Avascular Necrosis, Collagen Disorders, Congenital Hip Dysplasia, Nonunion of Femoral Fractures, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Slipped Capital Femoral Epiphysis, Traumatic Femoral Fractures
Conditions
Keywords
Hip, Cementless
Brief summary
The purpose of this study is to monitor the performance of the Summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
Interventions
DEVICESummit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement
Sponsors
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship calculated at the five-year time point | 5yrs post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip score | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery |
| Oxford score | 6mths and Annually post-surgery |
| Kaplan-Meier survivorship calculations | Annually |
| Thigh pain analysis | 6mths and Annually post-surgery |
| Radiological analysis | pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery |
| UCLA activity rating | 6mths and Annually post-surgery |
Countries
China, Hong Kong, Italy, New Zealand, South Korea
Outcome results
None listed