POLARSTEM Retrospective Multicenter Study

NCT02680340 | Completed DMC

• 1 other identifier: 14-4562-05
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 5

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

Conditions

Osteoarthritis

Keywords

Total Hip Arthroplasty THA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of subjects with revision of any components for any reason

  date of surgery until 10 years Follow Up

• Standard radiographic assessment at least at 10 years

  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

  at 10 years Follow Up

• Merle D'Aubigné and Postel (MAP) at least at 10-year assessment

  pre-operative and at 10 years Follow Up

• Adverse Events

  through study completion, an average of 10 years

Interventions

Total Hip Arthroplasty PROCEDURE

Patients who had a primary THA between 2002 and 2005

Also known as: Polarstem primary THA

Eligibility Criteria

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

You may qualify if:

• Subject required and received primary total hip arthroplasty between 2002 and 2005.
• 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.
• Subject received the non-cemented POLARSYSTEM (POLARSTEM™ Ti/HA in combination with POLARCUP™).
• Subject was aged between 18 and 75 at time of surgery.
• Signed Informed Consent (ICF).

You may not qualify if:

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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (5)

Clinique la Parisière

Bourg-de-Péage, 26300, France

Location

Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69300, France

Location

Centre Hospitalier du Forez- Montbrison

Montbrison, 42605, France

Location

Centre Hospitalier de Montélimar

Montélimar, 26200, France

Location

Clinique du Renaison

Roanne, 42300, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Arnaud Fiquet, Dr. med.

  Infirmerie Protestante de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: February 11, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)