Charles Sternberg, Associate Editor11.02.22
In June of this year Red Point Medical 3D (RPM-3D) received FDA clearance to market patient specific bone cutting guides for use in foot and ankle reconstructive surgeries such as bunion correction for both adult and pediatric patients down to the age of 12.
The first family of RPM-3D customized guides is being marketed as The Better Bunion which allows surgeons to utilize only 6 steps to prepare the bone before focusing on their preferred fixation. The optimized, hardware-agnostic Better Bunion technique results in quicker surgery with less dissection, eliminates the need for cross-metatarsal clamps, and is designed to lead to a more precise outcome with a faster recovery. Each case is fully tailored to match both the patient’s needs and the surgeon’s preferences. The PSI system has been growing nationwide and is already benefiting many of the 450,000 patients who undergo bunion surgeries each year.
Now, the RPM-3D PSI cut guide system is expanding into new territory with the introduction of the RPM-3D Intelliguide System, an advanced patient-specific deformity correction system. Using the power of AI-enabled surgical planning software, customized surgical techniques, and custom 3-D printed cutting guides, complex deformity correction is now more streamlined and accurate than ever before.
Advantages of using RPM Intelliguide cut guides versus traditional standard instrumentation (SI) include:
The first family of RPM-3D customized guides is being marketed as The Better Bunion which allows surgeons to utilize only 6 steps to prepare the bone before focusing on their preferred fixation. The optimized, hardware-agnostic Better Bunion technique results in quicker surgery with less dissection, eliminates the need for cross-metatarsal clamps, and is designed to lead to a more precise outcome with a faster recovery. Each case is fully tailored to match both the patient’s needs and the surgeon’s preferences. The PSI system has been growing nationwide and is already benefiting many of the 450,000 patients who undergo bunion surgeries each year.
Now, the RPM-3D PSI cut guide system is expanding into new territory with the introduction of the RPM-3D Intelliguide System, an advanced patient-specific deformity correction system. Using the power of AI-enabled surgical planning software, customized surgical techniques, and custom 3-D printed cutting guides, complex deformity correction is now more streamlined and accurate than ever before.
Advantages of using RPM Intelliguide cut guides versus traditional standard instrumentation (SI) include:
- Improved Predictability and Reproducibility: Intelliguide cut guides allow for accuracy in addressing angular deformity by providing the ability to pre-configure the exact cut angles needed to correct a deformity. Since the cut angles have been rehearsed (digitally and/or with a 3D-printed replica model), once the PSI based guide is placed on the bone, the cut angles can be performed within .02 degrees of the planned cuts (per RPM-3D’s FDA lab data submission). Surgeon experience and skill does impact the ability to achieve desired cut angles when free handing the same cut using (SI) methods.
- RPM custom cutting guides are hardware agnostic: This allows for accurate and customized instrumentation that is pre-configured to assist the surgeon/surgical team with intra-operative surgical accuracy. Once the deformity is corrected using the preconfigured cut guides, the surgeon can then select fixation hardware based on their own surgical preferences and/or based on favorable contracts at each individual surgical facility, potentially providing cost-savings over competitors.
- Cost Reduction: When compared to other instrumented systems (which includes proprietary hardware), RPM-3D cut guides plus a modestly priced plating system will have advantages in customization and pricing, while giving the surgeon greater accuracy, simplicity, and the ability to choose their own hardware configuration. In regard to the other Intelliguide cut guides, the cost reduction will be in reduced operating room times, more precise hardware placement and flexibility, and greater ability to handle complex deformity corrections in a single-staged procedure compared to conventional methods which often require a second stage due to surgical inaccuracies or inability to gain proper re-alignment with eye-balling the correction and free-handing the reduction.
- Reduction of X-ray exposure: PSI instrumentation and accurate pre-operative planning reduces the reliance on intraoperative imaging for correctional assessments when compared to traditional SI techniques.
- Reduction in Surgical times: When compared to other, non-PSI instrumented techniques (bunion correction), PSI enabled cut guides can significantly reduce the total incisional time by reducing the time it takes to cut and reposition the bone/joint and mounting hardware. Precise cuts provided for the other PSI enabled techniques also streamline the steps it takes to correct the deformity when compared to traditional SI methods (examples: calcaneal osteotomy, distal tibial osteotomy, and complex midfoot osteotomies). Reduction in surgical times will allow for surgical facilities to book more cases/realize increased revenue with the more predictable nature of PSI compared to the use of traditional SI when it comes to complex deformity corrections.
- Hardware planning: Although RPM3-D’s PSI methods are hardware agnostic at this time, if the surgeon can identify what hardware will be used in advance, RPM3D can help to orient/guide pre-drilling for fixation and pre-determine details such as screw lengths needed, depth of saw cuts, and orientation for optimal fixation, further improving the surgeon’s intraoperative efficiency while reducing potential errors and costs associated with inaccurate measurement using traditional screw measuring SI and costly “in & out” hardware.
- Reduced intraoperative stresses associated with complex deformity correction: In over 40 cases performed using RPM3D’s PSI, surgeons reported a significant reduction in stress associated with the surgical technique aided by PSI versus the traditional methods related to SI and free handing osteotomies.
- Improved patient and surgeon satisfaction: In the over 50 cases performed with RPM’s PSI, patient satisfaction rates have been extremely high due to the ability to see their surgery in detail before it is actually performed, and the knowledge that their surgeon will have instrumentation that has been optimized for both their deformity and unique anatomy. Although there are additional pre- operative steps involved in the planning of a PSI case, surgeons have been satisfied with the more streamlined and reproducible intraoperative steps when compared to doing the same type of osteotomy either free handed or with traditional SI.