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

Phase 4

Completed

• Conditions: Coxarthrosis
• Interventions: Procedure: primary total hip arthroplasty

• Registration Number: NCT01435850
• Lead Sponsor: Smith & Nephew Orthopaedics AG

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 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-19
• Primary Completion: 2012-10
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIP STEM SL PLUS	primary total hip arthroplasty	study group
HIP STEM SL PLUS MIA	primary total hip arthroplasty	control group

Primary Outcome Measures

Name	Time	Method
Stability of primary total hip arthroplasty	24 months	Study compares the stability of two types of hip stems using the Femoral Component Analysis (FCA-EBRA)method. 4 images of a-p pelvic view will be collected over a 2-year period: at 6 weeks, 6, 12 and 24 months.

Secondary Outcome Measures

Name	Time	Method
Harris Hip Score	24 months	Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.
Oxford Hip Score	24 months	According to Delaunay C, Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population, Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. Epub 2009 Apr 3.; Oxford Hip Score will be measured pre-operatively, after 6 weeks, 6, 12 and 24 months.

Trial Locations

Locations (1)

Hopital Salengro, Service d'Orthopédie C; 🇫🇷 Lille Cedex, France