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

This study has been terminated.
(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)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00872547
First received: March 30, 2009
Last updated: September 8, 2014
Last verified: July 2014
  Purpose

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.


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
Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the five-year time-point [ Time Frame: 5yrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Annual Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip Score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: 3mths, 6mths and annually post-surgery ] [ Designated as safety issue: No ]
  • UCLA Activity Score [ Time Frame: 3mths, 6mths and annually post-surgery ] [ Designated as safety issue: No ]
  • Hip Outcome Score [ Time Frame: 3mths, 6mths and annually post-surgery ] [ Designated as safety issue: No ]
  • EuroQol EQ-5D [ Time Frame: 3mths, 6mths and annually post-surgery ] [ Designated as safety issue: No ]

Enrollment: 317
Study Start Date: September 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Resurfacing system
Device: DePuy ASR™ Hip System
Resurfacing system
Active Comparator: 2
Large Metal-on-Metal Total Hip Replacement
Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System
Large Metal-on-Metal Total Hip Replacement

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872547

Locations
Austria
University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
Graz, Austria
Czech Republic
Znojmo Hospital
Znojmo, Czech Republic
Finland
Coxa, Hospital for Joint Replacement
Tampere, Finland
Germany
Klinikum der Universität zu
Köln, Germany
Norway
Elverum Hospital
Elverum, Norway
Portugal
Hospital Curry Cabral
Lisboa, Curry Cabral, Portugal
Switzerland
Kant. Spital Sursee-Wolhusen
Wolhusen, Switzerland
United Kingdom
Royal Berkshire Hospital, UK
Reading, Berkshire, United Kingdom
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00872547     History of Changes
Other Study ID Numbers: CT05/18
Study First Received: March 30, 2009
Last Updated: September 8, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by DePuy International:
Hip
Resurfacing
Metal-on-Metal
Large Heads
XL Head
ASR - osteoarthritis (primary)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Femoral Fractures
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
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
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped

ClinicalTrials.gov processed this record on September 18, 2014