A Single Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-ceramic Bearing in Primary Total Hip Replacement
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Cementless, Ceramic-on-Ceramic
Eligibility Criteria
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
Sites / Locations
- St Anne's University Hospital
Arms of the Study
Arm 1
Other
Ceramic-on-Ceramic
Pinnacle™ Acetabular System with ceramic liner