Summary The VIRTUGUIDE™ System includes a pre-operative AI powered planning software that suggests a patient-matched Virtual Alignment Correction (VAC) Guide used for Lapidus arthrodesis procedures. The VIRTUGUIDE™ pre-operative planning software utilizes AI to analyze the patient’s foot anatomy by identifying specific landmarks. The software generates a plan of the surgery and helps in the selection of a patient matched VAC Guide. The VAC Guide incorporates the correction Intermetatarsal (IM) and Frontal Plane (FP) angles for the patient to allow wire placements in the specific deformity positions required for the correction. Related Implants (Implants are not part of the VIRTUGUIDE System.) DYNABUNION™ Plates and other staple compression plates TriLEAP™ Plates Continuous Compression Implants Cannulated Screws General Lapidus Indications 1st TMT arthrodesis (Lapidus) indications severe deformity (HVA > 40 degrees, IMA > 20 degrees) arthritis at TMT joint or ligamentous laxity note: VIRTUGUIDE System is for hallux valgus only Open Anatomy Osteology first tarsometatarsal (TMT) joint articulation between the medial cuneiform and base of the first metatarsal primary stabilizer of the medial column and first ray Osseous medial cuneiform base of the first metatarsal relationship to the second metatarsal contributes to midfoot stability Ligaments dorsal and plantar TMT ligaments plantar restraints stronger than dorsal restraints Nerves deep peroneal nerve adjacent to dorsalis pedis artery saphenous and superficial fibular nerves at risk during dorsal approach Blood Supply dorsalis pedis artery traverses dorsal aspect of the first TMT joint Reference Lui TH, Chan KB, Chan LK. Arthroscopic Lapidus Arthrodesis of the First Tarsometatarsal Joint for Treatment of Hallux Valgus Deformity of the Foot. Arthrosc Tech. 2022;11(6). Preoperative Planning Imaging parameters the VIRTUGUIDE™ Software is configured to accept weight bearing CT scans and AP X-rays of the entire foot weight bearing may influence the deformed anatomy and therefore provide a more accurate analysis of the deformity correction needed Imaging x-ray must be calibrated before being analyzed by the software scaling factors must be defined using an option in the software must be calibrated prior to software analysis using X-ray scaling factors to enable AI-automated measurements in mm this will allow AI-automated analysis of the measurements in mm if you do not have the magnification factor, you can set a default value if you do so, the software will not display any measurements in mm and will show only the calculations for the various angles CT while Standard CT scans can be uploaded, they may result in a less desired deformity correction when performing scans and gathering files, ensure the images meet noted image requirements in the adjacent table Surgical Approach Dorsomedial incision create a dorsomedial incision that is approximately 20 degrees from direct dorsal and medial to the extensor hallucis longus the incision should be 3-4cm in length retract the skin incision laterally create a small direct dorsal stab incision into the TMT joint capsule to expose access to the joint the size of this incision should be just large enough to fit the paddle of the Joint Seeking Pin Guide do not expose and mobilize the entire joint capsule and do not place an osteotome into the joint the joint space should still be tight Surgical Technique Placement of joint seeking pin and VAC Guide place Joint Seeking Pin Guide into the TMT joint where the stab incision was made the Joint Seeking Pin can be inserted either using the Wire Driver of the Power Tool or a Mallet assemble distal Insert into the VAC Guide slide the VAC Guide over the Joint Seeking Pin through the central hole until the Guide is in apposition with the foot in the Cuneiform, place a long 2.0mm Wire first proximally (1), then a short 2.0mm Wire distally (2) in the Metatarsal, place a short 2.0mm Wire proximally (3), then a long 2.0mm Wire distally (4) Cut guide for bone resections dissect the joint capsule to expose the joint place the Cut Guide over the Metatarsal Wires through the holes marked “0” apply the Cut Guide on the proximal Wires and resect the bone of the Cuneiform Realignment and compression with RAC Block apply pressure to the medial aspect of the first Metatarsal squeezing towards the 2nd Metatarsal to allow ease of placement of the RAC Block slide down RAC Block over all 4 Wires to compress joint space and generation correction and alignment verify desired correction has been achieved by assessing Intermetatarsal and Frontal Plane angles under fluoroscopy verify if desired compression is achieved under AP and lateral fluoroscopy by verifying apposition of joint surfaces if additional compression is needed, remove 0 - RAC Block (Standard) and replace with a 1 - RAC or 2 - RAC Block for greater compression until apposition is achieved Fixation the VIRTUGUIDE™ Instruments are compatible with a range of DePuy Synthes Lapidus fixation options Technical specifications VAC Guide patient-matched to deformity and incorporates IM and FP angles for wire placement in correction-specific positions 3D printed and supplied sterile packed single patient use only and must never be reused instrument kits are available as left- and right-foot options across multiple IM and frontal plane angle combinations Disposable and reusable instrumentation disposable instruments include patient-matched VAC guide, 2.0 mm K-wires with trocar in 102 mm and 152 mm lengths, long sawblade, and Joint Seeking Pin reusable instruments include the cut guide, Universal Handle, and RAC blocks, supplied via a modular tray system Realignment and Compression (RAC) Block options 0, 1, and 2 levels of compression 0, 5, and 10 degrees of additional frontal plane rotation, with left, right, and universal configurations depending on the block Disclaimers The VIRTUGUIDE Pre-operative Planning Software, powered by PeekMed®, is developed and owned by Peek Health, S.A. Important Information: Prior to use, refer to the instructions for use supplied with the device(s) for indications, contraindications, side effects, warnings and precautions. The third-party trademarks used herein are the trademarks of their respective owners.