POLARSTEM Cementless Hip Stem

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02648152

D10070-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 218 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design