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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0 项与 THINK Surgical, Inc. 相关的专利（医药）

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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）

2025-01-07

·PRNewswire

THINK Surgical Announces First Use of Medacta International's GMK Sphere® implant with the TMINI® Miniature Robotic System

FREMONT, Calif., Jan. 7, 2025 /PRNewswire/ -- THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced the successful first use of Medacta International's GMK Sphere® Medially Stabilized Knee utilizing the TMINI® Miniature Robotic System by Matthew Beal, MD an Adult Reconstruction Surgeon at the Ohio State University Wexner Medical Center in Columbus, OH. Continue Reading Medacta International The GMK® Sphere and GMK SpheriKA knees are an innovative implant addition to THINK Surgical's ID-HUB™ proprietary implant Data Bank used by the TMINI Miniature Robotic System. The GMK Sphere and SpheriKA® systems are the only medial Ball-in-Socket design knee systems available for use with the TMINI Robot, and the GMK Sphere knee has been shown to provide high stability throughout the entire range of motion.1, 2, 3 Good clinical results have been achieved when implanting GMK Sphere with both mechanical and kinematic alignment philosophies.4, 5 GMK SpheriKA is the latest addition to Medacta's knee portfolio and is the first femoral component specifically optimized for the kinematic alignment technique. Both knee systems also offer a metal-sensitive option with SensiTiN™ coating and cementless applications with MectaGrip coating. "This first case with the TMINI Robot and GMK Sphere by Dr. Beal is an exciting milestone," said Stuart Simpson, CEO and President of THINK Surgical. "Surgical case plans utilizing Medacta's medial stabilized knee designs and commitment to the kinematic alignment philosophy can be executed with precision using our TMINI Robotic system." "We're very excited to announce the first implementation of our partnership with THINK Surgical," said Matt Goudy, Managing Director of Medacta, USA. "This partnership enables surgeons to leverage handheld robotic technology with the GMK Sphere or GMK SpheriKA knee systems, providing the potential to enhance patient outcomes. As the only medial ball-in-socket knee system available for use with the TMINI Robot, we look forward to the results this synergy is expected to bring." THINK Surgical received FDA 510(k) clearance for use of the Medacta GMK Sphere and SpheriKA knee implants with the TMINI Miniature Robotic System on August 29, 2024. 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, ID-HUB and TMINI PRO are trademarks of THINK Surgical, Inc. About Medacta International Medacta is a key global player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta's innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 60 countries. GMK Sphere, SpheriKA and SensiTiN are trademarks of Medacta International. Media Contacts: THINK Surgical Inc. Nick Margree [email protected] Medacta USA Matt Goudy [email protected] SOURCE THINK Surgical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-11-20

·PRNewswire

THINK Surgical Receives FDA 510(k) Clearance for MOBIO™ Knee System implants on TMINI® Miniature Robotic System

FREMONT, Calif., Nov. 20, 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 MOBIO™ Total Knee System from b-ONE Ortho Corporation (Cedar Knolls, NJ) under a Collaboration Agreement between the two companies. Continue Reading b_ONE Ortho Corporation The MOBIO™ Total Knee System has been added to THINK Surgical's ID-HUB™, a proprietary data bank of implant modules for use with the open platform version of its TMINI System in the United States. "THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with eight different knee designs from eight separate orthopedic companies offering surgeons the choice of single-radius, anatomic, and guided motion knees on a single robotic platform." said Stuart Simpson, president, and chief executive officer of THINK Surgical. "We are very enthusiastic about receiving this clearance for use with the THINK Surgical TMINI System platform, which not only enhances our MOBIO™ Total Knee System portfolio in offering our customers a robotic assisted technology solution, but it also provides b-ONE greater market penetrating strategic options and solutions. We look forward to this continued partnership with THINK Surgical offering a proven total knee design that can provide a smooth transition for many surgeons across the United States", said Jim Duncan, General Manager of b-ONE Ortho Corporation. About THINK Surgical, Inc. THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots. THINK Surgical actively collaborates with healthcare professionals 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 and TMINI are trademarks of THINK Surgical, Inc. About b-ONE Ortho Corporation b-ONE Ortho is a Global Manufacturer based out of Cedar Knolls, New Jersey. We, at b-ONE, are committed to improving the experience of both patients and surgeons through innovative technologies. With our passion for advanced manufacturing, advanced material science, artificial intelligence, and robotics, we relentlessly pursue ways to offer best in class healthcare solutions while increasing healthcare economic value. Our goal is to help more patients worldwide to gain their active lifestyle back with the best means humankind ever created-innovative technology. Media Contacts: SOURCE THINK Surgical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-11-19

·PRNewswire

THINK Surgical Receives FDA 510(k) Clearance to use Freedom® Total Knee, Freedom Titan® Knee, and Freedom Primary PCK® System implants with TMINI® Miniature Robotic System

FREMONT, Calif., Nov. 19, 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 Freedom Total Knee, Freedom Titan Knee, and Freedom Primary PCK Systems from Maxx Orthopedics, Inc. (Norristown, PA) under a Collaboration Agreement between the two companies. Continue Reading Maxx Orthopedics The Freedom Total Knee, Freedom Titan Knee, and Freedom Primary PCK Systems have been added to THINK Surgical's ID-HUB™, a proprietary data bank of implant modules for use with the open platform version of its TMINI System in the United States. The Freedom Total Knee and Freedom Titan Knee Systems feature a multi-radius design that accommodates individual patient anatomy, potentially leading to improved alignment and positioning for long-term success. It offers an enhanced range of motion that can achieve flexion up to 155 degrees to help improve functional outcomes for active lifestyles after surgery. Clinically, it has demonstrated strong performance and durability with a 10-year survivorship of 98.3%1. "Maxx Orthopedics believes in great partnerships and is excited surgeons will have the ability to perform robotic-assisted TKA procedures with our Freedom Total Knee System. Combining our knee solutions with the TMINI System, surgeons can choose from multiple implant options- standard materials to metal sensitivity solutions- and seamlessly perform conventional or robotic-assisted procedures," said Ashesh Shah, chief executive officer of Maxx Orthopedics. "THINK Surgical is excited to offer the TMINI System for use with the Freedom Knee System. The open platform version of TMINI is now available with eight different knee designs from eight separate orthopedic companies offering surgeons the choice of single-radius, anatomic (multi-radius), and guided motion knees on a single robotic platform" said Stuart Simpson, president, and chief executive officer of THINK Surgical. References 1. Durbhakula S, Rego L, Eberle R: Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Continuation of Earlier Studies at 10-Years follow-up. J Orthop Exp Innovation, [Accepted for Publication], 2024. About THINK Surgical, Inc. THINK Surgical, Inc., is a privately held U.S.-based technology innovator that develops and markets orthopedic robots. THINK Surgical actively collaborates with healthcare professionals 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 and TMINI are trademarks of THINK Surgical, Inc. About Maxx Orthopedics Maxx Orthopedics is the manufacturer of the Freedom Total Knee System, Freedom Titan Knee System, Freedom PCK System, Libertas® Total Hip System, and Quick Recovery Solutions (QRS®). The company develops and markets innovative orthopedic medical devices worldwide with a focus on providing state-of-the-art implants and related solutions that best restore patient mobility while accommodating lifestyle, anatomical and economic needs. Discover more at and follow us on LinkedIn, X, Instagram, and Facebook. Media Contacts: THINK Surgical Maxx Orthopedics, Inc. Nick Margree Donald Montgomery [email protected] [email protected] SOURCE THINK Surgical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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