|- candidate number||8445|
|- NTR Number||NTR2506|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-sep-2010|
|- Secondary IDs||2010-181 MEC Erasmus MC|
|- Public Title||Vergelijking van twee standscorrectie operaties van het onderbeen bij knieartrose.|
|- Scientific Title||Accuracy of achieved correction of open versus closed wedge high tibial osteotomies, with locking plate fixation.|
|- hypothesis||Comparison of the accuracy of achieved correction of the mechanical axis in the frontal plane relative to preoperative planning endeavouring to achieve 3-4° of valgus between open and closed HTO’s.|
|- Healt Condition(s) or Problem(s) studied||Varus knee, Isolated medial compartment osteoarthritis (OA)|
|- Inclusion criteria||1. Knee pain located over the medial tibiofemoral compartment of the knee;|
2. Knee pain for more than 3 months, with a severity of the knee pain of more than 20 mm on a VAS score (range 0 to 100 mm);
3. Radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1-3;
4. Presence of varus malalignment as measured on a whole leg radiograph.
|- Exclusion criteria||1. OA of the lateral compartment;|
2. Grade-3 collateral ligament laxity;
3. Range of motion of < 100°;
4. A flexion contracture of > 10°;
5. History of fracture or previous open operation of the lower limb;
6. ACL rupture;
7. Rheumatoid arthritis;
8. Patients with a contralateral HTO will be excluded if the first knee has been included in this trial; thus, if both knees are symptomatic, only the first knee will be included;
9. Patients from whom it is not sure that they will be able to attend the follow-up measurements;
10. 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-okt-2010|
|- planned closingdate||1-okt-2015|
|- Target number of participants||124|
|- Interventions||1. Group A: Medial open wedge high tibial osteotomy;|
2. Group B: Lateral closed wedge high tibial osteotomy.
Both techniques using locking plate fixation and with identical postoperative care.
|- Primary outcome||The main endpoint of the study is difference between the pre-planned correction and the achieved correction both the hip-knee ankle angle and lateralisation of the mechanical axis. The goal of the osteotomy is to achieve a 3-4 degrees overcorrection (valgus) in the frontal plane (Hip Knee Ankle angle). The final achieved correction will be assessed at the whole leg radiograph 6 weeks postoperatively. |
|- Secondary outcome||Difference in the following outcome parameter after 6 weeks, 12 and 24 months and 5 years, in pain severity (Visual Analogue Scale; VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), Hospital for Special Surgery scale (HSS). Also difference in complications, side effects, and medicine consumption will be assessed. A blinded physical examination (bandage over the whole proximal tibia) of the knee will be performed (stability of the medial and lateral collateral ligaments, and range of motion). A true lateral radiograph of the knee in at least 30 degrees of flexion will be used to determine the length of the patella tendon according to Insall-Salvati (IS ratio). The posterior inclination angle of the tibia plateau (PI) will be measured on a lateral radiograph according to Moore-Harvey. Bone mineral density of the medial and lateral compartment of the tibia (predefined regions of interest) will be assessed by DXA scan. A DXA scan will be performed preoperatively and postoperatively at 6 weeks, 12 and 24 months. Whole leg radiographs will be made preoperatively and direct postoperatively, followed by 6 weeks, and 24 months postoperatively.|
|- Timepoints||Patient recruitment should take 3 years. Follow-up measurements at 6 weeks, 12 and 24 months will be performed.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||PhD, senior researcher M. Reijman|
|- CONTACT for SCIENTIFIC QUERIES||PhD, senior researcher M. Reijman|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Rationale:|
An open wedge high tibial osteotomy (HTO) is thought to allow more accurate adjustment of the attained tibial correction before final fixation than a closed wedge HTO. Locking plate fixation has led to improved stability when used in open and closed HTO. Its use should lead to more accurate and enduring correction in open wedge HTO’s as compared to closed wedge HTO’s.
Comparison of the accuracy of achieved correction of the mechanical axis in the frontal plane relative to preoperative planning, endeavouring to achieve an overcorrection of a varus malalignment to 3-4° of valgus, comparing open and closed HTO’s.
Patients, age 18–60, with isolated medial compartment osteoarthritis (OA), concomitant with a varus mechanical axis of the knee, good range of motion and limited ligamentous knee laxity.
A Randomized Control Trial comparing open and closed wedge HTO’s, both using locking plate fixation and with identical postoperative care.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden is primarily time (questionnaires and DXA scans). There is no direct benefit from participation or group relatedness. Open and closed wedge HTO’s are both options in the standard care of active patients, younger than 65, with medial compartment osteoarthritis of the knee.
|- Main changes (audit trail)|
|- RECORD||14-sep-2010 - 21-sep-2010|