TRIGEN SURESHOT™ Distal Targeting System Study

Smith & Nephew, Inc.60 enrolled

Overview

The objective of this study is to quantitate the amount of radiation both subjects and surgeons are exposed to during intramedullary nailing of the femur using the TRIGEN SURESHOT Distal Targeting System versus Standard nailing instrumentation.

The TRIGEN SURESHOT™ Distal Targeting System was designed to be an intraoperative image-guided localization system to aid with drill positioning for screws during intramedullary nailing distal interlocking. It is hypothesized that this system will aid in identification of the distal holes leading to reduced exposure to radiation. The SURESHOT System provides information to the surgeon that is used to place surgical instruments utilizing electromagnetic tracking data obtained intraoperatively. It is indicated for long bone fractures treated with intramedullary nailing in which the use of stereotactic surgery may be appropriate. The hypothesis is that using the TRIGEN SURESHOT™ Distal Targeting System will allow accurate distal locking while effectively decreasing the amount of radiation exposure compared to the standard instrumentation process.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Femoral Shaft Fracture

Interventions

TRIGEN SURESHOT Distal Targeting Instrumentation.DEVICE

image-guided localization system

Free-hand techniqueOTHER

Free-hand technique utilizes x-rays to find screw holes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria * Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of stereotactic surgery may be appropriate. * Subject is between 18-80 years of age. * Subject is skeletally mature * Subject is of legal age and capable of providing legal consent. * Subject is suitable for current Intramedullary Nailing procedure * Subject willing to accept randomization either to the TRIGEN SURESHOT Distal Targeting System or TRIGEN standard instrumentation. Exclusion Criteria * Femur shaft fracture not amenable to intramedullary nailing in which the use of sterotactic surgery may be inappropriate. * Fracture with vascular injury (Gustilo Type IIIC) requiring repair * Open fractures where open wound is in communication with distal targeting holes and therefore would influence duration of locking procedure (i.e. potentially no need for incisions for locking screw placement). * Fracture of the Metaphyseal distal femur with intraarticular comminution * Known Pathological Fracture * Subject is a prisoner * Operative procedure for closed fracture is scheduled for greater than 2 weeks for closed fractures * Subject has cognitive issue/mental status conditions that preclude intramedullary nailing in the judgment of the investigator. * Contralateral femoral shaft fracture

Locations (7)

UC Davis Medical Center

Sacramento, California, United States

Department of Orthopaedics and Rehabilitation

Gainesville, Florida, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Radiation Exposure Measurement

Radiation exposure measured in two ways: Whole body badge TLD ring badge

Time frame: Intraoperative

Secondary Outcomes

Distal Locking Time

Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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