active robotic total knee arthroplasty (tka): initial

SSeveral 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

Active Robotic Total Knee Arthroplasty(TKA): Initial Experience with the

TSolution One ® TKA System JASON CHAN, MD

PGY-3 RESIDENT, ORTHOPAEDIC SURGERYRUTGERS NEW JERSEY MEDICAL SCHOOL, NEWARK, NJ

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ABSTRACT

Orthopaedic SurgerySURGICAL TECHNOLOGY INTERNATIONAL Volume 37

THOMAS S. AULD, MDPGY-4 RESIDENT, ORTHOPAEDIC SURGERY

RUTGERS NEW JERSEY MEDICAL SCHOOL, NEWARK, NJ

BERNARD STULBERG, MDHEAD, ROBOTIC JOINT CENTER

ST. VINCENT CHARITY MEDICAL CENTERCLEVELAND, OH

WILLIAM J. LONG, MD, FRCSCDIRECTOR, INSALL SCOTT KELLY® INSTITUTE

NEW YORK, NYCLINICAL ASSOCIATE PROFESSOR, NYU, NEW YORK, NY

STEFAN KREUZER, MD, MSCJOINT REPLACEMENT SURGEON

INOV8 ORTHOPEDICSHOUSTON, TX

VALENTINA CAMPANELLI, PHDCLINICAL RESEARCH MANAGER

THINK SURGICAL, INC.FREMONT, CA

RALPH LIEBELT, MDJOINT REPLACEMENT SURGEON

EMERGEORTHODURHAM, NC

YAIR D. KISSIN, MDVICE CHAIR, DEPARTMENT OF ORTHOPAEDIC SURGERY,

HACKENSACK UNIVERSITY MEDICAL CENTERHACKENSACK, NJ

ASSISTANT CLINICAL PROFESSORHACKENSACK MERIDIAN SCHOOL OF MEDICINE AT SETON

HALL UNIVERSITY, NUTLEY, NJRUTGERS NEW JERSEY MEDICAL SCHOOL, NEWARK, NJ

Copyright © 2020 Surgical Technology International™

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Total knee arthroplasty (TKA) is gen-erally a highly successful procedure.However, malalignment and implantmalposition continue to be significantcauses of revision surgery.1 The use ofrobotic devices may help to improve out-comes in TKA.Robotic technology in various forms

is currently used in many operatingrooms, not only in orthopaedic surgery.For example, it is ubiquitous in manyurologic, gynecologic, and abdominalsurgeries, especially in academic medicalcenters.2 Several robots have been devel-oped for both unicondylar and TKA,with the goals of optimizing precisionand accuracy in bony cuts.3,4 Whereassome image-based robots take advantageof preoperative CT scans to plan bonycuts, others may use intraoperative map-ping without the need for advanced pre-operative images. Several approaches canbe used in active, haptic, and passive sys-tems to aid the surgeon in achieving

accurate bone cuts and a balanced knee.5With active devices, the robot performsthe bony cuts without direct contactbetween the surgeon and the cuttingtool. Haptic systems allow for the sur-geon to perform bony preparation usinga cutting tool attached to a robotic armwhich gives feedback regarding the cor-rect position and trajectory of the cuts.Finally, in passive systems, the roboticarm places the cutting blocks and cutsare made directly by the surgeon using astandard saw-through-slot technique.5The TSolution One® system (THINK

Surgical, Fremont, CA, USA) is anactive robotic milling system that uses apreoperative CT scan for planning andexecution of automated bony cuts.6 Ahigh-speed burr is used for bony resec-tion, which may eliminate errors thatcan occur with systems that use a sawblade, which is inherently flexible.7,8 It isalso an open-implant platform whichallows the surgeon to choose from avariety of implant manufacturers. Earlyresults with the active robot in a recent

FDA IDE trial regarding the accuracy ofimplant positioning, alignment, and safe-ty are encouraging. Here, we presentour center’s experience with 25 casesusing the TSolution One ® system,focusing on preoperative planning andthe operative technique. We present tipsand tricks from our experience and pre-sent two cases that illustrate ourapproach.

Technique

While robotic surgery is not yet near-ly the standard of care in joint replace-ment, it has attracted the attention ofmany surgeons as possibly the next majoradvancement in the field.9,10 As in mostsimilar technologies in total jointreplacement, the steps include preopera-tive imaging, which generates a virtualplan, intraoperative registration and exe-cution of the plan with the assistance ofthe robotic device.

