No registrations found.
ID
Source
Brief title
Health condition
This case control study will review a cohort (n= 899 cases) of patients operated for unilateral total knee arthroplasty (TKA) with the use of patient specific matched instruments (PSMI; Signature, Biomet, Warsaw INC).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes to the plan, the surgeon can modify the settings for femur and tibia alignment.
Secondary outcome
The surgeon is also able to change the size for femur or tibia implant.
Background summary
To our knowledge, no studies have yet been conducted comparing the pre-operative planning of patients between orthopedic surgeons, experienced with patient specific matched instruments.
This study is designed to address the following research question: is there a significant difference between the alignment of the individual femoral and tibial components as planned.
Study objective
We hypothesise that there would be no significant difference between the preoperative planning between different orthopedic surgeons.
Study design
N/A
Intervention
Fifty cases will be random selected from the total cohort. The planning of these cases will be evaluated by 10 international orthopedic surgeons experienced with patient matched instruments. No patients are involved, only the pre operative plan of patients will be used.
Based on 50 plans for each surgeon, inter observer variability will be calculated
Twenty five cases will be random selected from the total cohort. The planning of these cases will be evaluated by 4 orthopedic surgeons. Each case will be planned for 3 times by each surgeon. Surgeons in Orbis Medisch Centrum will participate in this study. No patients are involved, only the pre operative plan of operated patients will be used.
Based on 3 plans for each case, intra-observer variability will be calculated
Based on 25 plans for each surgeon, inter observer variability will be calculated
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
Pre operative planned TKA of patients with PSMI
Exclusion criteria
N/A
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 | NL3968 |
| NTR-old | NTR4127 |
| Other | METC Atrium-Orbis-Zuyd : 13N107 and 13N108 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |