A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
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Purpose
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.
DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from November 2010 to allow for the completion of the 5 year follow up assessments.
Please note that subsequent 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/CON079157 and http://www.depuy.com/countries_list.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis. |
Device: DePuy ASR™ Hip System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Single-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy ASR™ Hip in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty |
- Kaplan-Meier survivorship at two years [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- UCLA Activity Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- WOMAC Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Activity Assessment. [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Kaplan-Meier survivorship calculation [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Metal ion analysis in whole blood [ Time Frame: 3mths, 6mths, 1yr, 2yrs and 5 yrs post-surgery ] [ Designated as safety issue: No ]
- Bone mineral density (DEXA) [ Time Frame: 3mths, 1yr, 2yrs and 5 yrs post-surgery ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | November 2003 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
-
Device: DePuy ASR™ Hip System
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Male or female subjects, aged between 18 and 65 years inclusive.
ii) Subjects with current indications for standard MoM hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.
iii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
iv) 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.
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 proven significant osteoporosis and poor bone quality.
iii) Subjects with compromised renal function.
iv) Subjects with proven metal sensitivity.
v) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.
vi) Women who are pregnant.
vii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
viii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
ix) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
x) Subjects who are currently involved in any injury litigation claims.
Additional Exclusion Criteria for Subjects Undergoing Blood Analysis
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium, titanium alloy.
- Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations
Contacts and Locations More Information
No publications provided
| Responsible Party: | Carol Picker, Senior Clinical Research Associate, DePuy International Ltd |
| ClinicalTrials.gov Identifier: | NCT00872794 History of Changes |
| Other Study ID Numbers: | CT03/29 |
| Study First Received: | March 19, 2009 |
| Last Updated: | September 1, 2011 |
| Health Authority: | South Africa: South African Medical Association |
Keywords provided by DePuy International:
|
Hip Conservative Metal on Metal Resurfacing |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Collagen Diseases Femoral Fractures Hip Dislocation, Congenital Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Fractures, Bone Wounds and Injuries Leg Injuries Musculoskeletal Abnormalities Congenital Abnormalities Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 22, 2013