Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000003774
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
10/01/2022
Date last updated
10/01/2022
Date data sharing statement initially provided
10/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A post-market clinical investigation to evaluate clinical and patient-reported outcomes following a total hip arthroplasty surgery with Trinity™ Dual Mobility System.
Scientific title
A post-market clinical investigation to evaluate clinical and patient-reported outcomes following a total hip arthroplasty surgery with Trinity™ Dual Mobility System in patients with hip osteoarthritis - Prospective Group
Secondary ID [1] 303844 0
CSP2017-09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Hip Arthroplasty
 321384 0
Osteoarthritis 322722 0
Condition category
Condition code
Musculoskeletal 319159 319159 0 0
Osteoarthritis
Surgery 322167 322167 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a post-market, multi-centre, non-comparative, open label prospective interventional study. The study aims to measure the performance and the safety of Trinity™ Dual Mobility System in patients undergoing Hip Replacement Surgery. It will also measure the whole blood metal ions (Cobalt, Chromium and Titanium) levels in these patients receiving the TrinityTM Dual Mobility System at a minimum 2-year follow-up following the surgery.
In this study the eligible patients who will undergo hip replacement surgery will be identified by the Orthopaedic surgeon from his patient database. The patients will be a given an information form to read and sign. Following the signature, the patients will be assessed for suitability for participating in the study. Once they fit the criteria, they will be enrolled in the study. After enrolment the patients will complete some assessments and a X Ray. Medical History will be collected and physical health assessment will be done. They will also complete 3 quality-of-life questionnaires to assess their quality of life before the surgery. Those patients who will be participating in the blood subgroup analysis will be giving a blood sample. The assessments before surgery will take approximately 2-4 hours.
On the day of the surgery the participants will receive the following components for the hip surgery - TrinityTM Dual Mobility System in combination with a Corin Femoral Stem. The Trinity™ Dual Mobility System is not ‘new’ and is a commonly used hip prosthesis in Australia. It has been approved for use by the Australian Therapeutic Goods Administration since 2017 and over 1800 procedures have been performed using the Trinity™ Dual Mobility in Australia. The surgery will be completed by the Orthopaedic surgeons and will take about 2 hours. Following the surgery the patient will do another X Ray while at the hospital before discharge.
Following the surgery, the patient will complete a few follow up visits over a span of 5 years where the safety and performance of the Trinity DM cup will be measured by various assessments like blood tests, X Ray, physical exams and the quality-of-life questionnaires. Some of these follow up visits will be completed at the Orthoapedic surgeon’s office and some of these visits can be completed from home where the patients will be completing the questionnaires on their smart phone or computer. Throughout the study any adverse event that the patient may be experiencing will be reported to the Orthopaedic surgeon and his study team. The follow up study visits will take approximately 1-2 hours depending on the nature of the visit. The study team will send timely reminders to the participant ahead of the follow up visit.
Intervention code [1] 320150 0
Treatment: Devices
Intervention code [2] 321087 0
Treatment: Surgery
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327041 0
Patient-reported disability post-total hip arthroplasty assessed using the Oxford Hip Score (OHS),
Timepoint [1] 327041 0
Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.
Secondary outcome [1] 393579 0
Assessment of survival rate of the Trinity™ Dual Mobility System after total hip replacement 5 years after surgery by Standard X Ray
Timepoint [1] 393579 0
Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.
Secondary outcome [2] 393580 0
Measurement of metal ions (Co, Cr and Ti) levels from whole blood at a minimum of 2 years after surgery.
Timepoint [2] 393580 0
Pre-operative blood sample (within 4 weeks of surgery), and post-operatively at 2 years and 5 years.
Secondary outcome [3] 401909 0
Patient-reported disability post-total hip arthroplasty assessed using EQ-5D-5L, Hip disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS Junior), Pain Visual Analogue Score (VAS)
Timepoint [3] 401909 0
Pre-operative (within 4 weeks of surgery), and post-operatively at 6 weeks 6months, 1 year, 2 years and 5 years.

