Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000093684
Ethics application status
Approved
Date submitted
15/12/2022
Date registered
27/01/2023
Date last updated
17/05/2023
Date data sharing statement initially provided
27/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical, radiographic and patient-reported outcomes using MobiliT™ cup with ECiMa™ insert in primary total hip arthroplasty surgery.
Scientific title
Clinical, radiographic and patient-reported outcomes using MobiliT™ cup with ECiMa™ insert in primary total hip arthroplasty surgery.
Secondary ID [1] 307338 0
CSP2021-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 326628 0
Total Hip Arthroplasty 326629 0
Condition category
Condition code
Musculoskeletal 323874 323874 0 0
Osteoarthritis
Surgery 325542 325542 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Post-Market Clinical Follow (PMCF) study will evaluate clinical performance and safety outcomes of primary total hip arthroplasty surgeries using MobiliT™ ECiMa cup and Paragon™ stem over a ten-year period.
Participants will be selected for recruitment into the study from the general population of patients requiring a dual mobility total hip arthroplasty surgery and considered suitable to be implanted with MobiliT™ cup and Paragon™ stem (Corin Ltd). After the surgery, participants will be required to return for follow up visits and radiographic controls at specific timepoints and complete questionnaires for a period of 10 years.

The MobiliT™ ECiMa is a monobloc dual mobility system that includes a metal shell combined with a size specific polyethylene insert. This system offers two articulating surfaces in the same joint space, one between the shell and the insert, the other between the insert and the femoral head. The shell is made of stainless steel and articulates with either an Ultra High Molecular Weight Polyethylene (UHMWPE) or HXLPE (Highly Cross Linked Polyethylene) with Vitamin E (ECiMa™) polyethylene insert. Only the ECiMa insert is available in the Australian market and will be assessed in combination with the cementless MobiliT™ cup in this Post Market Clinical Follow Up (PMCF) study.
This prospective PMCF study is being initiated to collect performance and functional results of dual mobility procedures performed in primary THA surgery using the MobiliT cup and the ECiMa (highly crosslinked UHMWPE with Vitamin E. All the devices used in this study are approved by the Therapeutic Goods Administration and is listed on the prostheses list.
In this study, the patients eligible for total hip replacement surgery will be identified by the Orthopaedic surgeon from his patient database. The patients will be 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 clinical assessments including measuring Harris Hip Score and taking an X-ray of the hip. Medical history will be collected, and physical examination will be done. They will also complete 3 quality of life questionnaires to assess their quality of life before the surgery. The assessments before surgery will take 2-4 hours.
On the day of the surgery, participants will receive MobiliT™ cup with either Paragon™ or Taperfit stem. The choice of the stem will be determined by the Orthopaedic surgeon based on clinical need.
The surgery will be completed by experienced Orthopaedic surgeons who have received training on the products and will take about 2-3 hours. Following the surgery, the patient will do another X-ray while at the hospital before discharge.
Following the surgery, the patient will complete 6 follow up visits and 2 telephone visits over a span of 10 years, where the safety and performance of the MobiliT™ cup will be measured via various assessments such as physical examinations, X-Rays and quality-of-life questionnaires. Some of these visits can be completed from the Orthopaedic surgeon’s clinic and some can be completed from home, where the patient can complete the questionnaires from 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] 323773 0
Treatment: Surgery
Intervention code [2] 325078 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331679 0
Participant Quality of Life will be assessed by Harris Hip Score (HHS)
Timepoint [1] 331679 0
Preoperative (within 4 weeks of surgery), and post-operatively at 3 months, 1 year, 2 years [primary timepoint], measured post operatively at 5 year, 7 year and 10 years for those that attend clinic (optional)
Primary outcome [2] 333384 0
Participant Quality of Life will be assessed by Oxford Hip Score
Timepoint [2] 333384 0
Preoperative (within 4 weeks of surgery), and post-operatively at 3 months, 1 year, 2 years [primary timepoint], measured post operatively at 5 year, 7 year and 10 years for those that attend clinic (optional)
Primary outcome [3] 333385 0
Participant Quality of Life will be assessed by EQ-5D-5L
Timepoint [3] 333385 0
Preoperative (within 4 weeks of surgery), and post-operatively at 3 months, 1 year, 2 years [primary timepoint], measured post operatively at 5 year, 7 year and 10 years for those that attend clinic (optional)
Secondary outcome [1] 410775 0
Incidence of intraoperative and post-operative adverse events (hip, medical device or surgery related) up to 10 years post surgery. The surgeon will report any adverse events during the surgery in case report forms.
Timepoint [1] 410775 0
Adverse Events will be assessed before the surgery, monitored continuously during surgery, and monitored at each follow-up visits occurring within 0-6 days, at 3 months, 1 year, 2 years, 4 years, 5 years, 7 years, 9 years and 10 years post-operatively.
Secondary outcome [2] 410776 0
Revision rate of the devices will be assessed by reporting by investigator, by accessing medical records, by collecting data from the National Joint Replacement Registry at 0-6 days, 3 months, 1 year, 2 years, 4 years, 5 years, 7 years, 9 years, 10 years post surgery.
Timepoint [2] 410776 0
up to 10 years post surgery
Secondary outcome [3] 410777 0
Kaplan-Meier survival rate up after surgery to 10-year follow up will be assessed by accessing medical records, by collecting data from the National Joint Replacement Registry.
Timepoint [3] 410777 0
up to 10 years follow up post surgery
Secondary outcome [4] 410781 0
Patient’s satisfaction after surgery using the 4-point Likert-type scale at each time-point.
Timepoint [4] 410781 0
3 months, 1 year, 2 years, , 5 years, 7 years, 10 years post surgery

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.
- Minimum age 18 years old, maximum age of 85 years old.
- The individual clinically qualifies for a dual mobility total hip arthroplasty surgery with MobiliT™ ECiMa cup and Paragon stem based on physical examination and medical history and has been scheduled for surgery.
- The individual is willing to comply with the required protocol for follow-up visits.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals under guardianship.
- Individuals with any physical or psychological condition which would impair clinical investigation participation.
- Individual with current hip infection.
- Any patient pregnant or with plans to become pregnant during the clinical study.
- Individuals who are already enrolled in other clinical studies.

