POLARSTEM Retrospective Multicenter Study (PR)

February 21, 2017 updated by: Smith & Nephew Orthopaedics AG

Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study

The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.

The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in France. 502 subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. Subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.

Study Type

Observational

Enrollment (Actual)

502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bourg de Peage, France, 26300
        • Clinique la Parisière
      • Caluire Et Cuire, France, 69300
        • Infirmerie Protestante de Lyon
      • Montbrison, France, 42605
        • Centre Hospitalier du Forez- Montbrison
      • Montélimar, France, 26200
        • Centre Hospitalier de Montélimar
      • Roanne, France, 42300
        • Clinique du Renaison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

502 male and female subjects who have undergone THA with POLARSTEM™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years.

Description

Inclusion Criteria:

  1. Subject required and received primary total hip arthroplasty between 2002 and 2005.
  2. Subject received the POLARSTEM™ Ti/HA unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes.
  3. Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
  4. Subject was aged between 18 and 75 at time of surgery.
  5. Signed Informed Consent (ICF).

Exclusion Criteria:

  1. Subject received the cemented POLARSTEM™.
  2. Previously failed endoprosthesis and/or THR components in relevant hip.
  3. Medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral stem revision rate at 10 years for any reason
Time Frame: since surgery until 10 years Follow Up
Long term cumulative femoral stem revision rate of Polarstem will be evaluated in 502 subjects
since surgery until 10 years Follow Up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with revision of any components for any reason
Time Frame: date of surgery until 10 years Follow Up
Long-term cumulative revision rate of the cup will be evaluated in 502 subjects
date of surgery until 10 years Follow Up
Standard radiographic assessment at least at 10 years
Time Frame: date of surgery and at 10 years Follow Up
radiographic evaluation on x-rays to assess the osseointegration and orientation of cup and stem, heterotopic ossification, signs of radiolucent lines, osteolysis, atrophy and hypertrophy
date of surgery and at 10 years Follow Up
Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO
Time Frame: at 10 years Follow Up
at 10 years Follow Up
Merle D'Aubigné and Postel (MAP) at least at 10-year assessment
Time Frame: pre-operative and at 10 years Follow Up
pre-operative and at 10 years Follow Up
Adverse Events
Time Frame: through study completion, an average of 10 years
through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smith & Nephew Orthopaedics AG

Investigators

  • Principal Investigator: Arnaud Fiquet, Dr. med., Infirmerie Protestante de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-4562-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Total Hip Arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe