POLARSTEM Cementless Hip Stem

Smith & Nephew, Inc.218 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

218

Conditions

Osteoarthritis

Interventions

Total Hip ArthroplastyDEVICE

Total Hip Arthroplasty using Cementless version of the POLARSTEM

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

St. Elisabeth Hospital, Orthopedics and Rheumatology

Bochum, Germany

University Marburg, Orthopedics and Rheumatology

Marburg, Germany

Kantonsspital Aarau, Orthopedics

Aarau, Switzerland

Outcomes

Primary Outcomes

Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM

Overall survivorship of the Cementless Version of the POLARSTEM pre-operatively, 3 months, 12 months, 12 months, 36 months, 60 months, and 120 months by Kaplan-Meier estimate with overall hip survivorship defined as the time between date of treatment and date of revision for any reason.

Time frame: Pre-operatively, 3 months, 12 months, 36 months, 60 months, and 120 months

Secondary Outcomes

Harris Hip Score (HHS)

The HHS measured function, range of motion (ROM), and pain sub-scores that are combined to indicate total dysfunction on a numerical scale from 0 to 100, with a higher score indicating less dysfunction (i.e., a better outcome). Reported scores for the HHS utilized the following grading: * \<70 = poor * 70 to 80 = fair * 80 to 90 = good * 90 to 100 = excellent

Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale

WOMAC Pain subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range of 0 to 20. Higher WOMAC scores indicate worse pain (i.e., worse outcome) and lower scores indicate less pain (i.e., a better outcome).

Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale

WOMAC Stiffness subscale is a subset of the Hip Disability and Osteoarthritis Outcome Score (HOOS) with a range from 0 to 8 with a higher score indicating a worse outcome and a low score indicating a better outcome.

Time frame: Pre-operative, 3 Months, 12 Months, 36 Months, 60 Months, 120 Months

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale

Data from ClinicalTrials.gov

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