A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis.
Device: Pinnacle Acetabular System
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement|
- Kaplan-Meier survivorship calculated at the five-year time-point. [ Time Frame: 5 yrs post surgery ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Kaplan-Meier survivorship [ Time Frame: Annually ] [ Designated as safety issue: Yes ]