The primary objective of this investigation is to determine whether the post-operative rehabilitation and mobilisation of subjects undergoing a minimally invasive surgical procedure is superior to those undergoing conventional surgery in total hip arthroplasty. The secondary objective of this investigation is to evaluate the post-operative pain levels, wound condition, subject activity, operative blood loss and date of safe discharge in subjects undergoing minimally invasive or conventional surgery. In addition, the long-term survivorship and clinical and radiographic outcomes will be evaluated in both treatment groups.

Condition	Intervention	Phase
Osteoarthritis, Hip	Device: DePuy MI System	Phase IV

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 75 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 with a primary diagnosis of osteoarthritis. v) Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.

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, or extend their time to discharge beyond that required for their hip replacement surgery.

ii) Women who are pregnant. iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims. vi) Subjects with a Body Mass Index (BMI) > 30. vii) Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.

viii) Subjects requiring a simultaneous bilateral total hip arthroplasty. ix) Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty.

Please refer to this study by ClinicalTrials.gov identifier  NCT00208416

Study chairs or principal investigators

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

Study ID Numbers:  CT0229
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00208416
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2005-09-27