ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total knee arthroplasty

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Musculoskeletal

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]

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]

Safety

Assessment method [1]

Possible adverse events following knee arthroplasty could be linked to the surgery and/or implanted devices. The most recurrent potential residual risks / side effects and potential complications usually encountered during total knee replacement linked to the surgery or known in the state of the art include:
- Impact of the surgery on the patient’s general condition
- Wounding of important arteries in the lower limb (e.g. popliteal artery) or a nerve (the sciatic nerve in particular)
- Disruption or rupture of the extensor system (e.g. patellar or quadricipital tendons)
- Rupture of an extensor muscle, following a patellar fracture or ruptured tendon for instance
- Infection
- Prolonged stiffness
- Knee instability
- Pain
- Patella clunk syndrome
- Allergy to the implant materials
- Osteolysis
- Adverse reactions of human tissues to wear debris and particles
- Periprosthetic bone fracture
- Dislocation of the component or the entire prosthesis
- Loosening of the component or the entire prosthesis
- Wearing of the bearing surfaces
- Breakage of the component or the entire prosthesis
- Migration of a component or the entire prosthesis
- Impingement between the implant and the surrounding tissues

Other events linked to the surgery or known in the state of the art can also occur:
- Cardio-vascular, thromboembolic disorders: superficial or deep vein thrombosis and fat or pulmonary embolism
- Hematoma
- Algoneurodystrophy
- Heterotopic ossification
- Pejorative bone remodeling
The adverse events will be collected at minima perioperatively, at the 6-month appointment, and at the 2-year appointment. Any adverse event that occurred in between and reported from the patient to the surgeon will be also collected.
Information regarding the occurred adverse event will be reported by the surgeon or by the Australian registry delegates through the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) Real-time Automated Platform for Integrated Data capture (RAPID) Platform by following by filling in a study-specific adverse event form.

Timepoint [1]

Perioperative, 6 months and 2-years post-operative

Primary outcome [2]

Survivorship

Timepoint [2]

Perioperative, 6 months and 2 years post-operative

Secondary outcome [1]

Performance

Timepoint [1]

Preoperative, 6 months and 2 years post-operative

Secondary outcome [2]

Performance

Timepoint [2]

Preoperative, 6 months and 2 years post-operative

Secondary outcome [3]

Performance

Timepoint [3]

6 months and 2 years post-operative

Secondary outcome [4]

Performance

Timepoint [4]

6 months and 2 years post-operative

Secondary outcome [5]

Performance

Timepoint [5]

Preoperative
6 months and 2 years post-operative (only if standard of care)

Secondary outcome [6]

Performance

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Amplitude SAS

Address [1]

11 Cours Jacques Offenbach, 26000 Valence

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

https://svhm.org.au/home/research/researchers/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/02/2024

Approval date [1]

09/08/2024

Ethics approval number [1]

107534 - 2024/PID00101 - HREC 086/24

Ethics committee name [2]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [2]

https://www.slhd.nsw.gov.au/rpa/research/

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/02/2024

Approval date [2]

31/05/2024

Ethics approval number [2]

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

Dr Darren B. Chen

Address

St George Private Hospital, 19 Kensington Street, Kogarah, NSW 2217

Country

Australia

Phone

+612 8307 0333

Fax

darrenchen@sydneyknee.com.au

Contact person for public queries

Name

Mathieu MOUI

Address

Amplitude Australia, 6/3 Julius Avenue, North Ryde, NSW 2113

Country

Australia

Phone

+61 437 525 176

Fax

mathieu.moui@amplitude-ortho.com

Contact person for scientific queries

Name

Darren B. Chen

Address

St George Private Hospital, 19 Kensington Street, Kogarah, NSW 2217

Country

Australia

Phone

+612 8307 0333

Fax

darrenchen@sydneyknee.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically