Limbsal Ortho

Introduction

Incredible AM Pvt. Ltd. is the first company in India working exclusively with Medical 3D printing in a certified world-class facility. The company has built the facility as per FDA norms. It is certified with ISO 13485 and ISO 9001. Key features include a Class 10000 clean room, US-FDA approved software, state-of-the-art equipment, and an excellent team of doctors, engineers, biomedical engineers, CAD designers, and medical consultants. They are dedicated to delivering outstanding services to doctors, hospitals, and patients with complete validation and tests conducted to certify the process and product. Incredible deals with Customized Implants, Standard Implants, Bio models, as well as Cutting Guides.

Background

A male patient of 7 years old, hailing from Mumbai, Maharashtra, a student, was diagnosed with Periosteal Ewing's Sarcoma of the right femur. The patient underwent Neoadjuvant Chemotherapy as part of the treatment protocol. After 9 cycles of NAC, shrinkage of the soft tissue mass and bone edema was noted. There was also resolution of periosteal reaction, all pointing to a favorable response to chemotherapy.

Dr. Manish Agarwal, India's leading Onco Orthopedic Surgeon at P. D. Hinduja Hospital, Mumbai, Maharashtra, decided to proceed with tumor resection followed by reconstruction using ECRT-treated bone. Customized cutting jigs and a patient-specific implant were utilized to ensure better fixation of the resected tumor bone segment back into position post-radiation.

Solution

Dr. Manish Agarwal, India’s leading Onco Orthopedic surgeon in Mumbai, Maharashtra, and a pioneer in ECRT-aided tumor bone surgeries, studied the medical history, imaging, and histopathology reports of the 7-year-old patient. It was decided to proceed with the ECRT treatment protocol. The main challenge was to salvage the growing epiphyses in the patient's femur, which required the use of patient-specific cutting guides and a patient-specific femur implant.

The Incredible team collaborated with Dr. Agarwal to design and manufacture the necessary surgical tools and implant. The process started with surgical planning and case simulation using US FDA and CE-approved Materialise Mimics software, which integrated CT and MRI DICOM data with the anatomical model. The anatomical model maintained a 1:1 ratio with the patient’s anatomy, providing an accurate representation of the defect and serving as the basis for designing the cutting guides and implant on the actual bone. This pre-surgical planning proved vital in ensuring precision during the surgery.

Once the planning was finalized, the surgery was carried out with the use of the customized implant, cutting guides, and jigs. The customized jig helped in precise cutting of bone tissue and was made from biocompatible, autoclavable Nylon material. The design of the implant was a collaborative effort between Dr. Agarwal and the Incredible design team.

The benefits of using a 3D-printed implant lay in its customization to the patient's anatomy, providing a perfect fit. The varying sizes of the implant helped strengthen the specific areas of the femur that required support. A Finite Element Analysis (FEA) was carried out to assess the strength, stability, and functionality of the implant. A key feature of the design was the pre-planned screw trajectory, which was defined by the surgical team to avoid the physes and ensure maximum bone purchase. The combination of combi and locking holes ensured a strong, stable hold of the bone fragments.

Quote from Doctor

“Custom plate allowed us to preserve the growth plate. We could customize the locking by predeciding the screw direction and position within bone. The custom plate fits the deformed bony contours and aids reduction.”

Conclusion

The implant was manufactured under ISO 13485 guidelines and tested to ensure an accurate fit and utmost safety. Cutting guides and jigs from 3D Incredible helped the surgeon make precise cuts and complete the surgery in one go. Once the resection was done, a customized implant from 3D Incredible was implanted.

The implant was manufactured using Ti6Al4VELI, a biocompatible material, tailored to the patient's anatomical requirements, contour, and bone thickness. This implant, along with the customized cutting jig, reduced the need for further adaptation of standard implants on the operating table, ultimately reducing the time spent in the operating room.

The implant also features a novel C-arm/clamp design on the proximal and distal parts of the plate, ensuring proper holding of the plate to the bone fragment. This design enhances faster recovery post-ECRT surgery, as the entire process was completed in a single surgery.

At Incredible AM Pvt Ltd, rigorous testing and validation of its plant, equipment, and processes are carried out to ensure the safety and quality of the implant.