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Trial registered on ANZCTR


Registration number
ACTRN12624000192583
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
28/02/2024
Date last updated
18/08/2024
Date data sharing statement initially provided
28/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term evaluation of the TRAX in knee replacement
Scientific title
Short-term evaluation of clinical safety and performances of the TRAX Cruciate Retaining (CR) system in primary Total Knee Replacement
Secondary ID [1] 311127 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty 332284 0
Condition category
Condition code
Musculoskeletal 329256 329256 0 0
Osteoarthritis
Musculoskeletal 329447 329447 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TRAX CR TKR is not currently approved for clinical use in Australia and this study is being undertaken via the Clinical Trial Notification Scheme with the Therapeutic Goods Administration (TGA).
The TRAX CR TKS was developed by Amplitude (Valence, France) with the support of a design group of five Australian surgeons, in order for the manufacturer to have a full range of options for the patients. It is a modular cemented Cruciate-Retaining (CR) fixed-bearing implant intended for the total replacement of the knee joint in order to reduce pain and restore knee function in comparison with preoperative status. No major differences exist between the TRAX CR system and the modern cemented total knee systems used in primary TKA in Australia.
Surgeons implementing the TRAX CR system will require specific training in order to implement the system. This training will be provided by Amplitude (the manufacturer) before the study starts.
The TRAX CR system would only be available to participants who are eligible and choose to enrol in this study.
Patients will undergo primary total knee arthroplasty and will be followed up to 2-years post operative. Notably, 1 appointment will be required before surgery, and 2 after surgery (at 6 months and 2 years postoperatively). Each appointment will last between 30 and 45 minutes, will be conducted by the orthopedic surgeon at the private or public hospital where the investigators are appointed.
Please see below a description of each evaluation:
--Preoperative visit:
During the preoperative visit, patients who are possible candidates for this study are screened to determine if they meet the inclusion/exclusion criteria. If the patient is a candidate, the investigator proposes participation in the study to the patient, according to GCP guidelines.
Patients must sign an HREC-approved Patient Informed Consent Form prior to participating in any study-related activities. Consent must be obtained prior to surgery.
Once the patient has consented, preoperative data will be collected including:
demographics and medical history, Hip-Knee-Ankle (HKA) angle, Range of Motion (ROM),, Oxford Knee Society (OKS) score , EQ-5D-5L and radiographs.

--Surgery: Surgical details will be collected from the operative notes and at the time of surgery.
The surgery duration is expected to be consistent with total knee replacement procedures, usually taking 1 to 2 hours.

--6-month visit: During the 6-month visit (+2 months/-1 month), the following evaluations will be collected: HKA, ROM, OKS, Forgotten Joint Score (FJS), EQ-5D-5L ,radiographs (only if standard of care) and any occurred adverse event since surgery.

--2-year visit : During the 2-year visit (± 3 months), the following evaluations will be collected: HKA, ROM, OKS, FJS, EQ-5D-5L ,radiographs and any occurred adverse event since last visit.
Intervention code [1] 327758 0
Diagnosis / Prognosis
Comparator / control treatment
Modern cemented CR TKR systems currently used in Australia will be used as comparators in this field.
There are no key differences between those systems and the TRAX CR TKR system.
Control group
Active

Outcomes
Primary outcome [1] 337080 0
Safety
Timepoint [1] 337080 0
Perioperative, 6 months and 2-years post-operative
Primary outcome [2] 337081 0
Survivorship
Timepoint [2] 337081 0
Perioperative, 6 months and 2 years post-operative
Secondary outcome [1] 430598 0
Performance
Timepoint [1] 430598 0
Preoperative, 6 months and 2 years post-operative
Secondary outcome [2] 431259 0
Performance
Timepoint [2] 431259 0
Preoperative, 6 months and 2 years post-operative
Secondary outcome [3] 431260 0
Performance
Timepoint [3] 431260 0
6 months and 2 years post-operative
Secondary outcome [4] 431261 0
Performance
Timepoint [4] 431261 0
6 months and 2 years post-operative
Secondary outcome [5] 431262 0
Performance
Timepoint [5] 431262 0
Preoperative
6 months and 2 years post-operative (only if standard of care)
Secondary outcome [6] 431263 0
Performance
Timepoint [6] 431263 0
Preoperative, 6 months and 2 years post-operative

