MissoBOT-A prospective, single-arm, multi-center, post-marketing surveillance study to evaluate the safetyand efficacy of the MISSO™ ROBOTIC SYSTEM. - MISSO ROBOTIC SYSTEM

Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•1.The subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
•2.In the case of a subject and LAR being illiterate a literate impartial witness is required during consenting.
•3.If the subject is not able to write on behalf of the subject the subjects LAR (Legally acceptable representative) can fill out the informed consent.
•4.The subject is willing and able to comply with postoperative scheduled clinical evaluations.
•5.Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
•6.The inclusion criteria for the use of MISSO as a stereotaxic device for knee arthroplasty include surgeons seeking assistance in preoperative planning using patients medical diagnostic images and requiring orientation and reference information during intraoperative procedures.
•7.Only the participating surgeons who oversee the utilization of surgical tools will execute the preoperative surgical plan while using MISSO as a stereotaxic device for knee arthroplasty.
•8.The subject should have attained at least the adult age 18 years at the time of the surgery.

•1.Without informed consent, the subject is not eligible for the study
•2. If the robotic system of any other brand is used, the subject shouldn’t be included in the study
•3. Individuals with any active infections are excluded.
•4. Individuals exhibiting skeletal immaturity are not considered.
•5. Individuals who can be in situations wherein strong infrared sources or infrared reflectors are present in the vicinity of the trackers are
•6. Implants that are not compatible with the system are excluded.
•7. Pregnant ladies shall be excluded from the study.
•8. Subjects with a short life expectancy of fewer than 1 year
•9. Subject with a known sensitivity to device materials
•10. Subjects with neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the
•11. Subjects with a history of deep vein thrombosis or other thrombotic disorders
•12. Subjects with conditions such as severe Parkinsonism and locomotor ataxia that would affect their locomotor stability and interfere with the assessment of the Range of Motion of the target knee
•13. Subjects with severe osteoporosis (T score greater than -3) shall be excluded.

发起方

Meril Life Sciences Pvt Ltd