Coxarthrosis Clinical Trial
Official title:
"Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL
PLUS (study group).
We compare primary and secondary stability of both hip stems for radiographic outcome using
EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip
score and radiographic findings.
This study is a monocentric study, randomized and controlled including two types of hip
stems: SL PLUS MIA (control group) and SL PLUS (study group).
Each group will include 45 patients where a number of 5 patients for each group calculated
extra in case of loss.
Patients will be followed after
- 6 weeks
- 6 months
- 12 months
- 24 months. Radiographs are taken in a-p and lateral view using a standard protocol.
Primary and secondary stability of both hip stems will be analyzed using the EBRA
software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the
completion of the two year follow-up.
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip
score and radiographic findings such as radiolucent lines.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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