Eligibility
Key inclusion criteria
Patients requiring a primary knee replacement, for which the device is indicated
and including a resurfaced patella as determined jointly by the surgeon and the
patient.
- Patients over 18 years of age at time of surgery
- Patients willing and able to comply with postoperative scheduled clinical and
radiographic evaluations
- Patients able to understand and sign the study specific informed consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient who received a knee system other than TRAX system on the surgical
knee
- Patient undergoing revision of a primary TKR.
- Patients with co-morbidities that preclude the use of a CR knee such as
incompetent collateral ligament or severe posterior cruciate ligament instability
or extensor mechanism incompetence.
- Patients with active infection or severe immunocompromise.
- Pregnant females or those planning on becoming pregnant during follow-up
period
- Patients with a known allergy to the medical device component(s)
- Patient involved in other interventional research study
- Patient belonging to a vulnerable group of patients, including minor patients,
those unable to decide for themselves to participate or needing a Legally
Authorized Representative, or others who could be subject to coercion (patients
who may not be acting on their own initiative) (referred as “vulnerable subject”
in the section 3.55 of the ISO 14155:2020 standard)
- Patient deprived of liberty or under guardianship
- Patient not able to comply with the study procedures based on the judgment of
the investigator (e.g. cannot understand study questions, inability to keep
scheduled assessment times)
- Patient doesn’t consent to participate to the study
- Any psychological, familial, geographical, or sociological condition that does not
allow to respect the medical follow-up and / or the scheduled procedures in the
study protocol
- Workers’ compensation patients

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 315384 0
Commercial sector/Industry
Name [1] 315384 0
Amplitude SAS
Country [1] 315384 0
France
Primary sponsor type
Commercial sector/Industry
Name
Amplitude Australia PTY LTD
Address
Suite 402, 44 Miller Street, North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 317446 0
None
Name [1] 317446 0
Address [1] 317446 0
Country [1] 317446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314461 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314461 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314461 0
Australia
Date submitted for ethics approval [1] 314461 0
19/02/2024
Approval date [1] 314461 0
09/08/2024
Ethics approval number [1] 314461 0
107534 - 2024/PID00101 - HREC 086/24
Ethics committee name [2] 314462 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 314462 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [2] 314462 0
Australia
Date submitted for ethics approval [2] 314462 0
01/02/2024
Approval date [2] 314462 0
31/05/2024
Ethics approval number [2] 314462 0
X24-0051 & 2024/ETH00183

Summary
Brief summary
This study aims to evaluate the clinical safety and performance of the TRAX Cruciate Retaining (CR) Total Knee System (TKS) used in primary Total Knee Arthroplasty (TKA)
The study is prospective, multi-centre, non-randomised, comparative and single arm.
The clinical safety will be evaluated through the analysis of adverse events and serious adverse events and thorough the 2-year survivorship of the system.
Performance wil be evaluated through functional measurements and questionnaires.
The clinical and safety performance of the TRAX CR TKS will be compared to the
ones of modern cemented CR TKS used in primary TKA in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131118 0
Dr Darren B. Chen
Address 131118 0
St George Private Hospital, 19 Kensington Street, Kogarah, NSW 2217
Country 131118 0
Australia
Phone 131118 0
+612 8307 0333
Fax 131118 0
Email 131118 0
[email protected]
Contact person for public queries
Name 131119 0
Mathieu MOUI
Address 131119 0
Amplitude Australia, 6/3 Julius Avenue, North Ryde, NSW 2113
Country 131119 0
Australia
Phone 131119 0
+61 437 525 176
Fax 131119 0
Email 131119 0
[email protected]
Contact person for scientific queries
Name 131120 0
Darren B. Chen
Address 131120 0
St George Private Hospital, 19 Kensington Street, Kogarah, NSW 2217
Country 131120 0
Australia
Phone 131120 0
+612 8307 0333
Fax 131120 0
Email 131120 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.