TRIGEN SURESHOT™ Distal Targeting System Study (Sureshot)

Smith & Nephew

Status

Terminated

Conditions

Femoral Shaft Fracture

Treatments

Other: Free-hand technique

Device: TRIGEN SURESHOT Distal Targeting Instrumentation.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01327508

09-TRI-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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