MCRA was chosen by THINK Surgical as its orthopedic specialty clinical research organization (CRO) to conduct its clinical trial in support of FDA 510(k) clearance to market the TSolution One® Total Knee Application for use in total knee arthroplasty (TKA).
TSolution One TKA includes CT-based 3D pre-surgical planning software, which allows surgeons to virtually design and prepare the patient's joint replacement plan using the surgeon's implant of choice. The surgeon implements the procedure using the active robot, which prepares the joint according to the plan. The system was previously CE Marked and has been actively marketed in Asia Pacific and European regions.
Five surgeons participated in the clinical trial, which confirmed the safety and effectiveness of the system compared to traditional knee replacement with manual surgical instrumentation. Study enrollment began in 2017 and completed in December 2018. Data collection was completed in 2019, with 100% retention of the 115 enrolled patients.
MCRA, an advisory firm and CRO focused on the neuro-musculoskeletal industry, provided clinical study management support for the pivotal study and assisted with preparing and submitting the Investigational Device Exemption (IDE) to FDA.
Specifically, MCRA assisted THINK Surgical by:
- Managing operational and data management aspects of the study, such as negotiating site contracts and budgets, training the clinical research sites and monitoring study data
- Helping the sites adopt measures to achieve a 100% patient retention rate, improving the reliability of the study's statistical outcomes
- Conducting site audits and preparing the sponsor and sites for the five Bioresearch Monitoring Program inspections that took place once the study was concluded
- Obtaining CMS approval for coverage of Medicare-eligible patients who participated in the IDE trial