PREOPERATIVE PLANNINGInformed consent was obtained from

eligible patients (Table I). Preoperativeimaging consisted of full-length hip-to-ankle standing radiographs and CT scanof the operative limb. A CT scan wasperformed according to a strict protocolthat required training of technologistsand vetting of the facility to ensure accu-rate image capture. CT images were thenanalyzed and segmented by the manufac-turer, who would then generate a stan-dard preoperative plan using aproprietary preoperative planning soft-ware called TPLAN® (Fig. 1).The standard preoperative plan was

then sent to the surgeon for review (Fig.2) using a dedicated computer stationwith TPLAN®. Virtual 3D models of thebone and implant appear on the screen,

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Active Robotic Total Knee Arthroplasty (TKA): Initial Experience with the TSolution One® TKA SystemCHAN/AULD/STULBERG/LONG/KREUZER/CAMPANELLI/LIEBELT/KISSIN

INTRODUCTION

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.

Table IStudy Inclusion and Exclusion Criteria

Inclusion Criteria Exclusion Criteria

Age >21 Previous open knee surgery on operative knee

Skeletally mature- Evidencedby closed physes

BMI> 40kg/m2

Radiographic osteoarthritis Kellgren-Lawrence Grade3 orhigher

Coronal deformity > 20degFlexion contracture > 15degCandidate for bilateral TKAActive systemic infection, active local infectionnear knee, prior joint infection

Presence of hardware in ipsilateral lowerextremity

Poor bone stockPathologic bone condition

TECHNIQUE

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which the surgeon can manipulate tovisualize the bone, implant, anatomicaxes, or all three simultaneously. Thesurgeon would first verify the location ofthe preselected bony landmarks (i.e.,femoral head center, medial and lateralepicondyles, etc.) which are importantfor identification of the mechanical axesand for intraoperative registration, assome of the points selected in planningwill need to be collected from thepatient for initial registration. The next steps are femoral and tibial

planning. First, the surgeon selects thepreferred implant; since this system is anopen platform, more than one implant isavailable. At the time of publication, Zim-mer (Zimmer Biomet, Warsaw, IN, USA),Corin (Corin Group, Tampa, FL, USA),DJO (DJO Global, Lewisville, TX, USA),Aesculap (Aesculap Implant Systems,LLC, Center Valley, PA, USA), and U2™Knee System (United Orthopedic Corpo-ration, New Taipei City, Taiwan) implantsare available for this platform. Next, thesurgeon can alter the resection depth,alignment, and implant placement in one-half degree or one-half millimeter incre-ments based on alignment goals and thepatient’s anatomic axes. For example, thesurgeon may choose between eithermechanical alignment or kinematic align-ment TKA, both of which were success-fully performed in our study group.One learning point that was noted

during the study was that, when choosingbetween two tibial component sizes, in asurgeon’s early experience, it was advis-able to select the smaller size. Since thecutting depth is related to the size of theimplant, while the resection plane wouldremain the same, less bone is removednear the perimeter of the implant. Thisallows the surgeon to gauge the protec-tion of soft tissues, allowing more preciseretractor placement. With experience,this may not be necessary. This concept isalso applicable to the femoral side if stan-dard versus narrow implants are available.This is one of the safety mechanisms inplace to prevent soft tissue injury; in ourseries, this proved successful, as no suchinjuries were noted.Once the surgeon is satisfied with the

plan, it is finalized. The last step is approv-ing the sequence of cuts where the sur-geon decides whether or not to includefemoral and/or tibial finishing steps in thesequence. As the study progressed andconfidence in use of the device increased,this finishing step became more widelyused in our surgeries.

SURGERYSurgery involves standard exposure,

fixation, registration, and robotic boneresection, followed by trialing, balancing,and implantation of the final prosthesis.One important value of an accurate pre-operative plan is that implant sizes are

already determined to a high degree ofaccuracy and therefore fewer trays mayneed to be opened, reducing the amountof clutter in the operative field.The patient is brought to the operat-

ing suite after a surgical technician per-forms preliminary diagnostics on the

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Figure 1. TPLAN® -Software used to create the pre-operative plan (THINK Surgical, Inc.)

Figure 2. Pre-operative plan highlights implant selection, resection depths and alignment, and providesvisualization of implanted components relative to the bone.

