{"id":111302,"date":"2023-04-27T15:34:41","date_gmt":"2023-04-27T19:34:41","guid":{"rendered":"https:\/\/www.hajim.rochester.edu\/senior-design-day\/?p=111302"},"modified":"2024-03-01T15:26:00","modified_gmt":"2024-03-01T19:26:00","slug":"restable","status":"publish","type":"post","link":"https:\/\/www.hajim.rochester.edu\/senior-design-day\/restable\/","title":{"rendered":"ReStable"},"content":{"rendered":"\n

Meet the Team<\/h2>\n\n\n
\n
\"\"<\/figure>\n<\/div>\n\n\n

Background<\/h2>\n\n\n\n

Wedge Deformities<\/strong>: Also known as the Wedge Effect. Characterized by the distraction of the proximal femur and lateralization of medullary nails within the femur. \u200b<\/p>\n\n\n\n

\u200b<\/p>\n\n\n\n

Why is it a Problem?<\/strong>\u200b<\/p>\n\n\n\n

    \n
  • Fracture becomes fixed in varus reduction\u200b<\/li>\n\n\n\n
  • Changes biomechanical fixation parameters\u200b<\/li>\n\n\n\n
  • Leads to implant failure or revision surgery<\/li>\n<\/ul>\n\n\n\n
    \n
    \n
    \"\"<\/figure>\n<\/div>\n<\/div>\n\n\n\n

    Clinical Scenario <\/h2>\n\n\n\n

    How Does it Happen?<\/strong>\u200b<\/p>\n\n\n\n

      \n
    • Region of dense bone in superolateral femoral neck deflects path of reamer\u200b<\/li>\n\n\n\n
    • Only visible upon full insertion of medullary nail, surgeon must repeat reaming step<\/li>\n<\/ul>\n\n\n\n
      \"\"<\/figure>\n\n\n\n

      Gaps in Current Solutions:<\/strong>\u200b<\/p>\n\n\n\n

        \n
      • Increased physiological burden\u200b<\/li>\n\n\n\n
      • May require an assistant to manually hold instruments\u200b<\/li>\n\n\n\n
      • Solutions are implemented only after the problem occurs<\/li>\n<\/ul>\n\n\n\n
        \"\"<\/figure>\n\n\n\n

        Market Opportunity\u200b<\/h2>\n\n\n\n
          \n
        • Total addressable market: $6.4 billion global hip fracture treatment<\/li>\n\n\n\n
        • Serviceable available market: $2.52 billion in spent on costs associated with hip fracture treatment with IMN<\/li>\n\n\n\n
        • Serviceable obtainable market: $9.3 million (1800 devices and 150,000 disposables)<\/li>\n\n\n\n
        • <\/li>\n<\/ul>\n\n\n\n
          \"\"<\/figure>\n\n\n\n

          The Solution<\/h2>\n\n\n\n

          The WedgeWise Clamp:<\/strong> An orthopedic clamp for reducing fragments of the proximal femur during IM reaming\u200b<\/p>\n\n\n\n

          Components:<\/strong>\u200b<\/p>\n\n\n\n

          A: Stainless Steel Head Piece\u200b<\/p>\n\n\n\n

          B: Stainless Steel Nut\u200b<\/p>\n\n\n\n

          C: Polyethylene Body\u200b<\/p>\n\n\n\n

          D: Polyethylene Handle<\/p>\n\n\n\n

          \"\"<\/figure>\n\n\n\n

          How it Works<\/strong>:\u200b<\/p>\n\n\n\n

            \n
          • Tightened into place around tip of trochanter \u200b<\/li>\n\n\n\n
          • Body component extracted\u200b<\/li>\n\n\n\n
          • Handle and body removed from surgical site\u200b<\/li>\n\n\n\n
          • Cannulation allows reaming to take place unobstructed <\/li>\n<\/ul>\n\n\n\n
            \"\"<\/figure>\n\n\n\n

            A<\/strong>dvantages:<\/strong>\u200b<\/p>\n\n\n\n

              \n
            • No additional incisions  \u200b<\/li>\n\n\n\n
            • Does not require an assistants help \u200b<\/li>\n\n\n\n
            • Designed to prevent wedge deformities from occurring in the first place   <\/li>\n<\/ul>\n\n\n\n

              Proof of Concept Testing <\/h2>\n\n\n\n

              Comparing Clamping Forces:<\/strong> Placing a calibrated pressure sensor in the wedged bone fracture and taking repetitive\u200b measurements for the different clamping methods. \u200b
              Results: <\/strong>Significant difference between clamping \u200b and no clamping \u200b Non-significant difference between metal clamp \u200b and our prototype<\/p>\n\n\n\n

              \"\"<\/figure>\n\n\n\n

              Comparing Wedge Size Detection:<\/strong> Placing a calibrated pressure sensor with known reference values to wedge size and taking repetitive measurements for the different clamping methods \u200b \u200b
              Results:<\/strong> Significant difference between clamping and no clamping for P \u2264 0.0001 \u200b. Significant difference between the metal clamp and prototype for P \u2264 0.05 \u200b<\/p>\n\n\n\n

              \"\"<\/figure>\n\n\n\n

              Next Steps<\/h2>\n\n\n\n

              Regulatory Pathway: <\/strong>\u200b<\/p>\n\n\n\n

                \n
              • Class II Device \u2013 CFR 878.4800, product code -HXD\u200b<\/li>\n\n\n\n
              • 510(k) Pathway\u200b<\/li>\n<\/ul>\n\n\n\n

                Testing:<\/strong>\u200b<\/p>\n\n\n\n

                  \n
                • FDA required testing following the Standard Specification and Test Methods for External Skeletal Fixation Devices, cortex clamp ( ASTM F 1541,  6.1.4 )\u200b<\/li>\n<\/ul>\n\n\n\n

                  Future improvements:<\/strong>\u200b<\/p>\n\n\n\n

                    \n
                  • Machined prototyping \u200b<\/li>\n\n\n\n
                  • Anatomical validation testing\u200b<\/li>\n\n\n\n
                  • Clinical Research \u200b<\/li>\n<\/ul>\n\n\n\n

                    <\/p>\n\n\n\n

                    Acknowledgments<\/h2>\n\n\n\n
                      \n
                    • Greg Gdowski (Executive Director of CMTI)<\/li>\n\n\n\n
                    • Marty Gira (Senior Research Engineer<\/li>\n\n\n\n
                    • Amy Lerner (Professor of Biomedical Engineering)<\/li>\n\n\n\n
                    • Dr. Sandeep Soin (Orthopedic Surgeon)<\/li>\n\n\n\n
                    • Dr. David Mitten (Orthopedic Surgeon, Business Coach)
                      <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

                      Meet the Team Background Wedge Deformities: Also known as the Wedge Effect. Characterized by the distraction of the proximal femur and lateralization of medullary nails within the femur. \u200b \u200b Why is it…<\/p>\n","protected":false},"author":6242,"featured_media":146132,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[86],"tags":[],"coauthors":[8612],"class_list":["post-111302","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmti-archive"],"acf":[],"yoast_head":"\nReStable - Senior Design Day<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hajim.rochester.edu\/senior-design-day\/restable\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ReStable - 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