Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12611000819921
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
4/08/2011
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study.
Scientific title
MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study - A prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after hip resurfacing surgery, clinical trial.
Secondary ID [1] 262733 0
Nil
Universal Trial Number (UTN)
U1111-1123-2312
Trial acronym
MITCHEx-11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum metal ion concentration in patients who have had hip replacement or hip resurfacing surgery 270442 0
Condition category
Condition code
Musculoskeletal 270589 270589 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an extension study which recruits patients that formerly took place in the MITCH Metal Ions Study which followed patients for 2 years after their hip surgery by looking at blood metal ion concentrations, quality of life, hip functionality/pain.

The ACTR Number for the MITCH Metal Ions Study is ACTRN12608000193370. This study took patients that required a total hip replacement, or just hip re-surfacing and used either the MITCH modular system or MITCH resurfacing system respectively. Both used 'metal-on-metal' components. The study aimed to analysed chrome and cobalt blood chemistry and compare the results to activity levels. The patients were followed at 6 weeks, 6 months, 12 months and 24 months post-operatively. At each visit the patient had a blood test, an X-ray and completed 3 x questionnaires relating to health, function of hip and quality of life.

This extension study aims to continue following these patients at 3 and 5 years after their original surgery. This is an observational study which is both retrospective and prospective. The retrospective data will come from the aforementioned MITCH Metal Ions Study.
Intervention code [1] 267080 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269330 0
To determine long-term serum metal ion levels in patients completing the MITCH Metal Ions Study, at 3 and 5 years. This will be assessed by analysing blood samples taken at the 3 and 5 year visits.
Timepoint [1] 269330 0
3 years and 5 years post-operatively.
Secondary outcome [1] 279395 0
To compare radiographics at 3 and 5 years and identify whether any correlation exists with metal ion levels. This objective will be achieved by utilizing the following instrument at the 3 and 5 year visits:
AP and ML X-rays.
Timepoint [1] 279395 0
3 and 5 years post-operatively.
Secondary outcome [2] 279453 0
To compare hip pain at 3 and 5 years and identify whether any correlation exists with metal ion levels. This objective will be achieved by utilizing the following instrument at the 3 and 5 year visits:
Harris Hip Score and SF-12 Survey
Timepoint [2] 279453 0
3 and 5 years post-operatively.
Secondary outcome [3] 279454 0
To compare hip function at 3 and 5 years and identify whether any correlation exists with metal ion levels. This objective will be achieved by utilizing the following instrument at the 3 and 5 year visits:
Harris Hip Score, UCLA Activity Score and SF-12 Survey
Timepoint [3] 279454 0
3 and 5 years post-operatively.
Secondary outcome [4] 279455 0
To compare quality of life at 3 and 5 years and identify whether any correlation exists with metal ion levels. This objective will be achieved by utilizing the following instrument at the 3 and 5 year visits:
Harris Hip Score, UCLA Activity Score and SF-12 Survey
Timepoint [4] 279455 0
3 and 5 years post-operatively.

Eligibility
Key inclusion criteria
1. Patients who meet the success criteria for MITCH Metal Ions Study and are invited by Investigator to participate
2. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
3. Patients who are capable of, and have signed the study specific, HREC-approved informed consent form

Success criteria for patients to be eligible for MITCHEx-11 Study:
1. Patients who completed surgery with MITCH THR resurfacing or modular
2. Patients who completed follow-up at 6-month time point in MITCH Metal Ions Study
3. No protocol deviation or serious adverse event leading to termination from the MITCH Metal Ions study.
4. No voluntary withdrawal from the MITCH Metal Ions study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who have had or require revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint
2. Patients who have had their MITCH TRH revised to a non-MITCH THR
3. Patients taking health supplements with Cr or Co.
4. Patients with metal implants other than the MITCH TRH
5. Patients who are immunologically suppressed or receiving steroids in excess of normal physiological requirements.
6. Patients with a cognitive impairment, an intellectual disability or a mental illness

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
4/09/2011
Date of last participant enrolment
Anticipated
31/07/2013
Actual
30/06/2013
Date of last data collection
Anticipated
Actual
16/03/2015
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4327 0
2099
Recruitment postcode(s) [2] 6155 0
2065 - Wollstonecraft

Funding & Sponsors
Funding source category [1] 267550 0
Commercial sector/Industry
Name [1] 267550 0
Stryker South Pacific
Country [1] 267550 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] 266589 0
None
Name [1] 266589 0
Address [1] 266589 0
Country [1] 266589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269512 0
Hawksbury Human Research Ethics Committee of Northern Sydney Central Coast Health
Ethics committee address [1] 269512 0
The Research Office
Level 2, Building 51
Royal North Shore Hospital
Pacific Highway, St Leonards NSW 2065
Ethics committee country [1] 269512 0
Australia
Date submitted for ethics approval [1] 269512 0
12/08/2011
Approval date [1] 269512 0
24/07/2012
Ethics approval number [1] 269512 0

Summary
Brief summary
The aim of the study is to analyse the serum metal ions for the MITCH system throughout the steady state phase after surgery. This study extends the current MITCH Metal Ions Study from an endpoint of 2 years to a longer post-operative time point of 5 years. The results will be used as a direct comparison to other research completed for hip resurfacing components on the Australian Market. This study also forms part of the post-market surveillance activities of the Sponsor.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32948 0
Dr Len Walter
Address 32948 0
Peninsula Orthopaedics Research Institute
Level 1, 812 Pittwater Road
Deey Why 2099
NSW
Country 32948 0
Australia
Phone 32948 0
+61 2 9984 9888
Fax 32948 0
+61 2 9972 2639
Email 32948 0
[email protected]
Contact person for public queries
Name 16195 0
Natascha Millard
Address 16195 0
Stryker South Pacific
8 Herbert Street, St Leonards
NSW 2065
Country 16195 0
Australia
Phone 16195 0
+61 2 9467 1073
Fax 16195 0
Email 16195 0
[email protected]
Contact person for scientific queries
Name 7123 0
Natascha Millard
Address 7123 0
Stryker South Pacific
8 Herbert Street, St Leonards
NSW 2065
Country 7123 0
Australia
Phone 7123 0
+61 2 9467 1073
Fax 7123 0
Email 7123 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.