Avascular Necrosis, Collagen Disorders, Congenital Hip Dysplasia, Nonunion of Femoral Fractures, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis, Slipped Capital Femoral Epiphysis
Conditions
Keywords
Hip, Resurfacing, Metal-on-Metal, Large Heads, XL Head, ASR - osteoarthritis (primary)
Brief summary
The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or 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. The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study. Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and http://www.depuy.com/countries\_list.
Interventions
DEVICEDePuy ASR™ Hip System
Resurfacing system
DEVICEDePuy ASR™ XL Head / ASR™ Acetabular Cup System
Large Metal-on-Metal Total Hip Replacement
Sponsors
DePuy International
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: i) Male or female subjects, aged between 18 and 65 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. Inclusion Criteria for DePuy ASR™ Resurfacing system: i) Subjects with primary osteoarthritis indicated for standard MoM hip resurfacing arthroplasty with cementless fixation in the acetabulum. Inclusion Criteria for ASR™ XL Head system: i) Subjects whose bone morphology and bone quality mean that standard MoM hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large MoM bearing are still possible. General
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 with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site. iii) Subjects with proven metal sensitivity. iv) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc. v) Women who are pregnant or who intend to become pregnant within 2 years of surgery. 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 6 month(s). viii) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation. ix) Subjects who are currently involved in any injury litigation claims. x) Subjects who are undergoing corticosteroid treatment. xi) Subjects with active or recent joint sepsis. Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship calculated at the five-year time-point | 5yrs |
Secondary
| Measure | Time frame |
|---|---|
| Harris Hip Score | 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery |
| Radiographic analysis | 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery |
| Oxford Hip Score | 3mths, 6mths and annually post-surgery |
| Annual Kaplan-Meier survivorship calculations | Annually |
| Hip Outcome Score | 3mths, 6mths and annually post-surgery |
| EuroQol EQ-5D | 3mths, 6mths and annually post-surgery |
| UCLA Activity Score | 3mths, 6mths and annually post-surgery |
Countries
Austria, Czechia, Finland, Germany, Norway, Portugal, Switzerland, United Kingdom
Outcome results
None listed