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Standscorrectie van het onderbeen door een enkelvoudige laterale gesloten wig (LGW) of een gecombineerde dubbele wig CW), bij slijtage aan de binnenzijde van het kniegewricht.


- candidate number14508
- NTR NumberNTR3898
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-mrt-2013
- Secondary IDs43154.099.13 METC
- Public TitleStandscorrectie van het onderbeen door een enkelvoudige laterale gesloten wig (LGW) of een gecombineerde dubbele wig CW), bij slijtage aan de binnenzijde van het kniegewricht.
- Scientific TitleCombined wedge osteotomy (CWO) versus lateral closed wedge osteotomie (LCW) in medial compartment osteoarthritis of the knee.
- ACRONYMCombined wedge osteotomy versus closed wedge osteotomy
- hypothesisAim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
- Healt Condition(s) or Problem(s) studiedMedial compartment osteoarthritis
- Inclusion criteria1. Radiologically confirmed medial compartment osteoarthritis of the knee;
2. Medial joint pain;
3. Varus alignment between 6-12 degrees;
4. An age of 18 and older.
- Exclusion criteria1. Symptomatic osteoarthritis of the lateral compartment;
2. Rheumatoid arthritis;
3. Range of motion of the knee joint less than 100 degrees;
4. Flexion contracture more than 10 degrees.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2013
- planned closingdate1-apr-2015
- Target number of participants110
- InterventionsPatients will undergo a HTO, with either a LCW technique or a CWO technique.
- Primary outcomePrimary outcome measure is achievement of an overcorrection of 4 degrees valgus after one year of surgery (HKA angle).
- Secondary outcomeSecondary Objectives are to compare these two different HTO techniques regarding radiological scores/ anatomical changes after HTO (Moore-Harvey, Dejour-Bonin, Insall-Salvati and Caton Index). Moreover pain, function scores and quality of life will be compared (VAS and KOOS).
- TimepointsPreoperatively and 6 weeks, 6 months and one year postoperatively.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.R. Huizinga
- CONTACT for SCIENTIFIC QUERIES M.R. Huizinga
- Sponsor/Initiator Martini Hospital, Department of Orthopaedic Surgery,
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital, Department of Orthopaedic Surgery
- PublicationsN/A
- Brief summaryHigh tibial osteotomy (HTO) is a common procedure to treat symptomatic osteoarthritis of the medial compartment of the knee with varus alignment. This is achieved by overcorrecting the varus alignment to 2-6 degrees of valgus. To achieve this, different HTO techniques are being used. The most common used techniques are medial opening wedge (MOW) and lateral closing wedge (LCW) HTOs. A Cochrane review showed no evidence whether LCW or MOW is more effective in the treatment of symptomatic medial knee OA, however the LCW is seen as the gold standard. A relatively new technique, the combined valgus producing high tibial osteotomy (CWO), claims to include the advantages of both techniques. This HTO modification avoids metaphyseal tibial bone loss, and decreases the transposition of the tibia condyle and shortening of the patellar tendon after osteotomy even in case of great correction. During the last few years, both the LCW and CWO techniques are commonly used for HTO at the department of Orthopaedics of the Martini Hospital. The clinical results of the CWO technique are very promising. However, until now, there is little scientific evidence on the effectiveness of CWO. Objective of the study: Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
- Main changes (audit trail)
- RECORD12-mrt-2013 - 11-apr-2013


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