Eligibility
Key inclusion criteria
The individual has signed a Patient Informed Consent Form (PICF), specific to this clinical investigation, and approved by the Human Research Ethics Committee;
Both genders;
Age greater than or equal to 18 years old;
The individual clinically qualifies for Trinity™ Dual Mobility System with a Corin Femoral Stem based on physical examination and medical history.
The individual is willing to comply with the required protocol for follow-up visits.

Additional inclusion criteria for patients participating in the metal-ion analysis:
Willing to provide blood samples.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects under guardianship;
Subjects with any physical or psychological condition which would impair clinical investigation participation;
Having previous or current hip infection and or a history of metal sensitivity;
Having abnormal renal function
Any patient pregnant or with plans to become pregnant during the course of the clinical investigation.

Additional exclusion criteria for patients participating in the metal-ion analysis (from the prospective group):
Presence of any metal-containing implant in the body outside of the oral cavity
Taking chromium supplements.
Participants who are not willing or able to provide a blood sample

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
Prospective component - A minimum of 100 hips will be enrolled into the prospective component according to the selection criteria. This sample size will be sufficient to demonstrate a clinically relevant change of 5 OHS points at 2 years after surgery.

For the subset of patients providing whole blood samples for metal ion levels measurement, a sample size of n=52 will be sufficient to detect a small to medium effect size (Cohen’s d=0.4) at a significance level of 0.05 and a power of 0.8 (based on single-group repeated measurement analysis).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/04/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19047 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 33595 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 308239 0
Commercial sector/Industry
Name [1] 308239 0
Corin Australia Pty Limited
Country [1] 308239 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Corin Australia Pty Limited
Address
17 Bridge Street
Pymble
NSW2073
Country
Australia
Secondary sponsor category [1] 309033 0
None
Name [1] 309033 0
Address [1] 309033 0
Country [1] 309033 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308221 0
Bellberry Ethics committee
Ethics committee address [1] 308221 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 308221 0
Australia
Date submitted for ethics approval [1] 308221 0
04/12/2020
Approval date [1] 308221 0
02/03/2021
Ethics approval number [1] 308221 0

Summary
Brief summary
This is a Post-market, multi-centre, non-comparative, open label study . The study aims to measure the performance and the safety of Trinity™ Dual Mobility System in patients who will receive Trinity™ Dual Mobility System during Total Hip Arthroplasty (THA). A subset of these patients will also provide blood sample for measuring whole blood metal ions (Co, Cr and Ti) levels in patients receiving the TrinityTM Dual Mobility System.

In the prospective component, patients who are eligible for the THA that will receive the TrinityTM Dual Mobility System in combination with a Corin Femoral Stem. These patients will complete follow up visits over a span of 5 years where the safety and performance of the Trinity DM cup will be measured by quality of life questionnaires. Those patients that are deemed suitable will be invited to provide a blood sample for the measurement of Cobalt, Chromium and Titanium levels. The metal ion levels in the blood of the participants will be monitored over time to determine any presence of metal ions (Co, Cr and Ti) above the local laboratory normal range in whole blood.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109974 0
Prof Michael OSullivan
Address 109974 0
North Sydney Orthopaedic & Sports Medicine Centre
Suite 2 The Mater Clinic, 3-9 Gillies St
Wollstonecraft NSW 2065
Country 109974 0
Australia
Phone 109974 0
+61 2 9409 0544
Fax 109974 0
Email 109974 0
mo'[email protected]
Contact person for public queries
Name 109975 0
Dr Lucy Salmon
Address 109975 0
North Sydney Orthopaedic & Sports Medicine Centre
Suite 2 The Mater Clinic, 3-9 Gillies St
Wollstonecraft NSW 2065
Country 109975 0
Australia
Phone 109975 0
+61 2 9409 0544
Fax 109975 0
Email 109975 0
[email protected]
Contact person for scientific queries
Name 109976 0
Ms Anandita Roy
Address 109976 0
Clinical Research Manager
Corin Australia
17 Bridge Street
Pymble NSW 2073
Country 109976 0
Australia
Phone 109976 0
+61294977400
Fax 109976 0
Email 109976 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
Data collected from the trial will be used for regulatory submission and research publication purposes. Individual study results such as blood, X Ray will be shared with the patients as needed.


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.