The goal of this prospective, non-randomized, multicenter clinical trial is to determine whether robotic-assisted total knee arthroplasty performed with TSolution One® System is safe and effective for use as an alternative to the conventional manual techniques. Clinical and radiographic outcomes for robotic-assisted total knee arthroplasty performed with the TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively up to a follow-up period of no less than 6 months and no more than 12 months. These outcomes will be compared to the ones reported in the literature for conventional manual techniques.

开始日期2017-02-18

申办/合作机构

THINK Surgical, Inc.

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项与 THINK Surgical, Inc. 相关的文献（医药）

2021-07-01·Journal of orthopaedics

Safe and effective use of active robotics for TKA: Early results of a multicenter study

Article

作者: Stulberg, Bernard N ; Kissin, Yair D ; Campanelli, Valentina ; Zadzilka, Jayson D ; Long, William J ; Kreuzer, Stefan ; Liebelt, Ralph

BACKGROUND:

A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population.

METHODS:

A multicenter clinical trial was conducted, following 115 patients for at least 6-months. A pre-defined list of robot-related adverse events was used to evaluate safety. Efficacy was assessed radiographically comparing planned versus achieved coronal limb alignment.

RESULTS:

No pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases.

CONCLUSION:

Active robotics for TKA is safe and effective as demonstrated in this trial.

2020-11-28·Surgical technology international

Active Robotic Total Knee Arthroplasty (TKA): Initial Experience with the TSolution One ® TKA System.

Article

作者: Liebelt, Ralph ; Kissin, Yair D ; Auld, Thomas S ; Long, William J ; Campanelli, Valentina ; Kreuzer, Stefan ; Chan, Jason

Several recent advances, including the use of robotic devices, have been explored to improve outcomes in total knee arthroplasty (TKA). The TSolution One ® Total Knee Application (THINK Surgical, Inc., Fremont, CA, USA) introduces an active robotic device that supports an open implant platform and CT-based preoperative planning workflow, and requires minimal surgeon intervention for making bone cuts. Our experience was part of a multi-center, prospective, non-randomized trial assessing the safety and effectiveness of this active robotic system for TKA. Each patient underwent a preoperative CT-scan, which was uploaded to proprietary planning software. The surgeon reviewed the software-generated 3D digital model, selected the appropriate implants and generated a final preoperative plan. Intra-operatively, a standard medial parapatellar approach was used. The leg was then rigidly attached to the robot via fixation pins, and registration markers were placed in the tibia and femur. Landmark registration was performed to inform the robot of the knee's position in space and to confirm the robot's ability to execute the preoperative plan. Next, the robot performed femoral and tibial cuts using a cutter in a sequential fashion along a defined cut-path. The robot was then removed from the operative field and the surgeon completed the procedure by removing marginal bone and performing final balancing and implantation in the usual fashion. The TSolution One® Total Knee Application is a computer-assisted device that potentially allows a surgeon to make more accurate cuts and to determine optimal implant position based on the patient's specific anatomy. It is the only active robotic system currently available. In this manuscript, we describe the operative technique and workflow involved in performing this surgery and offer insight on optimizing safety and efficiency as we introduce new technologies to the operating theater. We also present two cases performed by the senior author to further demonstrate technical aspects of the procedure.

2020-02-01·Quantitative imaging in medicine and surgery3区 · 医学

Implant placement accuracy in total knee arthroplasty: validation of a CT-based measurement technique

3区 · 医学

Article

作者: Maislin, David ; Akhlaghpour, Hosna ; Zuhars, Joel ; Lozano, Rocio ; Brar, Abheetinder S ; Campanelli, Valentina ; Nedopil, Alexander J

BACKGROUND:

The primary goal of many computer-assisted surgical systems like robotics for total knee arthroplasty (TKA) is to accurately execute a preoperative plan. To assess whether the preoperative plan was executed accurately in 3D, one option is to compare the planned and postoperative implant placement using a preoperative and postoperative CT scan of the patient's limb. This comparison requires a 3D-to-3D surface registration between the preoperative and postoperative 3D bone models and between the planned and postoperative 3D implants. Hence, the present study aimed at validating this measurement technique by determining (I) the anatomical regions that result in the lowest 6-degree of freedom (DoF) errors for 3D-to-3D surface registration of bone models, (II) the 6-DoF errors for 3D-to-3D surface registration of the implant models, and (III) the 6-DoF of the complete measurement technique.

METHODS:

Four different regions of the femur were tested to determine which one would result in the most accurate 3D-to-3D registration of the bone models using 12 cadaveric lower limb specimens. Next, total knee arthroplasties were performed on six specimens, and the accuracy of the 3D-to-3D implant registration was evaluated against a gold standard registration performed using fiducial markers.

RESULTS:

The most accurate 3D-to-3D bone registration was obtained when using the largest anatomical regions available after TKA, being the full 3D femur model or the femur model without the distal femur which resulted in root mean square errors within 0.2 mm for translations and 0.2° for rotation. The accuracy of the 3D-to-3D femoral and tibial implant registration was within 0.7 mm for translations and 0.4°-0.6° for rotations, respectively. The accuracy for the overall procedure was within 0.9 mm and 0.6° for both femur and tibia when using femoral regions resulting in accurate 3D-to-3D bone registration.

CONCLUSIONS:

In conclusion, this measurement technique can be used in applications where measurement errors up to 0.9 mm in translations and up to 0.6° in rotations in component placement are acceptable.

