Short-term evaluation of the TRAX in knee replacement

Not Applicable

• Conditions: Total knee arthroplasty; Musculoskeletal - Osteoarthritis; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12624000192583
• Lead Sponsor: Amplitude Australia PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-28
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

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

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

• Study Type: Interventional
• Study Design: Not specified