Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000203257
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
8/02/2018
Date last updated
31/01/2019
Date data sharing statement initially provided
31/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of initial total hip replacement using a cementless hip implant that has been coated with a bio-active material.
Scientific title
Effectiveness of a porous titanium and hydroxyapatite plasma-sprayed short stem in total hip arthroplasty.
Secondary ID [1] 293951 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 306449 0
Condition category
Condition code
Musculoskeletal 305537 305537 0 0
Osteoarthritis
Surgery 305575 305575 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary total hip replacement with an uncemented femoral stem. The intervention is the hip replacement surgery which will be carried out by a suitably qualified and experienced orthopaedic surgeon. The intervention will be delivered once only for each participant and will take place in an operating theatre within a hospital setting
Intervention code [1] 300216 0
Treatment: Surgery
Intervention code [2] 300235 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304668 0
Micro-motion of the prosthesis within the bone. This is measured by RSA x-ray analysis.
Timepoint [1] 304668 0
Three years post surgery
Secondary outcome [1] 342727 0
Quality of Life as measured with EQ-5D-5L questionnaire
Timepoint [1] 342727 0
6 weeks, 6 months, 1 year, 2 years, 3 years post surgery
Secondary outcome [2] 342833 0
Clinical outcomes as measured with Harris Hip Score questionnaire
Timepoint [2] 342833 0
6 weeks, 6 months, 1 year, 2 years, 3 years post surgery

Eligibility
Key inclusion criteria
Participants with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented femoral stem as determined jointly by the surgeon and the patient
Age - 75 years or less
Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up period
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with rheumatoid arthritis
Patients with a history of active infection
Patients with conditions or medications associated with osteoporosis or osteopenia
Pregnant women or those seeking to become pregnant

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
Efficacy
Statistical methods / analysis
Intention to treat analysis will be performed with exclusion of those whose post-surgery follow up visit (six week time-point) will not be carried out. The end-point of the study cohort will be compared to a known value previously published in literature. The hypothesis being tested is that the anticipated subsidence incidence (micro movement) with the study femoral stem will be 2.0% compared to 6.3% of subsidence incidence published in literature.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9942 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 9943 0
Norwest Private Hospital - Bella Vista
Recruitment postcode(s) [1] 18755 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 18756 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 298579 0
Commercial sector/Industry
Name [1] 298579 0
MAC Surgical
Country [1] 298579 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MAC Surgical
Address
6 Roger Street
BROOKVALE NSW 2100
Country
Australia
Secondary sponsor category [1] 297734 0
None
Name [1] 297734 0
Address [1] 297734 0
Country [1] 297734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299545 0
Sydney Local Health District - RPA Zone
Ethics committee address [1] 299545 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
Ethics committee country [1] 299545 0
Australia
Date submitted for ethics approval [1] 299545 0
04/12/2017
Approval date [1] 299545 0
31/05/2018
Ethics approval number [1] 299545 0

Summary
Brief summary
This is a prospective, multi-centre, clinical study using a product that has been registered for use in Australia by the TGA. The primary purpose of the study is to measure micro-movement of a cementless total hip replacement implant within the bone at timepoints up to three years. The micro-movement (if any) will be measured using X-Rays. 222 participants will be recruited and will be followed up for a period of three years. Quality of Life will also be analysed using two questionnaires.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80798 0
Dr Munjed Al Muderis
Address 80798 0
Suite G3B
Norwest Private Hospital
9 Norbrik Drive
BELLA VISTA NSW 2153
Country 80798 0
Australia
Phone 80798 0
+61 2 8882 9011
Fax 80798 0
Email 80798 0
reception@almuderis.com.au
Contact person for public queries
Name 80799 0
Dr Mark Gillies
Address 80799 0
Medical Device Research Australia Pty Ltd
Unit 26
45-51 Huntley Street
ALEXANDRIA NSW 2015
Country 80799 0
Australia
Phone 80799 0
+61 2 9011 5211
Fax 80799 0
Email 80799 0
mark.g@mdresearch.com.au
Contact person for scientific queries
Name 80800 0
Mr Mark Gillies
Address 80800 0
Medical Device Research Australia Pty Ltd
Unit 26
45-51 Huntley Street
ALEXANDRIA NSW 2015
Country 80800 0
Australia
Phone 80800 0
+61 2 9011 5211
Fax 80800 0
Email 80800 0
mark.g@mdresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is not going ahead


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.