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

NCT ID: NCT01435850

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

HIP STEM SL PLUS

study group

Group Type: SHAM_COMPARATOR

primary total hip arthroplasty

Intervention Type: PROCEDURE

All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.

HIP STEM SL PLUS MIA

control group

Group Type: ACTIVE_COMPARATOR

primary total hip arthroplasty

Intervention Type: PROCEDURE

All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.

Interventions

primary total hip arthroplasty

All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.

Intervention Type: PROCEDURE

Other Intervention Names

SL-PLUS, SL-PLUS MIA, Lateralized hip stem

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew Orthopaedics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henri Migaud, MD, Pr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Locations

Hopital Salengro, Service d'Orthopédie C

Lille, , France

Countries

France

Other Identifiers

D10056-2-F

Identifier Type: -

Identifier Source: org_study_id