POLARSTEM Retrospective Multicenter Study

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02680340
• Lead Sponsor: Smith & Nephew Orthopaedics AG

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-11
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of subjects with revision of any components for any reason	date of surgery until 10 years Follow Up	Long-term cumulative revision rate of the cup will be evaluated in 502 subjects
Adverse Events	through study completion, an average of 10 years
Standard radiographic assessment at least at 10 years	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
Merle D'Aubigné and Postel (MAP) at least at 10-year assessment	pre-operative and at 10 years Follow Up
Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO	at 10 years Follow Up

Trial Locations

Locations (5)

Infirmerie Protestante de Lyon; 🇫🇷 Caluire Et Cuire, France

Clinique du Renaison; 🇫🇷 Roanne, France

Clinique la Parisière; 🇫🇷 Bourg de Peage, France

Centre Hospitalier du Forez- Montbrison; 🇫🇷 Montbrison, France

Centre Hospitalier de Montélimar; 🇫🇷 Montélimar, France