Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000193370
Ethics application status
Approved
Date submitted
9/04/2008
Date registered
11/04/2008
Date last updated
3/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after hip resurfacing surgery.
Scientific title
Prospective consecutive series of 40 patients undergoing metal on metal hip resurfacing surgery, assessing the change in metal ions over time.
Secondary ID [1] 252397 0
.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis (OA) of the hip 3025 0
Condition category
Condition code
Musculoskeletal 3177 3177 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study includes 2 types of interventions. Group one will undergo hip resurfacing surgery using the Stryker 'MITCH' resurfacing system. The 'MITCH' resurfacing system is in 2 parts - an acetabular cup, and a femoral cap which sits over the femoral head.
Group two will undergo surgery using the Stryker 'MITCH' modular system with a Stryker 'Accolade' stem. The 'MITCH' modular system is in 3 parts - an acetabular cup, a femoral component which replaces the femoral head and an 'Accolade' stem which sits in the femur and supports the whole construct.
Surgery for group one and group two will take approximately 2 hours.
Both groups will be followed for 2 years.
Intervention code [1] 2768 0
Treatment: Devices
Comparator / control treatment
The results of this study will be compared to current literature.
Control group
Active

Outcomes
Primary outcome [1] 4063 0
1. Analyse serum chrome and Cobalt blood chemistry
2. Compare the pathology results to activity results
Timepoint [1] 4063 0
Pre-op, post-op (6 weeks, 6 months, 12 months and 24 months)
Secondary outcome [1] 6834 0
1. Quality of life Patient Outcomes
Timepoint [1] 6834 0
Pre-op, post-op (6 weeks, 6 months, 12 months and 24 months)

Eligibility
Key inclusion criteria
MITCH hip resurfacing group: * Diagnosed with degenerative osteoarthritis * Good femoral bone stock * Good acetabular bone quality * Templated for size 48-56 femoral head * Minimal femoral bone deformity: <1/3 of the femoral head with cysts * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow up * patients who are capable of, and have given, informed consent to their participation in the study MITCH modular head hip arthrosplasty group: * diagnosed with degenerative osteoarthritis or avascular necrosis * Good acetabular bone quality * Templated for a size 56 acetabulum and 46-54 femoral head * Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow up * Patients who are capable of, and have given informed consent to their participation in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
MITCH hip resurfacing group:
* Patients with renal impairment
* Patients with primary avascular necrosis
* Patients that have any other metallic implants
* Patients that may be taking health supplements with Chrome or Cobalt
* Patients with osteoporosis
* metabolic disorders that may affect chromium and cobalt metabolism

MITCH modular head hip arthroplasty group:
* patients with renal impairment
* patients that have any other metallic implants
* patients that may be taking health supplements with Chrome or Cobalt
* metabolic disorders that may affect Chromium and Cobalt metabolism

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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2008
Actual
14/07/2008
Date of last participant enrolment
Anticipated
Actual
5/11/2010
Date of last data collection
Anticipated
Actual
8/09/2012
Sample size
Target
40
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3281 0
Commercial sector/Industry
Name [1] 3281 0
Stryker South Pacific
Country [1] 3281 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker South Pacific
Address
8 Herbert Street, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 2934 0
None
Name [1] 2934 0
Address [1] 2934 0
Country [1] 2934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5268 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 5268 0
Ethics committee country [1] 5268 0
Australia
Date submitted for ethics approval [1] 5268 0
Approval date [1] 5268 0
26/02/2008
Ethics approval number [1] 5268 0
07/040MAT

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

Contacts
Principal investigator
Name 28512 0
Dr Len Walter
Address 28512 0
Mater Hospital
Rocklands Road
North Sydney, 2060
NSW , Australia

Postal Address:
PO BOX 958
North Sydney, 2059
NSW, Australia
Country 28512 0
Australia
Phone 28512 0
61 2 9900 7300
Fax 28512 0
Email 28512 0
[email protected]
Contact person for public queries
Name 11669 0
Alissa Connelly
Address 11669 0
Clinical Research Associate II, Stryker Australia, 8 Herbert St, ST LEONARDS NSW 2065
Country 11669 0
Australia
Phone 11669 0
61 2 9467 1075
Fax 11669 0
61 2 9467 1132
Email 11669 0
[email protected]
Contact person for scientific queries
Name 2597 0
Alissa Connelly
Address 2597 0
Stryker Australia, 8 Herbert St, ST LEONARDS NSW 2065
Country 2597 0
Australia
Phone 2597 0
61 2 9467 1075
Fax 2597 0
61 2 9467 1132
Email 2597 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.