TRIGEN SURESHOT™ Distal Targeting System Study (Sureshot)
This study has suspended participant recruitment.
(The dosimeters weren't sensitive enough to capture radiation dose of a single case.This voided our primary endpoint.)
Sponsor:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01327508
First received: March 30, 2011
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Femoral Shaft Fracture |
Device: TRIGEN SURESHOT Distal Targeting Instrumentation. Other: Free hand Technique |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation |
Resource links provided by NLM:
Further study details as provided by Smith & Nephew, Inc.:
Primary Outcome Measures:
- radiation exposure measurement [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Distal Locking Time [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TRIGEN SURESHOT Distal Targeting Instrumentation.
TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
|
Device: TRIGEN SURESHOT Distal Targeting Instrumentation.
image-guided localization system
Other Name: SURESHOT
|
|
Active Comparator: Standard Nailing Instrumentation.
Free-hand technique utilizes x-rays to find screw holes
|
Other: Free hand Technique
Free hand technique utilizes x-rays to find screw holes.
|
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 IMN 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 IMN 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Unilateral femoral shaft fracture requiring intramedullary nailing in which the use of sterotactic 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 IMN 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 (Gustillo 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327508
Locations
| United States, California | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| United States, Florida | |
| Department of Orthopaedics and Rehabilitation | |
| Gainesville, Florida, United States, 32607 | |
| United States, Maryland | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27707 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| University Hospital Trauma Service | |
| San Antonio, Texas, United States, 78229 | |
| Canada, Nova Scotia | |
| Capital District Health Authority | |
| Halifax, Nova Scotia, Canada | |
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
| Principal Investigator: | Dr.Medardo R Maroto, M.D. | UT Southwestern Medical Center, Department of Orthopaedic Surgery |
| Principal Investigator: | Dr. Samir Mehta, M.D. | Orthopaedic Surgery, Hospital of the University of Pennsylvania |
| Principal Investigator: | Dr. Animesh Agarwal, M.D. | UT Health Science Center, Dept of Orthopaedic |
| Principal Investigator: | Dr. Marcus Sciadin, M.D | University of Maryland Baltimore, Department of Orthopaedics |
| Principal Investigator: | Dr. Steven Olson, M.D. | Duke University Medical Center of Orthopaedic |
| Principal Investigator: | Dr. Chad Coles, M.D. | Capital District Health Authority, Canada |
| Principal Investigator: | Dr. Richard Vlasak, M.D. | Dept. of Orthopaedics & Rehab University of Florida |
More Information
No publications provided
| Responsible Party: | Smith & Nephew, Inc. |
| ClinicalTrials.gov Identifier: | NCT01327508 History of Changes |
| Other Study ID Numbers: | 09-TRI-01 |
| Study First Received: | March 30, 2011 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Femoral Fractures Fractures, Bone Wounds and Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 21, 2013