Comparison of the accuracy of achieved correction of the mechanical axis in the frontal plane relative to preoperative planning, endeavouring to achieve an overcorrection of a varus malalignment to 3-4° of valgus, comparing open and closed HTO*s.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is difference between the pre-planned correction
and the achieved correction both the hip-knee ankle angle and lateralisation of
the mechanical axis. The goal of the osteotomy is to achieve a 3-4 degrees
overcorrection (valgus) in the frontal plane (Hip Knee Ankle angle). The final
achieved correction will be assessed at the whole leg radiograph 6 weeks
postoperatively.
Secondary outcome
Difference in the following outcome parameter after 6 weeks, 12 and 24 months
and 5 years, in pain severity (Visual Analogue Scale; VAS), Knee injury and
Osteoarthritis Outcome Score (KOOS), Hospital for Special Surgery scale (HSS).
Also difference in complications, side effects, and medicine consumption will
be assessed. A blinded physical examination (bandage over the whole proximal
tibia) of the knee will be performed (stability of the medial and lateral
collateral ligaments, and range of motion). A true lateral radiograph of the
knee in at least 30 degrees of flexion will be used to determine the length of
the patella tendon according to Insall-Salvati (IS ratio). The posterior
inclination angle of the tibia plateau (PI) will be measured on a lateral
radiograph according to Moore-Harvey. Bone mineral density of the medial and
lateral compartment of the tibia (predefined regions of interest) will be
assessed by DXA scan. A DXA scan will be performed preoperatively and
postoperatively at 6 weeks, 12 and 24 months. Whole leg radiographs will be
made preoperatively and direct postoperatively, followed by 6 weeks, 24 months,
and five years postoperatively.
Background summary
An open wedge high tibial osteotomy (HTO) is thought to allow more accurate
adjustment of the attained tibial correction before final fixation than a
closed wedge HTO. Locking plate fixation has led to improved stability when
used in open and closed HTO. Its use should lead to more accurate and enduring
correction in open wedge HTO*s as compared to closed wedge HTO*s.
Study objective
Comparison of the accuracy of achieved correction of the mechanical axis in the
frontal plane relative to preoperative planning, endeavouring to achieve an
overcorrection of a varus malalignment to 3-4° of valgus, comparing open and
closed HTO*s.
Study design
In the present single-blinded study (post-operative evaluators and data
analyst); patients will be randomized in group (a) a closed wedge high tibial
osteotomy will be performed; or in group (b) an open wedge high tibial
osteotomy will be performed.
Intervention
A Randomized Control Trial comparing open and closed wedge HTO*s, both using
locking plate fixation and with identical postoperative care.
Study burden and risks
The burden is primarily time (questionnaires and DXA scans). There is no direct
benefit from participation or group relatedness. Open and closed wedge HTO*s
are both options in the standard care of active patients, younger than 65, with
medial compartment osteoarthritis of the knee.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
knee pain located over the medial tibiofemoral compartment of the knee, knee pain for more than 3 months, with a severity of the knee pain of more than 20 mm on a VAS score (range 0 to 100 mm), radiographic signs of knee OA, defined by a Kellgren & Lawrence score of grade 1-3, and presence of varus malalignment as measured on a whole leg radiograph.
Exclusion criteria
OA of the lateral compartment, grade-3 collateral ligament laxity, range of motion of < 100°, a flexion contracture of > 10°, history of fracture or previous open operation of the lower limb, ACL rupture, rheumatoid arthritis, patients with a contralateral HTO will be excluded if the first knee has been included in this trial; thus, if both knees are symptomatic, only the first knee will be included, patients from whom it is not sure that they will be able to attend the follow-up measurements, insufficient command of the Dutch language, spoken and/or written.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL32423.078.10 |