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Senior Design Day

ReStable

ReStable

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. ​

​

Why is it a Problem?​

  • Fracture becomes fixed in varus reduction​
  • Changes biomechanical fixation parameters​
  • Leads to implant failure or revision surgery

Clinical Scenario

How Does it Happen?​

  • Region of dense bone in superolateral femoral neck deflects path of reamer​
  • Only visible upon full insertion of medullary nail, surgeon must repeat reaming step

Gaps in Current Solutions:​

  • Increased physiological burden​
  • May require an assistant to manually hold instruments​
  • Solutions are implemented only after the problem occurs

Market Opportunity​

  • Total addressable market: $6.4 billion global hip fracture treatment
  • Serviceable available market: $2.52 billion in spent on costs associated with hip fracture treatment with IMN
  • Serviceable obtainable market: $9.3 million (1800 devices and 150,000 disposables)

The Solution

The WedgeWise Clamp: An orthopedic clamp for reducing fragments of the proximal femur during IM reaming​

Components:​

A: Stainless Steel Head Piece​

B: Stainless Steel Nut​

C: Polyethylene Body​

D: Polyethylene Handle

How it Works:​

  • Tightened into place around tip of trochanter ​
  • Body component extracted​
  • Handle and body removed from surgical site​
  • Cannulation allows reaming to take place unobstructed 

Advantages:​

  • No additional incisions  ​
  • Does not require an assistants help ​
  • Designed to prevent wedge deformities from occurring in the first place   

Proof of Concept Testing

Comparing Clamping Forces: Placing a calibrated pressure sensor in the wedged bone fracture and taking repetitive​ measurements for the different clamping methods. ​
Results: Significant difference between clamping ​ and no clamping ​ Non-significant difference between metal clamp ​ and our prototype

Comparing Wedge Size Detection: Placing a calibrated pressure sensor with known reference values to wedge size and taking repetitive measurements for the different clamping methods ​ ​
Results: Significant difference between clamping and no clamping for P ≤ 0.0001 ​. Significant difference between the metal clamp and prototype for P ≤ 0.05 ​

Next Steps

Regulatory Pathway: ​

  • Class II Device – CFR 878.4800, product code -HXD​
  • 510(k) Pathway​

Testing:​

  • FDA required testing following the Standard Specification and Test Methods for External Skeletal Fixation Devices, cortex clamp ( ASTM F 1541,  6.1.4 )​

Future improvements:​

  • Machined prototyping ​
  • Anatomical validation testing​
  • Clinical Research ​

Acknowledgments

  • Greg Gdowski (Executive Director of CMTI)
  • Marty Gira (Senior Research Engineer
  • Amy Lerner (Professor of Biomedical Engineering)
  • Dr. Sandeep Soin (Orthopedic Surgeon)
  • Dr. David Mitten (Orthopedic Surgeon, Business Coach)