Status:
COMPLETED
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Coxarthrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
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 numbe...
Eligibility Criteria
Inclusion
- Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
- Age at surgery : 18-80 years old
- Patient has social security number
- Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control
Exclusion
- Patient's BMI is over 35
- Patient has bone tumors that can affect implant stability
- Patient needs cortical steroid treatment
- Patient needs hip revision arthroplasty
- Patient has general inflammation that could affect bone quality
- Patients classified Charnley C
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01435850
Start Date
April 1 2009
End Date
November 1 2014
Last Update
April 3 2015
Active Locations (1)
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1
Hopital Salengro, Service d'Orthopédie C
Lille, France, 59037