Indigenous Total Knee Prosthesis 2.4

Multi-Centric Clinical Trials of The Indigenous Total Knee Prosthesis 2.4 and Pilot Production of TKP 2.4

In 2016, the project was sanctioned to the Non-Ferrous Materials Technology Development Centre (NFTDC), Hyderabad with joint funding by NFTDC and the Office of PSA, initially for a period of 4 years. Later, the project extension was accorded till July 2022.

The project aimed at demonstrating the safety and functional efficacy of limb sparing surgery and reconstruction with distal femur prosthesis implanted in patients with distal femur tumours. The objective of this project is to ensure end-to-end technology development of medical devices‚ along with its armamentarium and a complex test bed with validation of detailed risk analysis in empirical, long-duration tests.

The knee prosthetic implant is designed to restore all functional requirements together with a long service life of 10+ years. This state-of-art medical device is biomechanically closest to the natural knee, with the implant axis coinciding with the anatomical axis and joint line. Furthermore, the implant features high precision nano-finish and lowest wear rate. Notably, a specialised Knee Simulator & Testing Machine was also designed and fabricated.

In the second phase of the project, clinical trials of the device, armamentarium and Knee Testing Machine were conducted at AIIMS New Delhi, TMC Mumbai, and Hinduja Hospital Mumbai and at two more centres in east and south of India.

This implant is the first indigenous medical device cleared (on 22nd June 2018) under Medical Device Rules, which came into effect in January 2018, for Multi-Centric Clinical Trials. Despite pandemic-induced disruptions, the clinical trial has proceeded at the above three centres and nearly 30 implantation surgeries have been successfully completed as of November 2022.

This project is one of the major projects under RDD-I category sponsored by the Office of PSA with an overall outlay of Rs 1820 Lakhs. NFTDC  co-funded the project in tune of Rs 550 Lakh. The project aimed at Pilot Production of an indigenously patented Total Knee Prosthesis (TKP2.4) and Multi-centric Clinical Trials of spanning three institutes, namely at AIIMS, Delhi, Tata Memorial Centre Mumbai & PD Hinduja Hospital.