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…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
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.
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
Randomized Controlled Trial.
Intervention
Patients will undergo a HTO, with either a LCW technique or a CWO technique.
Study burden and risks
There are no extra operative risk factors compared to usual treatment. Possible
benefits for the group of patients undergoing CWO could be less/no need for
reoperation concerning implant removal, less risk for change of posterior
tibial slope.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
- radiologically confirmed medial compartment osteoarthritis of the knee
- medial joint pain;
- varus alignment between 6-12 degrees;
- an age of 18 and older.
Exclusion criteria
- symptomatic osteoarthritis of the lateral compartment;
- rheumatoid arthritis;
- range of motion of the knee joint less than 100 degrees;
- flexion contracture more than 10 degrees;
- grade 3 collateral laxity (Insall);
- history of fracture or previous open operation of the lower extremity;
- mental incapacity;
- inability to fill in the questionnaires in Dutch.
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 |
|---|---|
| Other | Nederlands trial register, nummer volgt |
| CCMO | NL43154.099.13 |