Polarstem Cementless Hip Stem

Osteoarthritis Clinical Trial

— Polarstem  

Official title:

Multicenter Clinical Observation Using the Cementless Version of the POLARSTEM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648152
• Other study ID #: D10070
• Status: Completed
• Start date: March 2009
• Est. completion date: November 2020

Study information

• Verified date: December 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Osteoarthritis
Total Hip Arthroplasty

Locations

Country	Name	City	State
Germany	St. Elisabeth Hospital, Orthopedics and Rheumatology	Bochum
Germany	University Marburg, Orthopedics and Rheumatology	Marburg
Switzerland	Kantonsspital Aarau, Orthopedics	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term survivorship of Polarstem	Long-term survivorship will be calculated according to Kaplan-Meier with stem revision due to any reason as endpoint	10 years Follow Up after surgery