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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status

Terminated

Phase

Phase 4

Locations

South Africa

Study Type

Interventional

Intervention

DePuy ASR™ Hip System

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Conservative, Metal on Metal, Resurfacing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St Augustine's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DePuy ASR Hip System

Arm Description

A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty.

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship at two years

Secondary Outcome Measures

UCLA Activity Score

WOMAC Score

Activity Assessment.

Kaplan-Meier survivorship calculation

Harris Hip Score

Radiographic analysis

Metal ion analysis in whole blood

Bone mineral density (DEXA)

Full Information

NCT ID

NCT00872794

First Posted

March 19, 2009

Last Updated

June 23, 2017

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00872794

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

DePuy discontinued this product in 4Q 2009.At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study.

Study Start Date

November 2003 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis

Keywords

Hip, Conservative, Metal on Metal, Resurfacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DePuy ASR Hip System

Arm Type

Other

Arm Description

A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty.

Intervention Type

Device

Intervention Name(s)

DePuy ASR™ Hip System

Intervention Description

A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty.

Primary Outcome Measure Information:

Title

Kaplan-Meier survivorship at two years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

UCLA Activity Score

Time Frame

Annually

Title

WOMAC Score

Time Frame

Annually

Title

Activity Assessment.

Time Frame

Annually

Title

Kaplan-Meier survivorship calculation

Time Frame

Annually

Title

Harris Hip Score

Time Frame

pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery

Title

Radiographic analysis

Time Frame

pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery

Title

Metal ion analysis in whole blood

Time Frame

3mths, 6mths, 1yr, 2yrs and 5 yrs post-surgery

Title

Bone mineral density (DEXA)

Time Frame

3mths, 1yr, 2yrs and 5 yrs post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

St Augustine's Hospital

City

Durban

Country

South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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