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Trial registered on ANZCTR


Registration number
ACTRN12622000504718
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
30/03/2022
Date last updated
30/03/2022
Date data sharing statement initially provided
30/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Clinical Investigation to evaluate safety and performance of APEX KNEE Vitamin E, Cold Gamma Irradiated, Mechanically Annealed XLPE (ECiMa) Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis
Scientific title
A Clinical Investigation to evaluate safety and performance of APEX KNEE ECiMa Patella and Tibial Insert components in primary Total Knee Arthroplasty in patients with knee osteoarthritis
Secondary ID [1] 305555 0
Clinical Investigation Plan (CIP) ID: CSP 2020-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 323952 0
Osteoarthritis 325217 0
Condition category
Condition code
Musculoskeletal 321473 321473 0 0
Osteoarthritis
Surgery 322619 322619 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pre-market, multi-centre, non-comparative, open label prospective interventional study. The study aims to evaluate the safety and performance of APEX KNEETM ECiMa Patella and Tibial Insert components in patients undergoing primary Total Knee Arthroplasty.
The Apex Kneeâ„¢ System is a Class III Orthopaedic device intended for use as a primary or revision Total Knee Replacement. It is approved by the Therapeutic Goods Administration and is listed on the prostheses list. The investigational devices, the Apex KneeTM ECiMa Patella and Tibial Insert devices are a line extension to the existing Apex KneeTM System. The investigational devices are composed of Vitamin E blended highly crosslinked polyethylene, introducing a new material option to the current range. This variant has already received approval from the Food and Drug Administration (US) and obtained CE mark (Europe) but do not yet have a listing on the Australian Register of Therapeutic Goods.) hence this study will be conducted under a Clinical Trial Notification (CTN) modification. This study will be a prospective study to evaluate the clinical outcomes and survivorship of the APEX Kneeâ„¢ prosthesis with the ECiMa insert and Patella
In this study, the patients eligible for total knee 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 Range of Motion (ROM) and taking an X-ray of the knee. 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 APEX Kneeâ„¢ system and one of three different types of ECiMa Tibial Inserts: Cruciate retaining, Ultra-Congruent, Posterior Stabilising. The choice of this insert will be determined by the Orthopaedic surgeon based on clinical need.
Not all patients will necessarily receive the ECiMa patella device. Use of the patella component is at the discretion of the surgeons based on the clinical judgment. If the surgeon chooses to resurface the Patella then it will be with the ECiMa Patella device.
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 5 follow up visits over a span of 10 years, where the safety and performance of the ECiMa Patella and Tibial Insert devices will be measured via various assessments such as physical examinations, ROM, 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] 321957 0
Treatment: Surgery
Intervention code [2] 322825 0
Treatment: Devices
Comparator / control treatment
No control group as the Tibial Devices will not be compared.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329248 0
Range of Motion is the measurement of movement around a specific joint. To measure range of movement a goniometer is used. A goniometer is an instrument that measures angle at a joint. Goniometers show degrees of an angle from zero to 180 or 360 degrees. The knee will be measured for fixed flexion and arc of flexion.
Timepoint [1] 329248 0
Preoperative (within 4 weeks of surgery), and post-operatively at 3 months, 1 year, 2 years [primary timepoint], measured at 5 year and 10 years for those that attend clinic (optional)
Secondary outcome [1] 401886 0
The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. Therefore the score is a composite score rather then being considered independently. (The full KOOS questionnaire as opposed to the KOOS JR looks at five different dimensions each scored separately with no single composite score)
Timepoint [1] 401886 0
Preoperative (within 4 weeks of surgery), and at 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.
Secondary outcome [2] 401887 0
Patient Reported Outcome measures using The Oxford Knee Score questionnaire. The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.
Timepoint [2] 401887 0
Preoperative (within 4 weeks of surgery), and at 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.
Secondary outcome [3] 401888 0
Patient Reported Outcome measure using The EQ-5D-5L questionnaire- The questionnaire is made up for two components; health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In the pain/discomfort dimension, it asks how much pain or discomfort they have, and in the anxiety/depression dimension, it asks how anxious or depressed they are. The respondent’s self-rate their level of severity for each dimension using a five-level (EQ-5D-5L) scale.
Timepoint [3] 401888 0
Preoperative (within 4 weeks of surgery), and at 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.
Secondary outcome [4] 407406 0
The survival of the devices will be measured by rate of revisions.
The rate of revision will be assessed by data collected from the patient about any revision and the data collected from Australian Joint Registry for the lifetime of the study i.e 10 years.
The survival of the devices will also be measured by rate of knee-related adverse events.
Timepoint [4] 407406 0
This will be assessed by data collected from the patient for the lifetime of the study i.e 10 years.

