N/A
Completed N=218
POLARSTEM Cementless Hip Stem
Source: ClinicalTrials.gov NCT02648152 ↗Enrolled (actual)
218
Serious AEs
52.3%
Results posted
Jan 2026
Primary outcomePrimary: Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM — 100; 99.6; 99.1; 98.7 percentage of hips
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate: Overall Survivorship of POLARSTEM |
100; 99.6; 99.1; 98.7; 98.7; 98.7 | — |
| SECONDARY Harris Hip Score (HHS) |
48.60; 83.10; 89.20; 89.10; 88.00; 85.30 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Pain Subscale |
11.5; 1.9; 1.5; 1.7; 1.5; 1.0 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Stiffness Subscale |
5.0; 1.6; 1.1; 1.0; 0.7; 0.6 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Physical Function Subscale |
42.1; 10.8; 8.0; 8.0; 9.3; 5.9 | — |
| SECONDARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): Total Score |
58.6; 14.2; 10.5; 10.7; 11.6; 7.4 | — |
| SECONDARY Radiological: Radiolucent Lines |
2; 217; 0; 215; 7; 183 | — |
| SECONDARY Radiological: Osteolysis |
0; 219; 1; 214; 1; 189 | — |
| SECONDARY Radiological: Atrophy |
1; 0; 0; 0; 218; 0 | — |
| SECONDARY Radiological: Hypertrophy |
0; 0; 0; 0; 219; 0 | — |
| SECONDARY Radiological: Loosening of the Implant or Migration |
4; 138; 77; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02648152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.