Limb Salvation Surgery in Bone Cancer Treatment

Implant Specifications:

Name of the surgeon : Dr. Manish Agarwal
Place : P. D. Hinduja Hospital, Mahim, Mumbai
Implant size : 55.06*44.34*220.3223
Surface finish : Matt finished both side
Material : Patient specific anatomy model, customized bone resection jigs, patient specific implant

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 includes Class 10000 clean room, US-FDA approved software, state of the art equipment and also an excellent team of doctors, engineers, biomedical engineers, CAD designers and medical consultants who are there to deliver outstanding services to doctors, hospitals& patients with complete validation & tests conducted to certify the process & product. Incredible deals with Customized Implants, Standard Implants, Bio models as well as Cutting Guides.

Tumor in left femur region

Background :

A male patient of 7-year-old hailing from Mumbai, Maharashtra, a student, was diagnosed with Periosteal Ewing`s Sarcoma of Right femur. Patient underwent Neoadjuvant Chemotherapy as part of treatment protocol. After 9 cycles of NAC, shrinkage of soft tissue mass and bone edema was noted. There was resolution of periosteal reaction as well, all pointing to a favorable response to chemotherapy. Dr. Manish Agarwal, India’s Leading Onco Orthopedic Surgeon in P. D. Hinduja Hospital, Mumbai, Maharashtra decided to go for tumor resection followed by reconstruction using ECRT treated bone where customized cutting jigs & customized implant will help in better fixation of resected tumor bone segment back to the position post radiation.

Solution:

Dr. Manish Agarwal, India’s leading Onco Orthopedic surgeon in Mumbai, Maharashtra being a pioneer in treated tumor bone/ECRT aided surgeries studied medical history, imaging and histopathology reports. It was decided to proceed with ECRT line of treatment. The challenge was to salvage growing epiphyses in this 7 year-old boy’s femur thus using patient specific cutting guides and patient specific femur implant. Incredible team discussed with Dr. Agarwal, the designing and entire manufacturing process. It was initially started with surgical planning and case simulation with the help of US FDA & CE approved Materialise Mimics software by superimposing CT & MRI DICOM data & Anatomical Model. As Anatomical model maintained 1:1 ratio with the anatomy, hence showed excellent detailing of the defect, the model was also used to design jigs & implant on actual bone, which further helped the pre surgical planning. Once the planning was finalized, the surgery was accompanied with not only Customized Implant but also Cutting guides & Jigs. Customized Jig helped in precise cutting of bone tissue, and are manufactured using biocompatible Nylon material which is autoclavable. The design was completed with valuable inputs between the doctor and the Incredible design team together. The benefits of a 3D printed implant was its customization which resembled not only the anatomy but also gave a perfectly fitting implant. The variable sizes helped in strengthening the particular area required. Finite Element Analysis was carried out which to determine the strength, stability and functionality of the implant. The specialty of the design was the pre-planned screw trajectory which was defined by surgeon team to avoid physes and to achieve maximum bone purchase. Excellent combination of combi and locking holes provided to ensure strong and stable hold of bone fragment.

Cutting guide Jigs & Implant Design

Cutting guide jigs & implant

Intra-Op resected & radiated bone tumor fragment

Implantation of femoral implant

Immediate Post- OP radiographic Images

Post- OP radiographic images showing fusion of bone (4-6 months later)

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:

Implant was manufactured under ISO 13485 guidelines & tested to give an accurate fit & utmost safety. Cutting Guides and Jigs from 3D Incredible helped the Surgeon to give an accurate cut and complete the surgery in one go. Once the resection was done, customized implant from 3D Incredible was implanted. Implant was manufactured using Ti6Al4VELI, a biocompatible material; as per anatomical requirement, contour and bone thickness which are patient specific. 3D Incredible customized cutting jig and customized implant helped to reduce OT as there was no further adaption of standard implant required on OT Table. Implant has novel C arm/clamp design on proximal and distal part of plate to ensure proper holding of plate to the bone fragment to enhance faster recovery of femur post ECRT surgery. As the entire process was carried out in one surgery. At Incredible AM Pvt Ltd rigorous testing & validation of its plant, equipment and process is carried out to ensure safety and quality of the Implant.