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Open vs closed tibial osteotomy.


- candidate number10652
- NTR NumberNTR3185
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2011
- Secondary IDs38864.091.11 CMO Regio Arnhem-Nijmegen
- Public TitleOpen vs closed tibial osteotomy.
- Scientific TitleMidterm results open versus closed wedge high tibial osteotomy: A follow-up study.
- ACRONYM
- hypothesisPrimary Objective:
Our primary objective is to compare the midterm clinical and radiographic results (6 to 8 years) of CWO versus OWO with a locked plate fixation in the management of patients with medial knee OA and a varus leg alignment with a prospective follow-up study (of a previous RCT conducted by Gaasbeek et al.: CMO number 2002/181). The primary result is the survival rate at 5 year with as endpoints conversion to TKA or UKA and re-operation.
- Healt Condition(s) or Problem(s) studiedOpen wedge, Closed wedge, Tibial osteotomy, Midterm results
- Inclusion criteria1. Patients who had a CWO or OWO and participated in the study CMO 2002/181;
2. See protocol CMO 2002/81.
- Exclusion criteriaSee protocol CMO 2002/81.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-mrt-2012
- planned closingdate1-dec-2012
- Target number of participants50
- InterventionsNone, this is a follow-up study for midterm results of an earlier study of Gaasbeek et al (CMO 2002/81).
- Primary outcomeSurvival rates with as endpoints TKA/UKA and re-operations at 5 year.
- Secondary outcomeVisual Analogue Scale pain, VAS satisfaction, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS) and complications.

Radiographic evaluation:
Radiographs of varus leg alignment (loss of correction), of OA of the knee on AP and lateral views radiographs, Caton’s index (CI) and tibial slope on true lateral radiograph views in 30gr of flexion.
- TimepointsThe patients will be invited to visit the clinic once spread over a couple of weeks (starting 1-3-2012).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Grinsven, van
- CONTACT for SCIENTIFIC QUERIES C.J.M. Loon, van
- Sponsor/Initiator Rijnstate Ziekenhuis, Arnhem, Maatschap Orthopaedie
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuis Rijnstate, Arnhem, Maatschap Orthopaedie
- PublicationsN/A
- Brief summaryRationale:
Knee osteoarthritis (OA) is one of the most common joint disorders and is a major cause of knee pain and immobility (1,2). Treatment can be non-operative or operative. In young patients it is desirable to delay primary arthroplasty. Osteoarthritis of the knee is more frequently located in the medial compartment. Patients with OA of the medial compartment often have varus malalignment and this causes an overload of the medial compartment with increasing symptoms during weight bearing. Malalignment increases risk for progression of knee OA (1,3-8). In order to unload the medial compartment, valgus high tibial osteotomy is the treatment of choice for the young and active patient. Either a closed wedge osteotomy (CWO), or an open wedge osteotomy (OWO) can be performed.
Closed wedge osteotomy is the conventional approach that was used for varus gonarthrosis (7,9-14). OWO has become popular more recently (1,6,15-24). Other various techniques are also described, such as a dome osteotomy and the hemicallotasis technique (1,3,4,6,7,25-28). The CWO and OWO are the most common used techniques. Each option has individual advantages and complications (1,3-7,14,19,30-36). Between 2003 and 2005, we performed a randomized clinical trial in which we compared CWO and OWO (CMO-nr 2002/181) in 50 patients(30). A follow-up study is needed to evaluate the midterm results of this cohort.

Objective:
Our primary objective is to investigate the midterm results (6 to 8 years) of CWO versus OWO in a prospective study, a follow-up study of CMO 2002/181.

Study design:
A multicentre prospective study.

Study population:
Patients who had CWO or OWO surgery between January 2003 and march 2005 in Rijnstate Hospital Arnhem or University Medical Centre St Radboud in Nijmegen, the Netherlands and participated in the study “Correction accuracy and collateral laxity in open versus closed wedge high tibial osteotomy”. Intervention (if applicable): None. Main study parameters/endpoints: Survival rates at five year using the Kaplan-Meier method with the end points revision to TKA or UKA, and re-operation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The extra burden associated with participation in this study are radiographs of the knee and standing whole leg alignment X-rays. Patients are invited to visit the clinic once for the radiographs. The Visual Analogue Scale pain and satisfaction, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Score (KSS) are scored.
- Main changes (audit trail)
- RECORD8-dec-2011 - 22-sep-2012


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