Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem (SL-PLUS)

"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.

Study Overview

• Status: Completed
• Conditions: Coxarthrosis
• Intervention / Treatment: Procedure: primary total hip arthroplasty

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Lille Cedex, France, 59037
    • Hopital Salengro, Service d'Orthopédie C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: HIP STEM SL PLUS; study group	Procedure: primary total hip arthroplasty; All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.; Other Names: SL-PLUS, SL-PLUS MIA, Lateralized hip stem
ACTIVE_COMPARATOR: HIP STEM SL PLUS MIA; control group	Procedure: primary total hip arthroplasty; All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.; Other Names: SL-PLUS, SL-PLUS MIA, Lateralized hip stem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Harris Hip Score	Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.	24 months

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Henri Migaud, MD, Pr., University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: September 13, 2011
• First Submitted That Met QC Criteria: September 15, 2011
• First Posted (ESTIMATE): September 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: hip arthroplasty; primary stability; secondary stability; EBRA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: D10056-2-F