A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery

Last updated: June 23, 2017
Sponsor: DePuy International
Overall Status: Terminated

Phase

4

Condition

Joint Injuries

Lupus

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00872794
CT03/29
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: i) Male or female subjects, aged between 18 and 65 years inclusive. ii) Subjects with current indications for standard MoM hip resurfacing arthroplastysuitable for cementless fixation in the acetabulum. These include pain, deformity, and lossof function, which are not responsive to medical treatment. iii) Subjects who are able to give voluntary, written informed consent to participate inthis investigation and from whom consent has been obtained. iv) Subjects, who, in the opinion of the Investigator, are able to understand thisinvestigation, co-operate with the investigational procedures and are willing to return tothe hospital for all the required post-operative follow-ups.

Exclusion

Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that wouldcompromise 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 thatcould affect follow-up care or treatment outcomes. viii) Subjects who have participated in a clinical study with an investigational product inthe last 6 month(s). ix) Subjects who are currently, or have been in the last 12 months, participating in aclinical 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

  1. Subjects who currently have other metallic foreign bodies including trauma productsand joint arthroplasties unless known to be pure titanium, titanium alloy.

  2. Subjects who, in the opinion of the investigator, will possibly require a separatejoint replacement operation within the next two years, including revision operations

Study Design

Total Participants: 50
Study Start date:
November 01, 2003
Estimated Completion Date:
May 31, 2010

Connect with a study center

  • St Augustine's Hospital

    Durban,
    South Africa

    Site Not Available

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