No registrations found.
ID
Source
Brief title
Health condition
Medial compartment osteoarthritis of the knee
Sponsors and support
Intervention
Outcome measures
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);
2. Complications;
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.
Background 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.
Study objective
An open wedge high tibial osteotomy (HTO) is thought to allow more accurate adjustment of the attained tibial correction.
Study design
Preoperatively, 6 weeks, 12, 24 and 60 months postoperatively.
Intervention
Open and closed wedge HTO's, both using locking plate fixation and with identical postoperative care.
PO box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4033642
m.reijman@erasmusmc.nl
PO box 2040
M. Reijman
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4033642
m.reijman@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3358 |
| NTR-old | NTR3506 |
| CCMO | NL32423.078.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34209 |