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 Orthopaedics AG

ClinicalTrials.gov Identifier:

NCT01435850

First received: September 13, 2011

Last updated: October 19, 2012

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2011

Last Updated Date

October 19, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01435850 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research

Condition ^ICMJE

Joint Replacement
Hip

Intervention ^ICMJE

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

Study Arm (s)

Sham Comparator: HIP STEM SL PLUS
study group

Intervention: Procedure: primary total hip arthroplasty
Active Comparator: HIP STEM SL PLUS MIA
control group

Intervention: Procedure: primary total hip arthroplasty

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2014

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01435850

Other Study ID Numbers ^ICMJE

D10056-2-F

Has Data Monitoring Committee

Not Provided

Responsible Party

Smith & Nephew Orthopaedics AG

Study Sponsor ^ICMJE

Smith & Nephew Orthopaedics AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Henri Migaud, MD, Pr.

University Hospital

Information Provided By

Smith & Nephew Orthopaedics AG

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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