Status:
TERMINATED
A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study wi...
Eligibility Criteria
Inclusion
- i) Male or female subjects between 18 and 70 years of age.
- 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 agree to return to the hospital for all the required post-operative follow-ups.
- iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis.
Exclusion
- i) Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study.
- ii) Women who are pregnant.
- iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect 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 for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip.
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00208455
Start Date
February 1 2005
End Date
February 1 2013
Last Update
June 26 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Asklepios Klinikum
Bad Abbach, Germany
2
Ospedale San Pietro
Rome, Italy
3
Arnau de Vilanova
Valencia, Spain
4
North Bristol NHS Trust
Bristol, United Kingdom