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, Cemented
Brief summary
The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used 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, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.
Interventions
DEVICEC-Stem™ AMT Femoral Component (standard and high off-set variants)
A polished triple tapered cemented 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
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
i) Male or female subjects, aged between 60 and 80 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 undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
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 undergoing revision hip replacement iii) Subjects undergoing simultaneous bilateral hip replacements. iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily. v) Women who are pregnant. vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months. viii) Subjects who are currently involved in any injury litigation claims.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distal migration of the femoral stem at the 5-year time point | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| ML/AP translation and all rotations out to 5 years | pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery |
| Harris Hip score | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery |
| Oxford Hip score | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery |
| Radiological analysis | 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery |
Countries
United Kingdom
Outcome results
None listed