|- candidate number||10652|
|- NTR Number||NTR3185|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2011|
|- Secondary IDs||38864.091.11 CMO Regio Arnhem-Nijmegen|
|- Public Title||Open vs closed tibial osteotomy.|
|- Scientific Title||Midterm results open versus closed wedge high tibial osteotomy: A follow-up study.|
|- hypothesis||Primary 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) studied||Open wedge, Closed wedge, Tibial osteotomy, Midterm results|
|- Inclusion criteria||1. Patients who had a CWO or OWO and participated in the study CMO 2002/181;|
2. See protocol CMO 2002/81.
|- Exclusion criteria||See protocol CMO 2002/81.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2012|
|- planned closingdate||1-dec-2012|
|- Target number of participants||50|
|- Interventions||None, this is a follow-up study for midterm results of an earlier study of Gaasbeek et al (CMO 2002/81).|
|- Primary outcome||Survival rates with as endpoints TKA/UKA and re-operations at 5 year.|
|- Secondary outcome||Visual Analogue Scale pain, VAS satisfaction, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS) and complications.
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.
|- Timepoints||The patients will be invited to visit the clinic once spread over a couple of weeks (starting 1-3-2012).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| S. Grinsven, van|
|- CONTACT for SCIENTIFIC QUERIES|| C.J.M. Loon, van|
|- Sponsor/Initiator ||Rijnstate Ziekenhuis, Arnhem, Maatschap Orthopaedie|
(Source(s) of Monetary or Material Support)
|Ziekenhuis Rijnstate, Arnhem, Maatschap Orthopaedie|
|- Brief summary||Rationale: |
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.
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.
A multicentre prospective study.
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)|
|- RECORD||8-dec-2011 - 22-sep-2012|