Hopital Salengro, Service d'Orthopédie C
Lille, 59037, France
NCT Number: NCT01435850
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Lille, 59037, France
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
Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.
Smith & Nephew Orthopaedics AG
Industry
"Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
Acronym: SL-PLUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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