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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coxarthrosis

Intervention / Treatment
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* Procedure: primary total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: HIP STEM SL PLUS<br>study group | Procedure: primary total hip arthroplasty<br>* All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.<br>* Other names: SL-PLUS, SL-PLUS MIA, Lateralized hip stem;|
| Active Comparator: HIP STEM SL PLUS MIA<br>control group | Procedure: primary total hip arthroplasty<br>* All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.<br>* Other names: SL-PLUS, SL-PLUS MIA, Lateralized hip stem;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip arthroplasty, primary stability, secondary stability, EBRA