World-Class Tumor Knee Prosthesis: Made in India.

Area of Science:

• Orthopedic Oncology
• Biomedical Engineering
• Materials Science

Background:

• Limb-saving surgeries for osteosarcoma often require large bone gap reconstruction using mega-prostheses.
• The development cycle for these prostheses is lengthy and costly, with Western designs often being unsuitable and unaffordable for Indian patients.
• There is a critical need for cost-effective, high-quality prostheses tailored to the local Indian population's anatomy and function.

Purpose of the Study:

• To address the unmet need for affordable and high-quality mega-prostheses in India.
• To develop a novel modular tumor knee prosthesis and associated surgical armamentarium.
• To create a prosthesis compatible with the local population's anatomical and functional requirements.

Main Methods:

• An inter-disciplinary team of orthopedic oncologists, mechanical engineers, and materials scientists collaborated.
• A modular tumor knee prosthesis with a rotating hinge and specialized surgical instruments (cutting jigs) were designed and developed.
• A dedicated pilot production facility, quality management system, knee simulator, and testing machines were established.

Main Results:

• The novel prosthesis offers up to 120 degrees of flexion-extension and ±5 degrees of axial rotation.
• It successfully passed rigorous fatigue and wear testing, completing ten million cycles.
• Human clinical trials have been approved by regulatory bodies and are currently underway.

Conclusions:

• The decade-long development involved overcoming significant challenges through technological innovation and surgeon feedback.
• The successful design, manufacturing, and testing pave the way for improved treatment options.
• This experience offers valuable insights for future endeavors in developing specialized medical devices.