We hypothesise that there would be no significant difference between the preoperative planning between different orthopedic surgeons.
ID
Bron
Verkorte titel
Aandoening
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).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changes to the plan, the surgeon can modify the settings for femur and tibia alignment.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesise that there would be no significant difference between the preoperative planning between different orthopedic surgeons.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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
Publiek
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Wetenschappelijk
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@orbisconcern.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Pre operative planned TKA of patients with PSMI
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
N/A
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL3968 |
NTR-old | NTR4127 |
Ander register | METC Atrium-Orbis-Zuyd : 13N107 and 13N108 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |