A Multi-centre Study to Assess the Long-term Performance of the Summit™ 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 Hip, Cementless
Eligibility 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 who require primary total hip replacement and are considered suitable for a cementless femoral stem. 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 who have previously undergone a hemi-arthroplasty or total hip arthroplasty. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims.
Sites / Locations
- 2. Ruijin Hospital
- 3. The University of Hong Kong at Queen Mary Hospital
- 1. Ospedale Riuniti Di Bergamo
- 4. Yonsei University College of Medicine
- 5. Middlemore Hospital
Arms of the Study
Arm 1
Other
Summit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement