Polarstem Cementless Hip Stem

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT02648152
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term survivorship of Polarstem	10 years Follow Up after surgery	Long-term survivorship will be calculated according to Kaplan-Meier with stem revision due to any reason as endpoint

Trial Locations

Locations (3)

University Marburg, Orthopedics and Rheumatology; 🇩🇪 Marburg, Germany

St. Elisabeth Hospital, Orthopedics and Rheumatology; 🇩🇪 Bochum, Germany

Kantonsspital Aarau, Orthopedics; 🇨🇭 Aarau, Switzerland