Clinical trial NCT01327508: TRIGEN SURESHOT™ Distal Targeting System Study
Official title: A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Shaft Fracture
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Radiation Exposure Measurement
timeFrame: Intraoperative
Secondary outcomes:
measure: Distal Locking Time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Gainesville
country: United States
facility: Department of Orthopaedics and Rehabilitation
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: University Hospital Trauma Service
state: Texas
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
Study officials:
affiliation: Orthopaedic Surgery, Hospital of the University of Pennsylvania
name: Samir Mehta, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Health Science Center, Dept of Orthopaedic
name: Animesh Agarwal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Baltimore, Department of Orthopaedics
name: Marcus Sciadini, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center of Orthopaedic
name: Steven Olson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Chad Coles, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Orthopaedics & Rehab University of Florida
name: Richard Vlasak, M.D.
role: PRINCIPAL_INVESTIGATOR
References: