Short-term evaluation of clinical safety and performances of the TRAX Cruciate Retaining (CR) system in primary Total Knee Replacement

Amplitude Australia PTY LTD0 个研究点目标入组 50 人开始时间: 2024年2月28日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•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
•- 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

•Patient who received a knee system other than TRAX system on the surgical
•- 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
•- 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

发起方

Amplitude Australia PTY LTD