
- CONTACT for SCIENTIFIC QUERIESPhD. S. Bierma-Zeinstra
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-jan-2014 - 5-apr-2014


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