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robot. Anesthesia is then applied, whichat our institution includes a single-shotshort-acting spinal along with adductorand IPAK (Interspace between thePopliteal Artery and Knee capsule)blocks in conjunction with multimodalpain management. The patient’s leg isplaced in a sliding knee-positioningdevice and a standard medial parapatellarapproach is then performed. PEARLS ON EXPOSURE: First, dur-

ing exposure, it is important not toremove any osteophytes, since thepatient’s bony anatomy is the basis for thepreoperative plan and may well be part ofintraoperative registration. Further, somesurgeons may elect to cut the patella first,prior to positioning of the knee in flex-ion. With this sequence, there is less ten-

sion on the lateral soft tissue, making theresected patella easier to retract out ofthe way of the burr. Finally, the ACL andselectively the PCL along with as muchmeniscus as possible are excised to helpsublux the tibia and ensure that the burrdoes not get bound up in soft tissue. Next, the tibia and femur are firmly

attached to the robot via ex-fix typepins. These pins can be placed percuta-neously or within the incision, based onthe surgeon’s preference. PEARLS ON PIN PLACEMENT:

While we did not experience any pin-or device-related complications in ourseries, placement of such pins in robot-ics and as previously used in navigationcan certainly result in serious morbidi-ty. including fracture, pin-sitedrainage/infection, pain and woundissues.11-15 This robotic device requiresone registration and one fixation pin tobe placed into both the tibia and femur.Proper spacing of pins, at least one totwo fingerbreadths apart, and engage-

ment but not penetration of the secondcortex provide sufficient fixation whilelimiting the risk of fracture. Also, it iscritical to place pins in such a way thatthey are clear of the cut-path of the burr.This is especially important on the tibialside in tibial finishing; the pin needs tobe inserted distal enough to avoid con-tact during milling of the keel.Once these pins are in place, regis-

tration tacks are inserted in the femurand the tibia. The combination of the legholder and external fixation providesrigid fixation of the knee, which isrequired with an active robot. Alongwith the registration pin, the tacks serveas a two-step re-registration if excessmotion is detected during the roboticportion of the case, which stops the burrfrom progressing. Bone motion moni-tors (BMM) are the final preparationstep and are sharply malleted into thetibia and femur. These sensors are ableto detect bone-motion greater than 1mm as the robotic arm is cutting, andwill halt the cutting device within 2mmof motion, for safety and to avoid error(Fig. 3).REGISTRATION: A sharp stylus is

used to register the patient’s anatomiclandmarks based on on-screen instruc-tions. This vital step aligns the virtualpreoperative plan with the patient’s actu-al anatomy intraoperatively and allowsthe robotic arm to locate the knee pre-cisely in space. As this is a CT-based pre-operative planning model, articularcartilage must be pierced so the stylustip contacts subchondral bone to corre-late with the plan appropriately. Whilethis step is familiar to surgeons who haveperformed navigation in the past, evenfor the inexperienced surgeon, it is askill that can be perfected rather quicklyafter several attempts.

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Figure 3. Fixation and registration: Sawbones(Pacific Research Laboratories, Vashon, WA, USA)demonstration with pins and tacks in place.

Figure 4. Bone islands: Sawbones (Pacific Research Laboratories) demonstration of bone islands left inplace after cuts are made.

Figure 5. Burring with minimal retractors in place. Figure 6. Completed cuts including femoral andtibial finishing

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PREPARATION FOR CUTTING:This device allows for very minimalinstrumentation as resection guides andtraditional cutting jigs are completelyeliminated from the procedure. It is sug-gested to have a right-angle retractor and

possibly a lateral Hohmann retractor toprotect the medial and lateral soft tissueduring burring of the bone. A rongeur isuseful for removing loose bone frag-ments as the procedure progresses sothat the burr does not bind up in them.

The cut-path for the burr takes intoaccount the surrounding soft tissue, suchas the medial collateral ligament, patellartendon and posterior knee, and has beendesigned to avoid injury by leaving abony margin of 1-2 mm in the peripheryof the cut (Fig. 4). The surgeon removesthis residual bone once the cuts are com-plete and predictably shields the soft tis-sue. In our study, no soft tissue injurieswere seen with the device. ROBOTIC CUTTING: Once regis-

tration is complete, the robotic armenters the operative field and the cuts areperformed in a predetermined sequencewith a high-speed burr. The surgeon orsurgical assistant can stop the cuttingprocess if needed by pushing a button ona connected handheld device. Minimalsurgeon intervention is needed duringthis step, other than minor retraction androngeuring of loose bone (Figs. 5,6).POST-CUTTING: At the completion

of the cuts, pins and tacks are removedand the robot is removed from the oper-ative field. The surgeon then removes theperipheral residual bone and performsstandard trialing and balancing. Once thesurgeon is satisfied, final implantation isundertaken.

Case Examples

PATIENT 1: A 64-year-old well-con-trolled diabetic male presented to theclinic with a severely arthritic right knee.He was already known to the practice,having undergone successful left TKAthree years previously, but continued tosuffer from debilitating pain and dysfunc-tion of his right knee. X-rays showedsevere osteoarthritis changes, 9.4 degreevarus deformity with bone loss of themedial femoral condyle and to a lesserdegree the medial tibial plateau (Fig. 7).He was indicated for TKA and consentedto be part of the study after failing torespond to nonoperative treatmentsincluding physical therapy and intraartic-ular injections. His degree of deformity along with

bone loss were concerning, but at thatpoint in the study, our team had gainedenough experience and confidence in thedevice that we chose to undertake thiscase robotically. In planning of this case,it was presumed that the burr would per-form an air-cut of the medial femoralcondyle and that there would be a resid-ual defect. However, since his plannedfemoral size was on the large end of thespectrum, we felt that cement would suf-

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Figure 7. Pre-operative imaging in Patient 1. (A) Antero-posterior radiograph of the right knee demonstrat-ing a 9.4 degree varus deformity. (B) Lateral radiograph of the right knee.

Figure 8. Post-operative and intra-operative images in Patient 1. (A) Antero-posterior radiograph of theright knee post TKA demonstrating correction of varus deformity. (B) Lateral radiograph post TKA. (C)Intra-operative image demonstrating large medial femoral condyle defect. (D) Intra-operative image afterfemoral cuts have been made by the robot (E) Intra-operative imaging demonstrating the fit of the femoralcomponent given the large medial femoral condyle defect.

CASE EXAMPLES

Table IIPatient 1

64-year-old male with varus knee

Initial Alignment 9.4 deg varus

Difference in alignment as planned (CT) 0.4 deg more varus than planned

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ficiently fill the gap and obviate the needfor a metal augment. On the tibial side,an extra degree of “Gentleman’s varus”,as has been described recently in the lit-erature,16 was planned in the hope oflimiting the need for a medial release. The surgery proceeded as planned,

with bone loss on the femur noted andcement augmentation being sufficient(Fig. 8). No medial soft-tissue release wasneeded to balance the knee, which webelieve would have been very likely neces-sary if conventional TKA had been per-formed in this case. This casedemonstrated how difficult challenges canbe addressed to result in a successfulTKA. One additional benefit of roboticsover conventional surgery in this case wasthat traditional cutting guides would nothave had adequate bone to rest on andtherefore could have introduced error,while the robotic arm was able to cut thebone with precision despite the bone loss.This patient’s accuracy data are presentedin Table II. The patient experienced con-tact dermatitis from the adhesive dressing,but this resolved uneventfully and was notbelieved to have been related to therobotic device. PATIENT TWO: A 72-year-old

healthy and previously active female witha severely arthritic left knee was indicat-ed for robotic total knee replacement.She consented to participate in the studyafter failing to respond to nonoperativetreatment involving home exercises andover-the-counter medications. Standingradiographs showed a 17-degree valgusdeformity (Fig. 9). The patient under-went successful robotic TKA with noneed for lateral valgus soft tissue releaseor lateral patellar release (Fig. 10). Heraccuracy data are presented in Table III.The valgus knee often presents uniquechallenges in both alignment and soft tis-sue balance, which in this case were man-aged successfully with the robot device.

Discussion

Patients who undergo traditionalTKA currently have a satisfaction rate of82%-89%.17,18 One of the drawbacks ofthe traditional technique is the errorintroduced at each step; i.e., jig place-ment based on anatomic landmarks, cut-ting guides, etc. While the errorintroduced by a single cut may be negli-gible, areas such as the distal femur mayaccumulate significant error, since multi-ple cuts are required. Errors introducedby a cutting guide and oscillating saw

alone can be up to 1.1 degrees in thecoronal plane and 1.8 degrees in thesagittal plane.7Robot-assisted surgery potentially

decreases the error that may be intro-duced by creating more accurate cutsbased on pre-operative plans. The TSolu-tion One ®TKA application is one of sev-eral robot-assisted TKA systemscurrently available. However, it has sever-al unique features that set it apart from

others. For example, TSolution One ® isthe only open platform currently avail-able. This offers flexibility in that a hospi-tal can use implants from differentmanufacturers and does not obligate asurgeon to change from his or her pre-ferred system. It is also the only fullyactive robot, which may offer improvedprecision over traditional TKA.19,20Rather than being a substitute for the sur-geon, it is simply another tool which

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Figure 9. Pre-operative imaging in Patient 2. (A) Antero-posterior radiograph of the left knee demonstrat-ing a 17 degree valgus deformity. (B) Lateral radiograph of the left knee. (C) Mechanical axis seriesdemonstrating valgus deformity of the left knee.

DISCUSSION

Figure 10. Post-operative imaging in Patient 2. (A) Antero-posterior radiograph of the left knee post TKA.(B) Lateral radiograph of the left knee post TKA. (C) Post-operative mechanical axis demonstrating cor-rection of valgus deformity.

Table IIIPatient 2

72-year-old female with valgus knee

Initial Alignment 17 deg valgus

Difference in alignment as planned (CT) 0.1 deg more valgus than planned

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keeps the art of medicine in the hands ofthe surgeon for final balancing andimplantation. It has been well-establishedthat outcomes of TKA are related to sur-geon experience and volume.21,22 Thisdevice provides a very standardizedapproach for the surgeon in performingTKA and may well help elevate perfor-mance regardless of surgeon volume,while simultaneously personalizing thecuts to the patient’s specific anatomy.The TSolution One® recently received

FDA clearance following an IDE trial andis available for use in the United States. Itspredecessor, ROBODOC® (THINK Sur-gical, Inc.), has been used in more than8000 cases since 2000.23 Song et al. pub-lished a prospective trial involving 100patients; half underwent manual TKAand the other half underwent roboticTKA.19 They found an improved post-operative mechanical axis with fewer out-liers in alignment in postoperative studiesas well as improved PCL tension in therobotic group, with decreased blood loss.Subsequent studies by Liow et al.achieved similar results.6 There were nocoronal-plane outliers in the roboticgroup, compared to 19.4% outliers inthe manual group. They also reportedless joint line shift outliers and lessfemoral notching.6Conversely, Liow et al. also reported a

10% robot abort rate due to technicalerrors and a 6.5% rate of soleal veinthrombosis that may be attributable tothe positioner.6 The increased proceduretime for robotic setup is associated withincreased rates of infection.4,24 In ourstudy, safety was assured by proper pinplacement, appropriate retraction andconsistent technique. In our center, wehad one device-related adverse event(arthrofibrosis requiring manipulationunder anesthesia),which was possiblyassociated with the device or the TKAprocedure. The results from other cen-ters in our FDA IDE trial demonstratefavorable outcomes and accuracy, whichare currently being tabulated and pre-pared for publication in the near future. Currently, hospital systems are being

challenged by the coronavirus disease2019 (COVID-19) pandemic, and allelective orthopedic cases have been can-celled.25-28 While recent trends demon-strate increased rates of adoption oftechnology and a three-fold increase inthe use of technology from 2008 to

2015, decisions to add new technology inthe context of new infection protocols isparamount. Additional operating roomfoot traffic and operative time have beenassociated with increased rates of surgicalsite infection.29,30 However, we hope thatthe greater accuracy and precision pro-vided by robotic technology can help toimprove outcomes, resulting in fewerrevisions and higher patient satisfactionwhile improving efficiency. In a post-COVID-19 world, new technologies willneed to prove their worth, which canhopefully be achieved by further studies.

Conclusion

The TSolution One® is a viableentrant in the US market for robot-assist-ed knee arthroplasty. Adherence to prop-er technique and increased understandingof the nuances of robotics will continueto ensure good outcomes. Only time willtell if introduction of this technology willimprove our care of knee arthroplastypatients, especially post-COVID-19.

Authors’ Disclosure

YK, BS, SK, RL and WL were investi-gators for THINK Surgical, Inc.’s (Fre-mont, CA) FDA IDE Trial. They are alsoconsultants for THINK and have receivedinstitutional support. YK and BS arestockholders in THINK. YK, BS, and WLare members of the speakers’ bureau. VCis an employee of THINK and holds stockoptions. JC, TA and RL declare that theyhave no conflicts of interest.

References

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REFERENCES

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AUTHORS’ DISCLOSURES

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