No registrations found.
ID
Source
Brief title
Health condition
Medial compartment osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is achievement of an overcorrection of 4 degrees valgus after one year of surgery (HKA angle).
Secondary outcome
Secondary Objectives are to compare these two different HTO techniques regarding radiological scores/ anatomical changes after HTO (Moore-Harvey, Dejour-Bonin, Insall-Salvati and Caton Index). Moreover pain, function scores and quality of life will be compared (VAS and KOOS).
Background summary
High tibial osteotomy (HTO) is a common procedure to treat symptomatic osteoarthritis of the medial compartment of the knee with varus alignment. This is achieved by overcorrecting the varus alignment to 2-6 degrees of valgus. To achieve this, different HTO techniques are being used. The most common used techniques are medial opening wedge (MOW) and lateral closing wedge (LCW) HTOs. A Cochrane review showed no
evidence whether LCW or MOW is more effective in the treatment of symptomatic medial knee OA, however the LCW is seen as the gold standard. A relatively new technique, the combined valgus producing high tibial osteotomy (CWO), claims to include the advantages of both techniques. This HTO modification avoids metaphyseal tibial bone loss, and decreases the transposition of the tibia condyle and shortening of the patellar tendon after osteotomy even in case of great correction. During the last few years, both the LCW and CWO techniques are commonly used for HTO at the department of Orthopaedics of the Martini Hospital. The clinical results of the CWO technique are very promising. However, until now, there is little scientific evidence on the effectiveness of CWO. Objective of the study: Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
Study objective
Aim of this prospective randomized trial (RCT) is to compare the gold standard LCW with the CWO in patients eligible for HTO who need a correction of 10 to 16 degrees. Hypothesis is that the CWO technique will achieve more accurate overcorrection of varus malalignment with less anatomical changes of the proximal tibia after 1 year.
Study design
Preoperatively and 6 weeks, 6 months and one year postoperatively.
Intervention
Patients will undergo a HTO, with either a LCW technique or a CWO technique.
Van Swietenplein 1
M.R. Huizinga
Groningen 9728 NT
The Netherlands
+31 (0)50 5245970
m.r.huizinga@mzh.nl
Van Swietenplein 1
M.R. Huizinga
Groningen 9728 NT
The Netherlands
+31 (0)50 5245970
m.r.huizinga@mzh.nl
Inclusion criteria
1. Radiologically confirmed medial compartment osteoarthritis of the knee;
2. Medial joint pain;
3. Varus alignment between 6-12 degrees;
4. An age of 18 and older.
Exclusion criteria
1. Symptomatic osteoarthritis of the lateral compartment;
2. Rheumatoid arthritis;
3. Range of motion of the knee joint less than 100 degrees;
4. Flexion contracture more than 10 degrees.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3735 |
| NTR-old | NTR3898 |
| Other | METC : 43154.099.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |