NCT01435850

Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem

"Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Smith & Nephew Orthopaedics AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coxarthrosis

Interventions

Type	Name	Description
PROCEDURE	primary total hip arthroplasty	All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-10-01
• Completion: 2014-11-01
• First posted: 2011-09-19
• Last updated: 2015-04-03

Locations

1 site across 1 country: France