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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. â€‹

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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 â€‹
• Body component extracted​
• Handle and body removed from surgical site​
• Cannulation allows reaming to take place unobstructed 

Advantages:​

• No additional incisions  â€‹
• Does not require an assistants help â€‹
• 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: â€‹

• 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 â€‹
• Anatomical validation testing​
• Clinical Research â€‹

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)