Coxarthrosis
Conditions
Keywords
hip arthroplasty, primary stability, secondary stability, EBRA
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.
Interventions
PROCEDUREprimary total hip arthroplasty
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Harris Hip Score | 24 months | Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks. |
Countries
France
Outcome results
None listed