Avascular Necrosis, Collagen Disorders, Congenital Hip Dysplasia, Nonunion of Femoral Fractures, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Slipped Capital Femoral Epiphysis, Traumatic Femoral Fractures
Conditions
Keywords
Hip, Cementless, Metal-on-Metal
Brief summary
The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-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. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Interventions
DEVICEPinnacle Acetabular Cup System
A cementless acetabular cup with metal liner for use in total hip replacement
Sponsors
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
i) Male or female subjects, aged between 18 and 70 years inclusive. ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
Exclusion criteria
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects undergoing revision hip replacement. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims. Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship calculated at the 5 year time point. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood | Annually |
| Harris Hip score | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery |
| Oxford Hip score | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery |
| Radiological analysis | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery |
| Metal ion analysis in whole blood | pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery |
Countries
Italy, United Kingdom
Outcome results
None listed