Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000788673
Ethics application status
Approved
Date submitted
4/07/2023
Date registered
19/07/2023
Date last updated
19/07/2023
Date data sharing statement initially provided
19/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A monocentric, retrospective and prospective, non-randomised, clinical survey to evaluate Mpact cup performance 5 years following Total hip arthroplasty
Scientific title
A monocentric, retrospective and prospective, non-randomised, clinical survey to evaluate Mpact cup performance 5 years following Total hip arthroplasty
Secondary ID [1] 310000 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 330512 0
Total Hip Arthroplasty 330513 0
Condition category
Condition code
Musculoskeletal 327365 327365 0 0
Osteoarthritis
Surgery 327366 327366 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient’s quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.

During the last decade, a new titanium porous coating was introduced to improve the osteointegration for the uncemented acetabular component. A high surface friction and scratch-fit allows for secure initial fixation, whereas the high porosity ensures bony ingrowth thus providing secondary long term stability. With higher porosity in respect with standard coatings, for any given percentage filling, a greater volume of bone is present within the porous surface, thus giving a proportionate increase in interface strength.

Mpact cup is a modular hemispherical press-fit acetabular shell with an external Titanium porous coating called Ti-Growth (Medacta commercial name: MectaGrip).

The primary objective of this study is to evaluate Mpact clinical and radiological performance through the modified Harris Hip Score (MHSS) and standard x-rays. 50 patients who had underwent a THA with a Mpact cup will be recruited during the 5-year follow-up visit to be observed up to 5-years post-surgery. Retrospectively collected data includes surgical details such as device implanted and complications that occurred, and postoperative clinical and radiological assessments. MHSS at the 5year follow-up will be collected prospectively which is anticipated to take 10minutes to complete. Radiographic assessments and adverse event reports, if required, will also be completed prospectively.
Intervention code [1] 326431 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335229 0
Mean scores on patient reported outcome questionnaire - Modified Harris Hip Score (HSS) questionnaire to assess the functional capacity of the patient after surgery.
Timepoint [1] 335229 0
6 weeks, 3 months, 1, 2 and 5 years after surgery
Primary outcome [2] 335230 0
Radiological Performance using standard x-rays to assess device status, based on bone fixation and placement.
Timepoint [2] 335230 0
6 weeks, 3 months, 1, 2 and 5 years after surgery
Secondary outcome [1] 423559 0
Incidence of device and/or surgical-associated complications collected from review of medical records such as loosening and wear.
Timepoint [1] 423559 0
5 years after surgery

Eligibility
Key inclusion criteria
• Patient who underwent THA from March 2011 till November 2011.
• Patient who received a Mpact cup.
• Patient who agrees to comply with the study protocol.
• Patient who gave their consent to the treatment of his/her clinical data
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Minor patient
• Pregnant or breast feeding woman
• Patient who is not able to provide consent for participation in the study.
• Patient refusing data collection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
All categorical variables collected will be presented by a distribution of frequencies and percentages; quantitative variables by the mean, standard deviation, minimum and maximum value. Comparison between mean values will be performed using t-test and considering a significant p value <0.05.
The Kaplan-Meier curve will be used in order to calculate the survival rate of the device.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/01/2017
Date of last participant enrolment
Anticipated
Actual
4/12/2017
Date of last data collection
Anticipated
Actual
4/12/2017
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314178 0
Commercial sector/Industry
Name [1] 314178 0
Medacta Australia Pty Ltd
Country [1] 314178 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country
Australia
Secondary sponsor category [1] 316103 0
None
Name [1] 316103 0
Address [1] 316103 0
Country [1] 316103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313307 0
St Vincent's Hospital (Melbourne)
Ethics committee address [1] 313307 0
Ethics committee country [1] 313307 0
Australia
Date submitted for ethics approval [1] 313307 0
Approval date [1] 313307 0
09/12/2016
Ethics approval number [1] 313307 0

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

Contacts
Principal investigator
Name 127678 0
Dr John O'Donnell
Address 127678 0
Hip Arthroscopy Australia, 21 Erin Street, Richmond VIC 3121
Country 127678 0
Australia
Phone 127678 0
+61 3 9421 6133
Fax 127678 0
Email 127678 0
[email protected]
Contact person for public queries
Name 127679 0
Selin Kulaga
Address 127679 0
Medacta Australia, Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country 127679 0
Australia
Phone 127679 0
+61 1300 361 790
Fax 127679 0
Email 127679 0
[email protected]
Contact person for scientific queries
Name 127680 0
John O'Donnell
Address 127680 0
Hip Arthroscopy Australia, 21 Erin Street, Richmond VIC 3121
Country 127680 0
Australia
Phone 127680 0
+61 3 9421 6133
Fax 127680 0
Email 127680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.