Status:
TERMINATED
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis(Primary)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00208416
Start Date
October 1 2005
End Date
November 1 2014
Last Update
May 11 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Rotherham General Hospitals NHS Trust
Rotherham, South Yorkshire, United Kingdom
2
Warwick Hospital NHS Trust
Warwick, United Kingdom