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Completed

NCT Number: NCT02680340

POLARSTEM Retrospective Multicenter 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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique la Parisière, Bourg-de-Péage, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Total Hip Arthroplasty

Procedure

Patients who had a primary THA between 2002 and 2005

Other names: Polarstem primary THA

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

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

    Time frame: pre-operative and at 10 years Follow Up

  5. Adverse Events

    Time frame: through study completion, an average of 10 years

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Official study title

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

Acronym: PR

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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