Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000781741
Ethics application status
Approved
Date submitted
20/05/2013
Date registered
12/07/2013
Date last updated
12/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Post Recall Clinical Follow-up of patients previously treated with the DePuy Articular Surface Replacement Hip System.
Scientific title
Clinical Follow-up of ASR patients Post -Recall

A 5 year Post Recall Clinical Follow-up study to collect longitudinal data from patients previously treated with the DePuy Articular Surface Replacement Hip System
Secondary ID [1] 282494 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical outcomes post hip replacement 289142 0
Condition category
Condition code
Musculoskeletal 289698 289698 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For 5 years post hip replacement, each study participant will be observed and monitored for the rate of revision, adverse events/complications (local tissue reaction and metal ion levels in serum or whole blood) and patient reported outcome measures (PROMs), to determine potential predictors for these outcomes.
A web-based data entry system managed will collect data from multiple sites internationally to document the radiographic and clinical outcomes of the DePuy Articular Surface Replacement Hip systems. All enrolled patients will be monitored with annual clinical exams and serum or whole blood levels of cobalt and chromium. All data will be uploaded to the central database when the exams are performed.
Intervention code [1] 287151 0
Not applicable
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289580 0
To monitor the outcomes of standard clinical care in terms of rate of revision and complications.
A complication is any untoward medical occurrence in a participant who has received the Articular Surface Replacement (ASR) Hip System. It does not necessarily have to have a causal relationship with the Articular Surface Replacement (ASR) Hip System and can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a device, whether or not considered related to this device. An example is the detection of increased level of cobalt and / or chromium ion levels measured in serum or whole blood
Timepoint [1] 289580 0
Annually for 5 years post hip replacement
Secondary outcome [1] 303697 0
Determinmation of patient recorded Outcome Measures via the Harris Hip Score, Case Mix Indicator, EQ-5D score and UCLA questionnaires.
Timepoint [1] 303697 0
At the completion of data collection
Secondary outcome [2] 303698 0
Determination of the acetabular cup position from radiographs.
Timepoint [2] 303698 0
At the completion of data collection
Secondary outcome [3] 303699 0
Determine the incidence of radiolucencies
Timepoint [3] 303699 0
At the completion of data collection
Secondary outcome [4] 303700 0
Measure cobalt and chromium ion serum levels.
Timepoint [4] 303700 0
At the enroment in the study and each annual vist for 5 years post hip replacement surgery.
Secondary outcome [5] 303701 0
Observe any adverse local tissue reaction that may be attributable to the Articular Surface Replacement (ASR) Hip System
Timepoint [5] 303701 0
Annually for 5 years post hip replacement surgery.

Eligibility
Key inclusion criteria
1.Any patient with on-label use of the ASR-XL or ASR component system currently implanted. Manual addition of antibiotics to cement during arthroplasty is not considered to be off-label use.
2.Able to provide informed consent at those sites where this is required by the institution’s institutional review (IRB) or ethics committee (EC).
3.Able to return for follow-up annually for 5 years.
4.Able to complete the required patient reported outcome measures.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Any patient with off-label use indications for the ASR-XL or ASR component system.
2.Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
3.Patients with difficulty in comprehending the Informed Consent Form for any reason.
4.The patient refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Primary Outcome
The following Data Analyses will be completed on the Primary Outcome.

Implant Failure/Survival Rate (time-to-event, revision surgery, from date of surgery)
1.Revision rate estimates and survival curves will be estimated via Kaplan-Meier curves
2.For comparison across groups: log-rank tests (ex: difference in survival between genders)
3.For comparison to quantitative covariates: Cox proportional hazard models (ex: association of survival to age of patient).

Secondary Outcomes
The following Data Analyses will be completed on the Secondary Outcomes.

