Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment osteoarthritis
Sponsor Smith & Nephew, Inc.
Start date March 2009
End date April 2021
Trial size 225 participants
Trial identifier NCT02648152, D10070

Summary

Multicenter observational study to validate that the POLARSTEM™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Long term survivorship of Polarstem
time frame: 10 years Follow Up after surgery

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Patient has no general medical contraindication to surgery - Informed consent to participate in the MCO signed by the patient - Routine radiographic assessment is possible - Patient is likely to comply with study follow-up requirements - Primary total hip replacement (THR) to the affected side, unilateral or bilateral Exclusion Criteria: - Previously failed endoprosthesis and /or THR components in relevant hip - History of infection in the affected joint; systemic infections - Grossly insufficient femoral or acetabular bone stock in the involved hip - Charcot joint disease or other severe neurosensory deficit - Severe spinal disorders - Age of patient at date of surgery > 75 years - High comorbidity - Cemented acetabular cup

Additional Information

Official title Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM
Principal investigator Turgay Efe, Dr.med.
Description The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the POLARSTEM™. Efficacy evaluations: - Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, Hip disability and osteoarthritis outcome score (HOOS) [7, 8], an extension of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). - Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration Safety evaluations: - Intra- and perioperative device-related adverse events (AE) and complications up to discharge - Postoperative AE up to 10 years
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..