Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001115820
Ethics application status
Approved
Date submitted
15/10/2012
Date registered
18/10/2012
Date last updated
28/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multi-Centre Study to Test the Safety and Performance of the DePuy AVN Cage in Treating Osteonecrosis of the Hip
Scientific title
A Prospective, Single-arm, Uncontrolled, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy AVN Cage Prosthesis for the Treatment of Avascular Necrosis of the Hip.
Secondary ID [1] 281398 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avascular Necrosis of the Hip 287636 0
Condition category
Condition code
Musculoskeletal 287970 287970 0 0
Other muscular and skeletal disorders
Surgery 287980 287980 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AVN Cage Prosthesis - a metal cage that is inserted into the femoral head and is then packed with bone graft material. Skin to skin time is approximately 45 minutes and the prosthesis is intended to remain in situ permanently.
Intervention code [1] 285881 0
Treatment: Surgery
Intervention code [2] 285891 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288180 0
Lack of disease progression as measured by x-rays, CT & MRI
Timepoint [1] 288180 0
2 years
Primary outcome [2] 288181 0
No requirement for further surgery
Timepoint [2] 288181 0
2 years
Secondary outcome [1] 299555 0
Survivorship of the AVN Cage as defined by revision of the AVN Cage for any reason and analysed by Kaplan-Meier plots.
Timepoint [1] 299555 0
1, 2, 3, 4 and 5 years

Eligibility
Key inclusion criteria
Skeletally mature
ARCO stage II osteonecrosis of the femoral head
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acetabular degeneration
Had previous surgery for AVN in the affected hip
Deformity in the upper femur
Drug or alcohol abuse or condition that could affect follow-up
Pregnancy
Nickel or metal sensitivity
Local or systemic infection
Surgical treatment on contralateral hip in last 3 months or planned for within 3 months after surgery
Paget's or Charcot's disease
Osteonecrotic lesion considered to be at limited risk of progression

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
There are subtleties in the ARCO staging process that make it difficult to ascertain a patient's definite eligibility.
Date of first participant enrolment
Anticipated
17/10/2012
Actual
6/11/2012
Date of last participant enrolment
Anticipated
Actual
5/03/2014
Date of last data collection
Anticipated
Actual
20/04/2016
Sample size
Target
77
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 4601 0
Hong Kong
State/province [1] 4601 0
Country [2] 4602 0
Thailand
State/province [2] 4602 0

Funding & Sponsors
Funding source category [1] 286155 0
Commercial sector/Industry
Name [1] 286155 0
DePuy International Ltd
Country [1] 286155 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
DePuy International Ltd
Address
1, White Rose Office Park
Millshaw Park Lane
Leeds
LS11 0BG
Country
United Kingdom
Secondary sponsor category [1] 284964 0
Commercial sector/Industry
Name [1] 284964 0
Johnson& Johnson Medical Pty. Ltd.
Address [1] 284964 0
1-5 Khartoum Road
North Ryde
NSW 2113
Country [1] 284964 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288213 0
St Vincent's Hospital (Melbourne) Human Research Ethics Committee-D
Ethics committee address [1] 288213 0
Level 6, de Lacy Building
St Vincent's Hospital,
390 Victoria Street,
Darlinghurst,
NSW 2010
Ethics committee country [1] 288213 0
Australia
Date submitted for ethics approval [1] 288213 0
Approval date [1] 288213 0
21/10/2011
Ethics approval number [1] 288213 0
1 1 9 /1 1

Summary
Brief summary
The purpose of this study is to determine whether the DePuy AVN Cage is a safe and effective treatment for avascular necrosis of the hip in patients for whom the disease has not yet progressed beyond a certain stage. Each surgery will be considered a success if 2 years after surgery the disease has not progressed to the next stage and if the patient has no need for further surgery on that hip.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34834 0
Prof Peter Chiu
Address 34834 0
Room 216, New Clinical Building,
Queen Mary Hospital,
102 Pok Fu Lam Rd
Pokfulam,
Hong Kong
Country 34834 0
Hong Kong
Phone 34834 0
+852 (2255) 4259
Fax 34834 0
Email 34834 0
[email protected]
Contact person for public queries
Name 18081 0
Dr Sue Kemp, Ph. D.
Address 18081 0
DePuy Synthes
St. Anthony’s Road
Leeds
LS11 8DT
United Kingdom
Country 18081 0
United Kingdom
Phone 18081 0
+44 113 387 7804
Fax 18081 0
Email 18081 0
[email protected]
Contact person for scientific queries
Name 9009 0
Dr Sue Kemp, Ph.D.
Address 9009 0
DePuy Synthes
St. Anthony’s Road
Leeds
LS11 8DT
United Kingdom
Country 9009 0
United Kingdom
Phone 9009 0
+44 113 387 7804
Fax 9009 0
Email 9009 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.