|- candidate number||13099|
|- NTR Number||NTR3506|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jul-2012|
|- Secondary IDs||NL32423.078.10 CCMO|
|- Public Title||Accuracy of achieved correction of open versus closed wedge high tibial osteotomies, with locking plate fixation.|
|- Scientific Title||Accuracy of achieved correction of open versus closed wedge high tibial osteotomies, with locking plate fixation.|
|- hypothesis||An open wedge high tibial osteotomy (HTO) is thought to allow more accurate adjustment of the attained tibial correction.|
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Knee|
|- Inclusion criteria||1. Age between 18-65 years;|
2. Knee pain located over the medial tibiofemoral compartment;
3. Kneepain ≥ 3 months;
4. VAS > 20 mm;
5. K&L grade I-III;
6. Varus malalignment measured on a whole leg radiograph (<12 degrees).
|- Exclusion criteria||1. OA of the lateral compartment;|
2. Grade III collateral ligament laxity;
3. ROM < 100 degrees;
4. Flexion contracture > 10 degrees;
5. History of fracture or previous open operation of the lower limb;
6. Reumatoid arthritis;
7. Contralateral HTO;
8. Insufficient command of the Dutch language, spoken and/ or written.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2018|
|- Target number of participants||124|
|- Interventions||Open and closed wedge HTO's, both using locking plate fixation and with identical postoperative care.|
|- Primary outcome||Comparison of the accuracy of achieved correction of the mechanical axis in the frontal plane relative to preoperative planning endeavouring to achieve 3-4 degrees of valgus between open and closed HTO's measured on a whole leg radiograph.
Timepoint: 6 weeks postoperatively
|- Secondary outcome||1. Functional outcomes: change in pain severity (Visual Analogue Scale; VAS), Knee
injury and Osteoarthritis Outcome Score (KOOS), Hospital for Special Surgery scale (HSS);|
3. Medial and lateral collateral ligamentous stability;
4. Change in Bone Mineral Density, measured by DXA scan, of medial and lateral
compartments, with the Regions Of Interest (ROI's) being in the tibia plateau;
5. Loss of correction;
6. Change of tibial slope;
7. Change of patellar height;
8. Plate irritation;
9. Patient satisfaction.
|- Timepoints||Preoperatively, 6 weeks, 12, 24 and 60 months postoperatively.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD, senior researcher M. Reijman|
|- CONTACT for SCIENTIFIC QUERIES||PhD, senior researcher M. Reijman|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Department of Orthopaedics|
|- Brief summary||A valgus high tibial osteotomy is one of the treatment modalities for people with severe unicompartimental osteoarthritis of the knee with varus malalignment. Besides the open wedge, is the closed wedge HTO a frequently used technique. A previous RCT showed that closed wedge osteotomy gave a more accurate correction. There was a loss correction in some cases in the open wedge HTO-group caused by instability of the lockingplate. Locking plate fixation has led to improved stability when used in open and closed HTO.|
An open wedge high tibial osteotomy (HTO) is thought to allow more accurate adjustment of the attained tibial correction.
The findings of this study will show us which technique is superior for correction of the mechanical axis.
We expect that an accurate correction of the mechanical axis of the knee, without loss of correction, will have a positive effect on the clinical results of this procedure.
|- Main changes (audit trail)|
|- RECORD||5-jul-2012 - 15-okt-2012|