Medtronic’s CD Horizon™ ModuLeX™ 5.5 Spinal System has been developed as a headless in-situ modular attachment solution to offer increased visualization of the surgical working area compared to a pre-assembled screw, and the ability to intraoperatively assemble solutions to meet a wide variety of treatment goals. The CD Horizon™ ModuLeX™ 5.5 Spinal System is compatible with all 5.5 rods within the CD Horizon™ product family and is integrated for use with Medtronic’s advanced surgical technologies, including O-arm™ imaging, StealthStation™ navigation systems and Powerease™ System
This interview is conducted with Daniel Spomar, MD (Section Chief of Neurosurgery at Franciscan Health Indianapolis and Staff Neurosurgeon at Goodman Campbell Brain and Spine) and Joseph Osorio, MD, PhD (Assistant Professor of Neurological Surgery, Director, Spinal Oncology and Deformity Surgery, UC San Diego Health). They were asked 5 questions about how they use ModuLeX™ 5.5 in their practice and the benefits they have seen from it. Doctors Spomar and Osorio are paid consultants for Medtronic.
What benefits does ModuLeX™, a modular screw system, bring to your OR?
Dr. Spomar: “The main benefit of the ModuLeX™ 5.5 modular screw system is having the ability to place my screws first with navigation, then easily work around the screws. This includes being able to do a precise decompression and decortication of bone structures, the facet joints, and transverse processes without any interference from the tulip heads,” which can occur with a preassembled system. Additionally, “the ModuLeX™ 5.5 system provides for excellent low-profile distraction of the screws while performing interbody work. After the decompression, decortication and fusion is performed, the tulip heads and rods can be placed
Dr. Osorio: “ModuLeX™ 5.5 is a great platform for utilization with the Mazor™ Robot platform system, it is the reason why I introduced it into my practice. I was seeking a platform that would allow me versatility to place a pedicle screw without the inconvenience of the tulip head causing a physical obstruction to the bone work within a surgical plan; this would include osteotomies, decompression, and decortication. Prior to ModuLeX™ if I needed to perform osteotomies, I simply would not place screws with tulip heads prior to my bone work, and this would not allow the workflow of utilizing my preoperative planned screws. ModuLeX™ allows the surgeon to place the screw early in a case and use the workflow of preoperative CT planning to intraoperative X-ray registration within the Mazor™ platform, which I feel is a major advantage in OR time efficiency. Additionally, it allows the streamline capability for the tech assisting the surgeon to simply focus on the shank size and this limits the implant bandwidth for the tech making workflow efficiencies at the time of screw placement. In the near future, there will be other options that span beyond the current tulip head capabilities.”
In what type of procedures do you use ModuLeX™ 5.5?
Dr. Spomar: “I use the ModuLeX™ 5.5 modular screw system for all instrumented thoracic and lumbar cases. The system is especially helpful when performing a mini open, ‘midlif’ approach for lumbar fusion. With a small working space, there is no interference from the tulip heads while performing the procedure.”
Dr. Osorio: “At this time I use ModuLeX™ 5.5 for all my degenerative spine cases because I find that within a limited corridor it is beneficial to have a shank that will allow for unobstructed decortication of the transverse processes, interbody placement, and decompression. The open TLIF has been a case that has easily benefited from this new platform in my cases, and this has allowed me to maintain a smaller incision without the common struggles that come from working in a small corridor. Additionally, in an educational setting with resident and fellow surgeons the screw shanks provide a critical landmark with the pedicle being highlighted and this aspect is very navigating to the assistant surgeon. I have also incorporated it into the adult spinal deformity cases because it allows the capability to place pedicle shank in revision settings around pre-existing hardware in regions that do not have prior screws placed within a limited corridor where a tulip system would have been limited because of prior hardware. In addition to the above traditional approaches, I find that I am using the cortical screw trajectory for cases that are single level in deeper patients allow not only a limited incision, but this also comes with the added benefit that an adequate limited working corridor in a larger patient provides a smaller incision which is better for the higher risk patient - especially for wound healing.”
Can you please describe your confidence in the connection between the head and the shank?
Dr. Spomar: “Compared to other modular screw systems I have used in the past, the connection between the head of the screw and the shank is very robust. Once the head is applied to the shank, the connection between the head and the shank is secure. There is reliable tactile feedback that is received when the head is applied to the shank with the application tool. It is easy to tell if the head has been properly secured to the shank.”
Dr. Osorio: “The connection and confidence between the head and the shank is something that I have not doubted since the moment I felt the connection and realized that there is positive feedback that is felt from the head engagement from the time that the surgeon ‘snaps’ on the head to the final placement and release of the tulip. There are times where I have not had the tulip engage and this also was reassuring because it was easily noted that the reason for this was that I countersunk my shank too deep, and there was bone limiting the head connection – which was easily solved with a reamer. Going through each of these scenarios above, which all happened within my initial cases, has provided the extreme confidence to continue to utilize this system.”
Does using ModuLeX™ 5.5 limit you in any way in your practice?
Dr. Spomar: “Using the ModuLeX™ 5.5 system has not limited my practice in any way but rather has enhanced it. It is much less cumbersome to work around the posted screw versus the screw with the head already attached. This allows for the case to proceed more efficiently in my experience. Also, the amount of time to apply the heads to the screws is minimal.”
Dr. Osorio: “There are nearly no limitations that currently exist in my practice because of the efficiency gained in simply placing screw shanks that I have realized during the screw placement. From my initial adoption, my spine tech passing the implants has been more efficient because the focus is just on screw diameter and length as opposed to additionally searching for the screw type with tulip preference, and this has easily made up for the limited time needed to place the heads at the end of the case.”
ModuLeX™ 5.5 not only has modular implants but also provides modular instrumentation. Can you tell us the benefits either the retractor or the distractor has brought to your practice?
Dr. Spomar: “The benefits of the retractor are, it is an elegant way to provide excellent exposure of the spine for a one level decompression and instrumented fusion with minimal soft tissue disruption. It provides superb visualization of the anatomical structures, and it is versatile in terms of providing the optimal amount of exposure for patients regardless of their size. I especially enjoy using the distractor system because it allows for a very low-profile distraction of the pedicle screws. There are several options included in the system which allow for significant versatility. I especially like using the hooks and the cable attachments for distraction. The distraction system is adjustable for the depth of the wound as well. Other distractors that I have used with modular systems can easily become disengaged from the shanks of the screws. The attachments of the ModuLeX™ 5.5 distractor system provide a solid connection to the screws and never become disengaged from the screws when I need distraction. “
Dr. Osorio: “Within my current TLIF workflow, which has now consistently incorporated the ModuLeX™ system, I find that using the shank distraction instrumentation allows for an even wider working corridor than what I was used to previously. Commonly, during an open TLIF I would use a tulip distraction mechanism that was bulkier, and the ModuLeX™ distractor allows for a distraction mechanism that has variable attachments for distracting the shanks that is not only easy to engage, but it also provides improved visibility.”
Indication:
“CD Horizon™ Spinal System intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine. Mazor™ X system indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery. Used in open or minimally invasive or percutaneous procedures. Refer to product indication manual for instructions, warnings, precautions, and contraindications.”