Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem (SL-PLUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier:
NCT01435850
First received: September 13, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Coxarthrosis
Procedure: primary total hip arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: "Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"

Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Stability of primary total hip arthroplasty [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Oxford Hip Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.


Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: HIP STEM SL PLUS
study group
Procedure: primary total hip arthroplasty
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
Other Name: SL-PLUS, SL-PLUS MIA, Lateralized hip stem
Active Comparator: HIP STEM SL PLUS MIA
control group
Procedure: primary total hip arthroplasty
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
Other Name: SL-PLUS, SL-PLUS MIA, Lateralized hip stem

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435850

Locations
France
Hopital Salengro, Service d'Orthopédie C
Lille Cedex, France, 59037
Sponsors and Collaborators
Smith & Nephew Orthopaedics AG
Investigators
Principal Investigator: Henri Migaud, MD, Pr. University Hospital
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc. ( Smith & Nephew Orthopaedics AG )
ClinicalTrials.gov Identifier: NCT01435850     History of Changes
Other Study ID Numbers: D10056-2-F
Study First Received: September 13, 2011
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Smith & Nephew, Inc.:
hip arthroplasty
primary stability
secondary stability
EBRA

Additional relevant MeSH terms:
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Osteoarthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014