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

Smith & Nephew Orthopaedics AG80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Coxarthrosis

Interventions

primary total hip arthroplastyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Salengro, Service d'Orthopédie C

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Harris Hip Score

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

Time frame: 24 months

Data from ClinicalTrials.gov

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