1129-18-VS (SP-DT)A clinical study to check whether the proposed patient specific instrument (X-ray based PSI) developed using X-ray based 3D planning software performs equivalent to conventional instrument, to achieve accurate post-operative lower-limb mechanical axis alignment; for total knee replacement (TKR) surgery

Algosurg Products Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female aged greater than 45 years
•2. Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
•3. Able to understand what participation in the study entails and willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an IRB/EC approved informed consent form
•4. Able and willing to undergo a preoperative and intraoperative imaging (X-ray, CT)
•5. Should not have any other deformity in the leg to be operated
•6. Approve the fitting / placement of X-ray based PSI on the exposed surface of the bone intraoperatively

•1. Is currently enrolled in an investigational new drug or device study
•2. Has had a prior ipsilateral uni-compartmental knee arthroplasty, TKA, knee fusion or patellectomy
•3. Have indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of Tibial plateau fracture, etc.
•4. Has arterial disease or stents that would exclude the use of a tourniquet
•5. Has a mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfil the requirements of the study

发起方

Algosurg Products Pvt Ltd