A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip 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 Arthroplasty, Replacement, Hip, Conservative, Anatomic, Cementless
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Asklepios Klinikum
- Ospedale San Pietro
- Arnau de Vilanova
- North Bristol NHS Trust
Arms of the Study
Arm 1
Other
DePuy Proxima™ Hip
A short, anatomic, cementless femoral component for use in total hip arthroplasty