Adverse Local Tissue Reaction (ALTR)
1.The following summary statistics will be provided for 3 groups of patients after each follow-up visit:
a.Number and proportion of patients with follow-up for each annual visit or later
b.Cumulative number and proportion of patients with ALTR: those that experienced ALTR in this interval or any previous interval
c.Cumulative number and proportion of patients with no diagnosis of ALTR up to each annual visit
2.Logistic Regression Models will be used to estimate rates and the relationship to covariates after each annual follow-up visit
3.Generalized Linear Mixed Models for binary data will be used to estimate the change in rates over time and how this relates to possible covariates

Metal Ion Levels in Serum or Whole Blood: Cobalt and Chromium
1.Summary Statistics will be provided after each follow-up visit (sample size, means, medians, standard deviation, and range).
2.Linear Regression Models will be used to estimate means and the relationship to covariates after each annual follow-up visit.
3.Generalized Linear Mixed Models for quantitative data will be used to estimate the change in outcomes over time and how this relates to possible covariates

Note: measures are expected to be right-skewed, so a median or Wilcoxon-type regression methods may be used.

Incidence of Radiolucencies
1.Logistic Regression Models will be used to estimate rates and the relationship to covariates after each annual follow-up visit
2.Generalized Linear Mixed Models for binary data will be used to estimate the change in outcomes over time and how this relates to possible covariates.

Four Surveys: UCLA, Harris Hip Score, Case Mix Indicator, and EQ-5D score
1.Linear Regression Models will be used to estimate means and the relationship to covariates after each annual follow-up visit
2.Generalized Linear Mixed Models for binary data will be used to estimate the change in outcomes over time and how this relates to possible covariates.

Determination of cup position from AP and shoot through radiographs (Martell technique)
1.The incidence of migration will be provided, where migration is determined radiographically.
2.Logistic Regression will be used to estimate rates and the relationship to other covariates at each follow-up visit.
3.Changes in cup position will be monitored with Generalized Linear Mixed Models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 1009 0
Sportsmed SA Hospital - Stepney
Recruitment postcode(s) [1] 6883 0
5069 - Stepney
Recruitment postcode(s) [2] 7013 0
2150 - Parramatta
Recruitment postcode(s) [3] 7014 0
3107 - Templestowe Lower

Funding & Sponsors
Funding source category [1] 287281 0
Commercial sector/Industry
Name [1] 287281 0
DePuy Orthopaedics, Inc.
Country [1] 287281 0
United States of America
Primary sponsor type
Hospital
Name
Massachusetts General Hospital
Address
55 Fruit Street Boston Massachusetts MA 02114
United States of America
Country
United States of America
Secondary sponsor category [1] 286038 0
Other Collaborative groups
Name [1] 286038 0
The International Muscukloskeletal Research Institute
Address [1] 286038 0
The General Repatriation Hospital
216 Daws Road
Daw Park
SA 5042
Country [1] 286038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289262 0
Belberry Limited
Ethics committee address [1] 289262 0
Ethics committee country [1] 289262 0
Australia
Date submitted for ethics approval [1] 289262 0
Approval date [1] 289262 0
12/04/2013
Ethics approval number [1] 289262 0
2012-09-1077-A-1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40006 0
Prof Stephen Graves
Address 40006 0
Director, Arthroplasty Service & Research, Department of Orthopaedics, Repatriation General Hospital, Daws Road, Daw Park SA 5041
Country 40006 0
Australia
Phone 40006 0
+61 08 82769666
Fax 40006 0
Email 40006 0
[email protected]
Contact person for public queries
Name 40007 0
Slav Lerner
Address 40007 0
Harris Orthopaedic Laboratory
Massachusetts General Hospital
Fruit St., Jackson 1126
Boston, MA 02114

Country 40007 0
United States of America
Phone 40007 0
+1-617-726-3607
Fax 40007 0
Email 40007 0
[email protected]
Contact person for scientific queries
Name 40008 0
Slav Lerner
Address 40008 0
Harris Orthopaedic Laboratory
Massachusetts General Hospital
Fruit St., Jackson 1126
Boston, MA 02114
Country 40008 0
United States of America
Phone 40008 0
+1-617-726-3607
Fax 40008 0
Email 40008 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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