POLARSTEM Retrospective Multicenter Study

Osteoarthritis Clinical Trial

— PR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680340
• Other study ID #: 14-4562-05
• Status: Completed
• Phase: N/A
• First received: January 5, 2016
• Last updated: February 21, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Total Hip Arthroplasty
Patients who had a primary THA between 2002 and 2005

Locations

Country	Name	City	State
France	Clinique la Parisière	Bourg de Peage
France	Infirmerie Protestante de Lyon	Caluire Et Cuire
France	Centre Hospitalier du Forez- Montbrison	Montbrison
France	Centre Hospitalier de Montélimar	Montélimar
France	Clinique du Renaison	Roanne

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

France, 

Outcome

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