The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle Acetabular Cup System in primary total hip arthroplasty.The secondary objectives of this investigation are to evaluate the clinical and patient outcomes associated with the Pinnacle Acetabular Cup System in primary total hip arthroplasty and to evaluate the long term survivorship of the Pinnacle Acetabular Cup System over 15 years.

Condition	Intervention	Phase
Osteoarthritis, Hip	Device: Pinnacle Acetabular System	Phase IV

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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 a cementless acetabular component and a metal on polyethylene bearing.

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) Subjects undergoing simultaneous bilateral hip operation. iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant. vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.

Please refer to this study by ClinicalTrials.gov identifier  NCT00208429

Study chairs or principal investigators

Michael Borroff, B.Sc. M.Sc.,  Study Director,  DePuy International Ltd   

Study ID Numbers:  CT0340
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00208429
Health Authority: United Kingdon: MHRA
ClinicalTrials.gov processed this record on 2005-09-27