Arthroscopic Instruments to Support New Surgical Methods in Hip Arthroscopy
Project Abstract:
About one half million hip joint replacements occur each year with 99 of them occurring due to arthritis related pain and limitations Before these costly and invasive hip replacement surgeries action can be taken by addressing the underlying condition within the hip joint through an arthroscopic hip surgery Today there are no commercially available arthroscopic tools to deliver bone graft to cysts within the hip joint We intend to develop the Subchondral Cyst Tool Set to serve arthroscopic surgeons providing preventative surgeries for young and active patients with hip joint pathologies The Subchondral Cyst Tool Set consists of five distinct tools which enable this novel surgical method like the slotted cannula to provide access to the joint and bone graft tool to deliver bone graft material to the cystic void We propose to conduct three aims over two years with 198509 in support from the SPARK program Aim 1 focuses on the manufacturing of repeatable and reliable tools using our third party medical device manufacturer GoNo Go decision based on quality control of tool prototypes Aim 2 includes regulatory efforts to complete packaging labeling steriliz ation and shelf life validation tests for the tool set GoNo Go decision based upon successful validation test results Aim 3 entails the first in human trials of the tool set COMIRB Protocol 19 2755 to collect critical clinical data to confirm improved patient outcomes and reduced surgical time GoNo Go decision based on statistical significance of the clinical trial results Dr Segil is an Assistant Research Professor in the Biomedical Engineering Program at CU Boulder and has extensive entrepreneurial experience including 5 patents 4 medical devices taken to market 2 companies formed previously over 4 million raised through SBIRSTTR awards and 1 multi million dollar exit to a Fortune 500 company Dr Omer Mei Dan MD is an Israeli and American board certified orthopedic surgeon leading the University of Colorado Hip Preservation service His entrepreneurial activities have been wildly successful including the rapid sale of MITA to Stryker in 2016 alongside Dr Segil His close industry ties and world wide reputation as a leader in hip arthroscopy are critical assets to this project
