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105<div class="intro-text">
106<div class="intro-inner">
107<div class="intro-content">
108<h3 class="heading-02">Multi-Centric Clinical Trials of The Indigenous Total Knee Prosthesis 2.4 and Pilot Production of TKP 2.4</h3>
109
110<p>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.</p>
111
112<p>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.</p>
113
114<p>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 &amp; Testing Machine was also designed and fabricated.</p>
115
116<p>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.</p>
117
118<p>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.</p>
119
120<p>This project is one of the major projects under RDD-I category sponsored by the Office of PSA with an<strong> overall outlay of Rs 1820 Lakhs</strong>. <strong>NFTDC  co-funded the project in tune of Rs 550 Lakh</strong>. 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 &amp; PD Hinduja Hospital. </p>
121</div>
122
123<div class="intro-video"><iframe allowFullScreen="" src="https://www.youtube.com/embed/hpBtTdGlU3I?si=f92EckZjgmVAAygr" title="Knee Prosthesis Clinical Trial Video"></iframe></div>
124</div>
125</div>
126
127<div class="milestone-section">
128<div class="milestone">NFTDC project team has accomplished 72 surgeries as on May 2025 and out of that 25 surgeries has completed mandatory 2 years follow up displaying the robustness of the prosthesis. This kind is the first one in India undergoing trials. NFTDC will complete 100 implantations by December 2025. The project team is already under process of obtaining ISO 13485 followed by Manufacturing License. Post obtaining statutory permissions, the project will enter RDD-III category and prosthesis will be offered to open market.</div>
129</div>
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246\r\n    align-items: flex-start;\r\n    background-color: #eef6f9;\r\n    padding: 20px;\r\n    border-radius: 8px;\r\n    margin-bottom: 20px;\r\n    gap: 15px;\r\n  }\r\n\r\n  .milestone.second {\r\n    background-color: #fff2e5;\r\n  }\r\n\r\n  .milestone-icon {\r\n    font-size: 30px;\r\n    width: 40px;\r\n    height: 40px;\r\n    flex-shrink: 0;\r\n  }\r\n\r\n  .milestone-text {\r\n    flex: 1;\r\n  }\r\n\u003c/style\u003e\r\n\u003cdiv class=\"intro-text\"\u003e\r\n\u003cdiv class=\"intro-inner\"\u003e\r\n\u003cdiv class=\"intro-content\"\u003e\r\n\u003ch3 class=\"heading-02\"\u003eMulti-Centric Clinical Trials of The Indigenous Total Knee Prosthesis 2.4 and Pilot Production of TKP 2.4\u003c/h3\u003e\r\n\r\n\u003cp\u003eIn 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.\u003c/p\u003e\r\n\r\n\u003cp\u003eThe 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.\u003c/p\u003e\r\n\r\n\u003cp\u003eThe 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 \u0026amp; Testing Machine was also designed and fabricated.\u003c/p\u003e\r\n\r\n\u003cp\u003eIn 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.\u003c/p\u003e\r\n\r\n\u003cp\u003eThis 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.\u003c/p\u003e\r\n\r\n\u003cp\u003eThis project is one of the major projects under RDD-I category sponsored by the Office of PSA with an\u003cstrong\u003e overall outlay of Rs 1820 Lakhs\u003c/strong\u003e. \u003cstrong\u003eNFTDC\u0026nbsp; co-funded the project in tune of Rs 550 Lakh\u003c/strong\u003e. 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 \u0026amp; PD Hinduja Hospital.\u0026nbsp;\u003c/p\u003e\r\n\u003c/div\u003e\r\n\r\n\u003cdiv class=\"intro-video\"\u003e\u003ciframe allowfullscreen=\"\" src=\"https://www.youtube.com/embed/hpBtTdGlU3I?si=f92EckZjgmVAAygr\" title=\"Knee Prosthesis Clinical Trial Video\"\u003e\u003c/iframe\u003e\u003c/div\u003e\r\n\u003c/div\u003e\r\n\u003c/div\u003e\r\n\r\n\u003cdiv class=\"milestone-section\"\u003e\r\n\u003cdiv class=\"milestone\"\u003eNFTDC project team has accomplished 72 surgeries as on May 2025 and out of that 25 surgeries has completed mandatory 2 years follow up displaying the robustness of the prosthesis. This kind is the first one in India undergoing trials. NFTDC will complete 100 implantations by December 2025. The project team is already under process of obtaining ISO 13485 followed by Manufacturing License. Post obtaining statutory permissions, the project will enter RDD-III category and prosthesis will be offered to open market.\u003c/div\u003e\r\n\u003c/div\u003e\r\n","promo_img":{"url":"https://www.psa.gov.in/CMS/web/sites/default/files/2025-05/young-prosthetist-holding-artificial-leg-2025-03-05-20-18-48-sm.jpg","alt":"Total Knee Prosthesis"},"oneHealthTitle":null,"oneDesc":null,"newsTitle":null,"publisher_image":null,"RtiDisclosure":null,"newsUrl":null,"imgUrl":null,"goal":null,"Critical":null,"Exercises":null,"interestedArticles":null,"nextArticles":null,"relatedArticles":null,"additionalInfo":null,"banner":"","agencies_title":"","national":null,"test_goals_title":null,"goals":null,"goal_section":null,"certical_title":null,"certical_section":null,"exercises_section":{"title":[],"description":[],"body":""},"publication":null,"agencies":null,"team_members":null,"test_banner_image":{"url":"https://psa.gov.in/CMS/web/sites/default/files/2025-05/ban-pro.png","alt":"Total Knee Prosthesis"},"image":{"url":"https://psa.gov.in/CMS/web/sites/default/files/2025-05/young-prosthetist-holding-artificial-leg-2025-03-05-20-18-48-sm.jpg","alt":"Total Knee Prosthesis"},"mobileImage":{"url":"https://psa.gov.in/CMS/web/sites/default/files/article/PowerPoint-Presentation_0.png","alt":"pp"},"metatags":{"title":"Indigenous Total Knee Prosthesis 2.4 | Principal Scientific Adviser","description":".intro-text { background-color: #f9f9f9; padding: 20px; margin-bottom: 30px; } .intro-inner { display: flex; flex-direction: row; gap: 20px; flex-wrap: wrap; } .intro-content { flex: 1 1 300px; } .intro-video { width: 550px; flex-shrink: 0; } .intro-video iframe { width: 100%; aspect-ratio: 16 / 9; border: none; } @media (max-width: 768px) { .intro-inner { flex-direction: column; } .intro-video { order: 2; /* Show video after text on mobile */ width: 100%; ma","robots":"noindex, nofollow","canonical_url":"https://www.psa.gov.in/article/indigenous-total-knee-prosthesis-24/9516"}}},"id":"9516","pageTitle":"Indigenous Total Knee Prosthesis 2.4"}}},"page":"/article/[...pid]","query":{"pid":["indigenous-total-knee-prosthesis-24","9516","9516"]},"buildId":"gAsymnpIf5kdrzsw8ps7t","isFallback":false,"isExperimentalCompile":false,"gssp":true,"appGip":true,"scriptLoader":[]}</script>
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