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Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
DePuy ASR™ Hip System
DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Resurfacing, Metal-on-Metal, Large Heads, XL Head, ASR - osteoarthritis (primary)

Eligibility Criteria

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

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 Exclusion Criteria for DePuy ASR™:

i) Subjects with proven significant osteoporosis and poor bone quality.

ii) Subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.

iii) Subjects whose anatomical CCD angle is below 120°.

iv) Subjects who have undergone irradiation of the affected hip.

Sites / Locations

  • University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
  • Znojmo Hospital
  • Coxa, Hospital for Joint Replacement
  • Klinikum der Universität zu
  • Elverum Hospital
  • Hospital Curry Cabral
  • Kant. Spital Sursee-Wolhusen
  • Royal Berkshire Hospital, UK

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Resurfacing system

Large Metal-on-Metal Total Hip Replacement

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the five-year time-point

Secondary Outcome Measures

Annual Kaplan-Meier survivorship calculations
Harris Hip Score
Radiographic analysis
Oxford Hip Score
UCLA Activity Score
Hip Outcome Score
EuroQol EQ-5D

Full Information

First Posted
March 30, 2009
Last Updated
August 3, 2016
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00872547
Brief Title
Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement
Official Title
Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

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, Resurfacing, Metal-on-Metal, Large Heads, XL Head, ASR - osteoarthritis (primary)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Resurfacing system
Arm Title
2
Arm Type
Active Comparator
Arm Description
Large Metal-on-Metal Total Hip Replacement
Intervention Type
Device
Intervention Name(s)
DePuy ASR™ Hip System
Intervention Description
Resurfacing system
Intervention Type
Device
Intervention Name(s)
DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Intervention Description
Large Metal-on-Metal Total Hip Replacement
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculated at the five-year time-point
Time Frame
5yrs
Secondary Outcome Measure Information:
Title
Annual Kaplan-Meier survivorship calculations
Time Frame
Annually
Title
Harris Hip Score
Time Frame
3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Title
Radiographic analysis
Time Frame
3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Title
Oxford Hip Score
Time Frame
3mths, 6mths and annually post-surgery
Title
UCLA Activity Score
Time Frame
3mths, 6mths and annually post-surgery
Title
Hip Outcome Score
Time Frame
3mths, 6mths and annually post-surgery
Title
EuroQol EQ-5D
Time Frame
3mths, 6mths and annually post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria for DePuy ASR™: i) Subjects with proven significant osteoporosis and poor bone quality. ii) Subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable. iii) Subjects whose anatomical CCD angle is below 120°. iv) Subjects who have undergone irradiation of the affected hip.
Facility Information:
Facility Name
University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
City
Graz
Country
Austria
Facility Name
Znojmo Hospital
City
Znojmo
Country
Czech Republic
Facility Name
Coxa, Hospital for Joint Replacement
City
Tampere
Country
Finland
Facility Name
Klinikum der Universität zu
City
Köln
Country
Germany
Facility Name
Elverum Hospital
City
Elverum
Country
Norway
Facility Name
Hospital Curry Cabral
City
Lisboa
State/Province
Curry Cabral
Country
Portugal
Facility Name
Kant. Spital Sursee-Wolhusen
City
Wolhusen
Country
Switzerland
Facility Name
Royal Berkshire Hospital, UK
City
Reading
State/Province
Berkshire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement

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