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
Safety/efficacy
Statistical methods / analysis
A minimum of 100 hips will be enrolled into the study according to the selection criteria. This sample size will be sufficient to demonstrate an OHS change over time with an alpha of 0.5 and a power >0.9.

Statistical analyses will be performed when data has been collected for the study population at 2 years and 10 years follow-up.
Descriptive statistics will be provided in summary tables according to the type of variable summarised:
• survivorship will be calculated as Kaplan-Meier analysis with 95% confidence interval.
• quantitative variables will be summarized by using n (sample size), arithmetic mean, standard deviation (SD), median, minimum, and maximum, comparing between follow-ups and baseline values (where applicable).
• categorical variables will be summarized by using frequency count and percent distribution.
Additional analysis may include comparisons of interest across demographic and baseline characteristics.
The analyses will include:
Analysis of primary endpoint:
- Percent change and absolute improvement of OHS will be reported at each follow-up visit compared to pre-op and previous visit(s).
Analysis of secondary endpoints:
- Descriptive analysis of the survival of the devices will be performed using Kaplan-Meier survival curves, including listing of details of revision procedures (reason, time to revision, components revised).
- Hip-/ procedure-/ device- related adverse events will be listed and summarized based on the different mechanisms of classification, such as type of event, timing (operative/post-operative), seriousness and relation with the study devices.
- Postoperative HHS compared to pre-op baseline and previous visits. Percent change and absolute improvement will be reported for total scores and/or sub-scores as appropriate.
- Postoperative EQ-5D-5L compared to pre-op baseline and previous visits. Percent change and absolute improvement will be reported for total scores and/or sub-scores (EQ-VAS) as appropriate.
- Patient’s satisfaction with the results of the surgery and any change to previous visit.
The rates and extent of any radiolucent lines, osteolysis and rates of implant loosening will be reported at specified follow-up time points, as assessed by available radiographs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
16/12/2022
Date of last participant enrolment
Anticipated
17/12/2024
Actual
Date of last data collection
Anticipated
31/10/2034
Actual
Sample size
Target
100
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 40386 0
3084 - Heidelberg
Recruitment postcode(s) [2] 40387 0
3084 - Heidelberg
Recruitment postcode(s) [3] 40388 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 311629 0
Commercial sector/Industry
Name [1] 311629 0
Corin Australia Pty Limited
Country [1] 311629 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Corin Australia Pty Limited
Address
17 Bridge Street Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 314716 0
None
Name [1] 314716 0
Address [1] 314716 0
Country [1] 314716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311085 0
Bellberry Limited
Ethics committee address [1] 311085 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 311085 0
Australia
Date submitted for ethics approval [1] 311085 0
10/06/2022
Approval date [1] 311085 0
24/10/2022
Ethics approval number [1] 311085 0
2022-06-600-A

Summary
Brief summary
This Post-Market Clinical Follow (PMCF) study will evaluate clinical performance and safety outcomes of primary total hip arthroplasty surgeries using MobiliT™ cup and Paragon™ stem over a ten-year period.
Participants will be selected for recruitment into the study from the general population of patients requiring a dual mobility total hip arthroplasty surgery and considered suitable to be implanted with MobiliT™ cup and Paragon™ and Taperfit stem (Corin Ltd). After the surgery, participants will be required to return for follow up visits and radiographic controls at specific timepoints and complete questionnaires for a period of 10 years.
This PMCF prospective study is being initiated to collect performance and functional results of dual mobility procedures performed in primary THA surgery using the MobiliT™ cup and the ECiMa (highly crosslinked UHMWPE with Vitamin E) insert that received the CE mark at the end of 2020 and was recently approved by the TGA in 2022 for dual mobility procedures in primary THA surgery.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119890 0
Mr Peter Gard
Address 119890 0
Peter Gard Private Consulting, Suite 3.01, 10 Martin St., Heidelberg, VIC., 3084
Country 119890 0
Australia
Phone 119890 0
+61 3 9457 3612
Fax 119890 0
Email 119890 0
pjgard@me.com
Contact person for public queries
Name 119891 0
Ms Anandita Roy
Address 119891 0
Corin Australia PTY Limited
17 Bridge Street
Pymble
NSW 2073
Country 119891 0
Australia
Phone 119891 0
+61 2 9097 7400
Fax 119891 0
Email 119891 0
anandita.roy@coringroup.com
Contact person for scientific queries
Name 119892 0
Ms Anandita Roy
Address 119892 0
Corin Australia PTY Limited
17 Bridge Street
Pymble
NSW 2073
Country 119892 0
Australia
Phone 119892 0
+61 2 9097 7400
Fax 119892 0
Email 119892 0
anandita.roy@coringroup.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17322Study protocol    384208-(Uploaded-15-12-2022-01-21-24)-Study-related document.pdf



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.