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

Coxarthrosis Clinical Trial

— SL-PLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435850
• Other study ID #: D10056-2-F
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: April 1, 2015
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Procedure:
• primary total hip arthroplasty
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.

Locations

Country	Name	City	State
France	Hopital Salengro, Service d'Orthopédie C	Lille Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stability of primary total hip arthroplasty	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.	24 months	No
Secondary	Oxford Hip Score	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.	24 months	No
Secondary	Harris Hip Score	Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.	24 months	No