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Minimum 18 years of age, maximum age limit 80
2. Be capable of understanding the study requirements and of
providing informed consent
3. Be eligible for a primary total knee replacement with APEX Knee
based on history, physical examination and radiological
evaluation.
4. Agree to attend the research centre for the required postoperative
assessments and radiological evaluation.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
1. Women who are pregnant or breast feeding or plan to become
pregnant during the course of the study.
2. Not willing or unable to return for required follow-up visits or clear
demonstration of likely poor compliance.
3. Any medical condition including current infections that in the
judgement of the investigator would prohibit the patient from
participating in the study
4. Psychiatric or mental disorders, alcohol abuse or other substance
abuse, which in the opinion of the investigator would inhibit
compliance with routine surgical follow-up.
5. The individual has a neuromuscular or neurosensory deficiency
that limits the ability to evaluate the safety and effectiveness of
the device.
6. Previous patellectomy
7. Previous proximal tibial or distal femoral osteotomy.
8. Extra-articular deformity

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
Analyses will be performed when data has been collected for the study population at 2 years, 5 years, and 10 years follow-up. The analyses will include:
Oxford Knee Score and other Patient Reported Outcome Measures (PROMs) completed at each follow-up visit will be compared to pre-op baseline and previous visit(s). Percent change and absolute improvement will be reported for total scores and sub-scores as appropriate. In addition, repeated measures analysis will be performed for trend analysis.
- The survival of the devices and the rate of revisions will be presented descriptively. The results will also be presented using Kaplan-Meier survival curves. Details of revision procedures will be summarised, including reason, time to revision, components revised.
- Knee related adverse events will be listed and summarized based on the different mechanisms of classification, such as type of event, timing (operative/post-operative), and seriousness.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/10/2021
Date of last participant enrolment
Anticipated
15/04/2023
Actual
Date of last data collection
Anticipated
15/04/2033
Actual
Sample size
Target
300
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 20735 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 20736 0
Melbourne Private Hospital - Parkville
Recruitment hospital [3] 20737 0
GenesisCare - Mater Hospital - North Sydney
Recruitment hospital [4] 20739 0
Epworth Richmond - Richmond
Recruitment hospital [5] 20744 0
Lingard Private Hospital - Merewether
Recruitment hospital [6] 21688 0
La Trobe Private Hospital - Bundoora
Recruitment hospital [7] 21689 0
St Vincent's Private Hospital - Kew
Recruitment postcode(s) [1] 35542 0
3050 - Parkville
Recruitment postcode(s) [2] 35543 0
3052 - Parkville
Recruitment postcode(s) [3] 35544 0
2060 - North Sydney
Recruitment postcode(s) [4] 35546 0
3121 - Richmond
Recruitment postcode(s) [5] 35550 0
3065 - Fitzroy
Recruitment postcode(s) [6] 35551 0
2291 - Merewether
Recruitment postcode(s) [7] 36734 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 309919 0
Commercial sector/Industry
Name [1] 309919 0
Corin Australia Pty Limited
Country [1] 309919 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Corin Australia Pty Limited
Address
17 Bridge Street
Pymble
NSW 2073
Australia
Country
Australia
Secondary sponsor category [1] 310950 0
None
Name [1] 310950 0
Address [1] 310950 0
Country [1] 310950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309639 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 309639 0
Ethics committee country [1] 309639 0
Australia
Date submitted for ethics approval [1] 309639 0
05/05/2021
Approval date [1] 309639 0
20/09/2021
Ethics approval number [1] 309639 0
HREC/76549/MH-2021
Ethics committee name [2] 309644 0
Bellberry Human Research Ethics Committee (HREC)
Ethics committee address [2] 309644 0
Ethics committee country [2] 309644 0
Australia
Date submitted for ethics approval [2] 309644 0
05/05/2021
Approval date [2] 309644 0
10/09/2021
Ethics approval number [2] 309644 0
2021-05-474-A-1

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

Contacts
Principal investigator
Name 114866 0
A/Prof Justin Roe
Address 114866 0
North Sydney Orthopaedic and Sports Medicine Centre
2/ 3 Gillies St
Wollstonecraft
NSW
Australia 2065
Country 114866 0
Australia
Phone 114866 0
+61 2 9409 0558
Fax 114866 0
Email 114866 0
[email protected]
Contact person for public queries
Name 114867 0
Anandita Roy
Address 114867 0
Corin Australia
17 Bridge Street, Pymble NSW 2073
Country 114867 0
Australia
Phone 114867 0
+61 2 9097 7400
Fax 114867 0
Email 114867 0
[email protected]
Contact person for scientific queries
Name 114868 0
Anandita Roy
Address 114868 0
Corin Australia
17 Bridge Street
Pymble NSW 2073
Country 114868 0
Australia
Phone 114868 0
+61 2 9097 7400
Fax 114868 0
Email 114868 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.