1. To assess the effects of a CWHTO on the MCL and LCL laxity.2. To assess the effects of a CWHTO on the patient*s experience of collateral ligament instability.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in radiologically measured joint
opening (in degrees) on the medial and lateral side of the knee when testing
the MCL and LCL tension laxity in extension and flexion before and after a
CWHTO.
Secondary outcome
The secondary study parameter is the difference in patient*s subjectively
experienced varus/valgus instability before and after a CWHTO.
Background summary
The use of osteotomies to correct angular deformities around the knee has been
a surgical option for delaying, and potentially preventing, the progression of
knee osteoarthritis, especially in younger and physically more active patients
in whom total knee arthroplasty is undesirable. A varus producing medial
closing wedge high tibial osteotomy (CWHTO) can be used to treat valgus
malalignment deformity of the knee. Coventry (1985, 1987) stated that, by
removing a bony wedge on the medial side of the proximal tibia, a laxity of the
superficial medial collateral ligament (MCL) is introduced. Till date no study
has evaluated the MCL-laxity before and after a varus producing medial CWHTO
for valgus malalignment of the knee. We hypothesize that MCL laxity does not
change after a CWHTO, and that the lateral collateral ligament (LCL) laxity
also does not change after a CWHTO. Furthermore, we hypothesize that
varus/valgus instability is not subjectively experienced after a CWHTO.
Study objective
1. To assess the effects of a CWHTO on the MCL and LCL laxity.
2. To assess the effects of a CWHTO on the patient*s experience of collateral
ligament instability.
Study design
Investigator-initiated prospective observational pilot cohort study
The study will be performed at the Maartenskliniek Woerden.
Measurement points are: preoperative and six months postoperative.
Study burden and risks
The burden to the adult patient is two sets of short questionnaires (one
preoperative and one postoperative at six months) and eight additional stress
radiographs of the knee (four preoperative and four at six months
postoperative). Study visits can be combined with the day of the surgery and
the already planned visits to the outpatient clinic. The patient will receive
refund of travel expenses in case it is not possible to combine the
postoperative measurement with a visit of the outpatient clinic. There are no
known risks of the ligamentous stress apparatus, which is routinely used in
orthopaedic outpatient clinic care.
Polanerbaan 2
Woerden 3447 GN
NL
Polanerbaan 2
Woerden 3447 GN
NL
Listed location countries
Age
Inclusion criteria
1. Symptomatic valgus malalignment located in the proximal (high) tibia
2. Indication of a CWHTO, based on the severity of the complaints and the observed deformity according to Paley (2002)
3. Age 18-65 yr
4. No knee ligament laesions
Exclusion criteria
1. previous MCL surgery
2. previous ipsilateral total hip replacement
3. BMI greater than 30
4. Valgus malalignment for which the orthopaedic surgeon does not see an indication for CWHTO
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 |
|---|---|
| CCMO | NL52106.048.15 |