No registrations found.
ID
Source
Health condition
consecutive patients with debilitating osteoarthritis of the knee joint
patient specific, TKA, industrie, alignment, cutting guide, pin guide,
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pre operative approved planning for the femur and tibia component were compared with the post operative achieved alignment of each component on radiographs.
Biomechanical limb alignment and implant position were measured with a calibrated protocol on digital images on a PACS system [Boonen et al 2012,Boonen et al 2013]. Biomechanical axis (HKA: Hip-Knee-Ankle angle) was evaluated on standardized 1-year postoperative coronal full leg standing radiographs. Varus/ valgus position of the femur (FFC) and tibia (FTC) components perpendicular to the HKA angle were measured on the same coronal radiographs.
Secondary outcome
Flexion/ extension of the femur component (LFC), measured from the anterior femoral cortex and posterior or anterior slope of the tibia component (LTC) measured from the posterior cortex of the tibia, were evaluated on 1-year postoperative lateral radiographs. Deviations >3 degrees between pre-operative planned HKA (sum of FFC and FTC) and individual components (FFC, FTC, LFC and LTC) compared to post operative achieved alignment on radiographs, were considered as outliers.
Study objective
There is no difference between the different PSG systems if it becomes to outliers of the biomechanical axis
Study design
Pre-, 6 weeks and 12 monts post-operative
Intervention
PSG from the following manufaturer
TruMatch system
Visionaire system
Patient Specific Instrument system
Signature system
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Inclusion criteria
- eligible for primary unilateral TKA
- able and willing to participate
- written consent
Exclusion criteria
Patients who were not eligible to undergo MRI due to metal artefacts around the knee joint from previous surgery, claustrophobia, movement artefacts during MRI scanning time, pigmented villonodular synovitis (PVNS), implanted electronic devices (e.g. pacemaker, neurostimulator for bladder control or cochlear implants).
Patients that refused to consent were excluded.
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 | NL4571 |
| NTR-old | NTR4739 |
| Other | 13.007 : 13N09 |