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

NCT01435850 | Completed Phase 4 DMC

• 1 other identifier: D10056-2-F
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis

Keywords

hip arthroplasty; primary stability; secondary stability; EBRA

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (2)

• Oxford Hip Score

  24 months

• Harris Hip Score

  24 months

Study Arms (2)

HIP STEM SL PLUS

SHAM COMPARATOR

study group

Procedure: primary total hip arthroplasty

HIP STEM SL PLUS MIA

ACTIVE COMPARATOR

control group

Procedure: primary total hip arthroplasty

Interventions

primary total hip arthroplasty PROCEDURE

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

Also known as: SL-PLUS, SL-PLUS MIA, Lateralized hip stem

HIP STEM SL PLUS; HIP STEM SL PLUS MIA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (1)

Hopital Salengro, Service d'Orthopédie C

Lille, 59037, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Henri Migaud, MD, Pr.

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 19, 2011
• Study Start: April 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

FR (1)