项与 THINK Surgical, Inc. 相关的新闻（医药）

2024-09-10

·PRNewswire

THINK Surgical Announces First Use of Its TMINI Miniature Robotic System with New Features

FREMONT, Calif., Sept. 10, 2024 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced the successful completion of the first total knee arthroplasty procedure utilizing its new TMINI® Miniature Robotic System version 1.1 following recent FDA 510(k) clearance. Continue Reading TMINI Miniature Robotic System The TMINI System version 1.1 features the TMINI PRO™ workflow which empowers surgeon choice throughout the procedure by enabling Positional Refinement and Optimization (PRO) of the implant tailored to the patient's needs. The robotic total knee surgery was performed by Dr. Alexander Sah, Co-Director of the Institute of Joint Restoration, an orthopedic surgeon at the Washington Outpatient Surgery Center located in Fremont, CA. "This first surgery with the TMINI System 1.1 shows that we are continuing to provide cutting edge solutions at our ASC." said Dr. Sah. "The added ability to objectively assess soft-tissue balance and make adjustments intraoperatively, combined with the small form factor, makes it the ideal option for robotics in the outpatient setting." "We are thrilled to work with an institution and surgeon as motivated as the Washington Outpatient Surgery Center and Dr. Sah," said Stuart Simpson, President, and Chief Executive Officer of THINK Surgical. "This milestone is another testament to the differentiated design, business model, and market fit of the TMINI System for all institutions, especially for ASC accessibility, and adds further validation to our commercial strategy of becoming the market leader in outpatient robotic total knees." About THINK Surgical, Inc. THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots. THINK Surgical robots are open platforms providing support for implant brands from multiple manufacturers, enabling the choice of implant to be driven by the surgeon. THINK Surgical actively collaborates with healthcare professionals around the globe to refine our orthopedic products, improving the lives of those suffering from advanced joint disease with precise, accurate, and intelligent technology.  Please refer to the instructions for use for the TMINI Miniature Robotic System for a complete list of indications, contraindications, warnings, and precautions. For additional product information, please visit . THINK Surgical, TMINI and TMINI PRO are trademarks of THINK Surgical, Inc. Dr. Alexander Sah works with THINK Surgical, Inc. as a consultant and as its medical director. Media Contact: THINK Surgical Inc. Nick Margree [email protected] SOURCE THINK Surgical, Inc.

2024-09-09

·FierceBiotech

Think Surgical collects clearances for its handheld knee replacement robot

The FDA recently issued Think Surgical two clearances, one for each track of its development program, which includes an open implant platform and an exclusive system customized for Zimmer Biomet. The orthopedic robotics developer Think Surgical has collected its third FDA clearance in as many months, with a specialized version of its knee replacement system designed to be paired with an implant from Zimmer Biomet.The company’s TMINI platform first received an agency green light in May 2023, featuring a wireless, handheld tool that relies on a three-dimensional model built from a CT scan to help guide surgeons in the accurate placement of bone pins and cutting guides.Think Surgical obtained an updated 510(k) for version 1.1 of the system in July, which it said added the ability to refine the position and soft-tissue balance of the replacement joint.The company has been developing its robotic approach on two different tracks: one with an open platform capable of being used with a range of hardware, and one that can be used exclusively with a single implant brand or manufacturer.August and September have brought FDA clearances on both sides of that coin. For the open platform, Think Surgical collaborated with Medacta International to add support for its GMK Sphere and SpheriKA knee systems.Shortly afterward, the company announced last week that its exclusive, customized system will work with Zimmer Biomet’s Persona knee. “TMINI addresses surgeon demand for ergonomic, wireless, handheld robotic systems and we believe this will accelerate adoption of robotics in knee procedures, particularly in the out-patient setting,” Think Surgical CEO Stuart Simpson said in a statement.Think Surgical and Zimmer Biomet previously inked a limited distribution deal, tied to the exclusive version of TMINI, which was announced this past June.“We believe that there are two distinct customer segments, one which prefers an open platform where the customer can choose from a range of implants on the robot and another which prefers an exclusive platform where the customer gains access to the robot in return for loyalty to a single implant brand,” Simpson said at the time. “We believe that these two customer segments are approximately equal.”The company estimates that, among its collaborations, its device can support about 40% of the total knee implants on the market.

2024-09-05

·PRNewswire

THINK Surgical Receives FDA 510(k) Clearance for Zimmer Biomet Persona Knee on TMINI® Miniature Robotic System

FREMONT, Calif., Sept. 5, 2024 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the Persona® The Personalized Knee System® from Zimmer Biomet. Continue Reading TMINI Miniature Robotic System The availability of the Persona Knee System on an exclusive version of the TMINI System is a major milestone for THINK Surgical. THINK Surgical is the only company offering a robotic system providing both an implant exclusive option with the Persona Knee System and an open implant platform for use with implants from multiple other manufacturers for total knee arthroplasty. This go-to-market strategy supports two distinct customer segments, one which prefers an open platform where the customer can choose from a range of implants on the robot and another which prefers an exclusive platform with the market leading Persona Knee System. "TMINI addresses surgeon demand for ergonomic, wireless, handheld robotic systems and we believe this will accelerate adoption of robotics in knee procedures, particularly in the out-patient setting." said THINK Surgical CEO, Stuart Simpson. About THINK Surgical, Inc. THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots. THINK Surgical robots are open platforms providing support for implant brands from multiple manufacturers, enabling the choice of implant to be driven by the surgeon. THINK Surgical actively collaborates with healthcare professionals around the globe to refine our orthopedic products, improving the lives of those suffering from advanced joint disease with precise, accurate, and intelligent technology.  Please refer to the instructions for use for the TMINI Miniature Robotic System for a complete list of indications, contraindications, warnings, and precautions. For additional product information, please visit . THINK Surgical, TMINI and TMINI Pro are trademarks of THINK Surgical, Inc. Media Contact: THINK Surgical Inc. Nick Margree [email protected] SOURCE THINK Surgical, Inc.