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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00208377




Registration number
NCT00208377
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
26/06/2017

Titles & IDs
Public title
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
Scientific title
Prospective Multi-Centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-Term Performance of the DePuy ASR Hip System in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty
Secondary ID [1] 0 0
CT01/21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Osteoarthritis 0 0
Post-traumatic Arthritis 0 0
Collagen Disorders 0 0
Avascular Necrosis 0 0
Nonunion of Femoral Fractures 0 0
Congenital Hip Dysplasia 0 0
Slipped Capital Femoral Epiphysis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Skin 0 0 0 0
Other skin conditions
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - DePuy ASR Hip System

Other: DePuy ASR Hip System - A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty


Treatment: Devices: DePuy ASR Hip System
A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier survivorship calculated annually
Timepoint [1] 0 0
Annually
Secondary outcome [1] 0 0
UCLA Activity Score
Timepoint [1] 0 0
3 months, 6 months and then annually
Secondary outcome [2] 0 0
WOMAC Score
Timepoint [2] 0 0
3 months, 6 months and then annually
Secondary outcome [3] 0 0
Activity Assessment
Timepoint [3] 0 0
3 months, 6 months and then annually
Secondary outcome [4] 0 0
Harris Hip Score
Timepoint [4] 0 0
3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [5] 0 0
Radiographic analysis
Timepoint [5] 0 0
pre-discharge, 3mths, 1yr, 2 yrs, 5yrs, 10yrs and 15yrs post-surgery
Secondary outcome [6] 0 0
Metal ion analysis in whole blood
Timepoint [6] 0 0
3mths, 1yr, 2yrs and 5yrs post surgery
Secondary outcome [7] 0 0
Bone mineral density (DEXA)
Timepoint [7] 0 0
pre-discharge, 3mths, 1yr, 2yrs and 5yrs post-surgery

Eligibility
Key inclusion criteria
i) Male or female subjects, aged between 18 and 65 years inclusive.

ii) Subjects with current indications for standard metal-on-metal (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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
228
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sportsmed SA - Stepney
Recruitment postcode(s) [1] 0 0
- Stepney
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Puettlingen
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
DePuy International
Address
Country

Ethics approval
Ethics application status

Summary
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
December 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00208377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00208377