Our primary objective is to compare the midterm clinical and radiographic results (6 to 8 years) of CWO versus OWO with a locked plate fixation in the management of patients with medial knee OA and a varus leg alignment with a prospective follow-up…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to compare the midterm clinical and radiographic
results (6 to 8 years) of CWO versus OWO with a locked plate fixation in the
management of patients with medial knee OA and a varus leg alignment with a
prospective follow-up study (of a previous RCT conducted by Gaasbeek et al.:
CMO number 2002/181).The primary result is the survival rate at 5 year with as
endpoints conversion to TKA or UKA and re-operation.
Secondary outcome
Visual Analogue Scale pain, VAS satisfaction, the Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC), Knee Society Score (KSS) and
complications
Radiographic evaluation:
Radiographs of varus leg alignment (loss of correction), of OA of the knee on
AP and lateral views radiographs, Caton*s index (CI) and tibial slope on true
lateral radiograph views in 30gr of flexion.
Background summary
Knee osteoarthritis (OA) is one of the most common joint disorders and is a
major cause of knee pain and immobility. Treatment can be non-operative or
operative. In young patients it is desirable to delay primary arthroplasty.
Osteoarthritis of the knee is more frequently located in the medial
compartment. Patients with OA of the medial compartment often have varus
malalignment and this causes an overload of the medial compartment. In order to
unload the medial compartment, valgus high tibial osteotomy is the treatment of
choice for the young and active patient. Either a closed wedge osteotomy (CWO),
or an open wedge osteotomy (OWO) can be performed.
Closed wedge osteotomy is the conventional approach that was used for varus
gonarthrosis. OWO has become popular more recently. Each option has individual
advantages and complications. Between 2003 and 2005, we performed a randomized
clinical trial in which we compared CWO and OWO (CMO-nr 2002/181) in 50
patients. A follow-up study is needed to evaluate the midterm results of this
cohort.
Study objective
Our primary objective is to compare the midterm clinical and radiographic
results (6 to 8 years) of CWO versus OWO with a locked plate fixation in the
management of patients with medial knee OA and a varus leg alignment with a
prospective follow-up study (of a previous RCT conducted by Gaasbeek et al.:
CMO number 2002/181).
Study design
A multicentre prospective study.
Study burden and risks
The extra burden associated with participation in this study are radiographs of
the knee and standing whole leg alignment X-rays. Patients are invited to visit
the clinic once for the radiographs. The Visual Analogue Scale pain and
satisfaction, the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC) and the Knee Society Score (KSS) are scored.
Wagnerlaan 55
6800 TA Arnhem
NL
Wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
Patients who had a CWO or OWO and participated in the study CMO 2002/181
Exclusion criteria
-
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 | Het wordt aangemeld in het Nederlands Trial register (registratienummer is nog niet bekend). |
| CCMO | NL38864.091.11 |