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, Ceramic-on-Ceramic
Brief summary
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a ceramic-on-ceramic 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.
Interventions
A cementless acetabular cup with ceramic 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 effect 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. vii) Subjects undergoing a simultaneous bilateral hip operation. viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation. ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship at the five-year period | 5yrs |
Secondary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship calculations | Annually |
| Harris Hip Score | 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery |
| Radiographic analysis | 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery |
| Oxford Hip score | 3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs post-surgery |
Countries
Czechia
Outcome results
None listed