Clinical trial NCT02680340: POLARSTEM Retrospective Multicenter Study
Official title: Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Total Hip Arthroplasty THA
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Femoral stem revision rate at 10 years for any reason
timeFrame: since surgery until 10 years Follow Up
Secondary outcomes:
measure: Number of subjects with revision of any components for any reason
timeFrame: date of surgery until 10 years Follow Up
measure: Standard radiographic assessment at least at 10 years
timeFrame: date of surgery and at 10 years Follow Up
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS) at least at 10-year assessment as patient reported outcome (PRO
timeFrame: at 10 years Follow Up
measure: Merle D'Aubigné and Postel (MAP) at least at 10-year assessment
timeFrame: pre-operative and at 10 years Follow Up
measure: Adverse Events
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Bourg de Peage
country: France
facility: Clinique la Parisière
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante de Lyon
city: Montbrison
country: France
facility: Centre Hospitalier du Forez- Montbrison
city: Montélimar
country: France
facility: Centre Hospitalier de Montélimar
city: Roanne
country: France
facility: Clinique du Renaison
Study officials:
affiliation: Infirmerie Protestante de Lyon
name: Arnaud Fiquet, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: