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Completed

NCT Number: NCT01435850

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Salengro, Service d'Orthopédie C

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

primary total hip arthroplasty

Procedure

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

Primary outcomes

  1. Stability of primary total hip arthroplasty

    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.

Secondary outcomes

  1. Oxford Hip Score

    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.

  2. Harris Hip Score

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

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

Acronym: SL-PLUS

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Sep 19, 2011
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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