Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem (SL-PLUS)
Primary Purpose
Coxarthrosis
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
primary total hip arthroplasty
Sponsored by
About this trial
This is an interventional health services research trial for Coxarthrosis focused on measuring hip arthroplasty, primary stability, secondary stability, EBRA
Eligibility 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
Sites / Locations
- Hopital Salengro, Service d'Orthopédie C
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
HIP STEM SL PLUS
HIP STEM SL PLUS MIA
Arm Description
study group
control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Harris Hip Score
Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.
Full Information
NCT ID
NCT01435850
First Posted
September 13, 2011
Last Updated
April 1, 2015
Sponsor
Smith & Nephew Orthopaedics AG
1. Study Identification
Unique Protocol Identification Number
NCT01435850
Brief Title
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
Acronym
SL-PLUS
Official Title
"Enfoncement de la Tige SL-PLUS et de la Tige SL-PLUS MIA:Etude Comparative"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew Orthopaedics AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
hip arthroplasty, primary stability, secondary stability, EBRA
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HIP STEM SL PLUS
Arm Type
Sham Comparator
Arm Description
study group
Arm Title
HIP STEM SL PLUS MIA
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Procedure
Intervention Name(s)
primary total hip arthroplasty
Other Intervention Name(s)
SL-PLUS, SL-PLUS MIA, Lateralized hip stem
Intervention Description
All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
Primary Outcome Measure Information:
Title
Stability of primary total hip arthroplasty
Description
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
Secondary Outcome Measure Information:
Title
Oxford Hip Score
Description
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
Title
Harris Hip Score
Description
Harris Hip Score will be measured pre-operatively, after 6, 12 and 24 months. No measurement after 6 weeks.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Migaud, MD, Pr.
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Salengro, Service d'Orthopédie C
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
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