Femoral Shaft FractureSureshotNCT01327508

TRIGEN SURESHOT™ Distal Targeting System Study

A study testing TRIGEN SURESHOT Distal Targeting Instrumentation. and Free-hand technique in people with Femoral Shaft Fracture, run by Smith & Nephew, Inc. at 7 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Femoral Shaft Fracture
What is being tested?: TRIGEN SURESHOT Distal Targeting Instrumentation. and Free-hand technique
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 7 sitesin 2 countries
Study dates: Apr 2011to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

University of Maryland Medical Center
Baltimore, Maryland, 21201
Duke University Medical Center
Durham, North Carolina, 27707
Department of Orthopaedics and Rehabilitation
Gainesville, Florida, 32607
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
UC Davis Medical Center
Sacramento, California, 95817
University Hospital Trauma Service
San Antonio, Texas, 78229

Other trials in United States

Canada1 site

Capital District Health Authority
Halifax, Nova Scotia

Other trials in Canada

About this study

Official title: A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation

Read the 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.

Conditions: Femoral Shaft Fracture
Being tested: TRIGEN SURESHOT Distal Targeting Instrumentation., Free-hand technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRIGEN SURESHOT Distal Targeting Instrumentation.Device
Also called SURESHOT
image-guided localization system
Free-hand techniqueOther
Free-hand technique utilizes x-rays to find screw holes.

Study groups in NCT01327508
Study group	Role	What they receive
TRIGEN SURESHOT Distal Targeting	Experimental	TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes. Receives: Device: TRIGEN SURESHOT Distal Targeting Instrumentation.
Standard Nailing Instrumentation.	Active comparator	Free-hand technique utilizes x-rays to find screw holes Receives: Other: Free-hand technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiation Exposure Measurement
Radiation exposure measured in two ways:
Whole body badge TLD ring badge
Measured: Intraoperative

Secondary outcomes (1)

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.
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jun 2013

First posted1 Apr 2011 (estimated)
Study startApr 2011
Primary completionJan 2013
Study completionJun 2013

Why it stopped: Primary endpoint voided. Dosimeters did not capture radiation dose as expected.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Femoral Shaft FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327508
Sponsor's protocol ID: 09-TRI-01
Acronym: Sureshot
Status last verified: Feb 2018
First submitted: 30 Mar 2011
Last updated: 14 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Rehabilitation After Lower Extremity Nailing Trial
Femoral Shaft Fracture, Tibial Shaft Fractures
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
Not yet recruiting
Feasibility of Structured Resistance Training After Lower Extremity Fracture
Lower Extremity Fractures
Recruiting
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Femoral Fracture
Recruiting
Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia Fractures

All Femoral Shaft Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-center, Randomized, Comparison Study of the TRIGEN SURESHOT™ Distal Targeting vs. Standard Targeting Instrumentation
ClinicalTrials.gov ID: NCT01327508
Acronym / sponsor ID: Sureshot / 09-TRI-01
Conditions: Femoral Shaft Fracture
Study type: Interventional
Recruitment status: TerminatedReason stopped: Primary endpoint voided. Dosimeters did not capture radiation dose as expected.
Enrolment: 60 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Jan 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 1 Apr 2011 (estimated)
Results: Posted 9 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TRIGEN SURESHOT Distal Targeting	Experimental	Device: TRIGEN SURESHOT Distal Targeting Instrumentation.TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.
Standard Nailing Instrumentation.	Active comparator	Other: Free-hand techniqueFree-hand technique utilizes x-rays to find screw holes

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRIGEN SURESHOT Distal Targeting Instrumentation.Also: SURESHOTimage-guided localization system	Device	TRIGEN SURESHOT Distal Targeting
Free-hand techniqueFree-hand technique utilizes x-rays to find screw holes.	Other	Standard Nailing Instrumentation.

Primary outcome

Radiation Exposure Measurement
Time frame: Intraoperative
Radiation exposure measured in two ways: Whole body badge TLD ring badge

1 secondary outcome

Distal Locking Time
Time frame: Intraoperative

Results and safety

Results posted to the registry on 9 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRIGEN SURESHOT Distal Targeting	30	30
Standard Nailing Instrumentation.	30	30

Primary outcome: Radiation Exposure Measurement

Time frame: Intraoperative

Population analysed: Primary endpoint voided. Dosimeters did not capture radiation dose as expected.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Operative and immediate postoperative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRIGEN SURESHOT Distal Targeting	0 of 30 (0%)	4 of 30 (13.3%)	Not reported
Standard Nailing Instrumentation.	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Femoral Shaft Fracture

Not yet recruiting
Rehabilitation After Lower Extremity Nailing Trial
Femoral Shaft Fracture, Tibial Shaft Fractures
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
Not yet recruiting
Feasibility of Structured Resistance Training After Lower Extremity Fracture
Lower Extremity Fractures
Recruiting
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Femoral Fracture
Recruiting
Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samir Mehta, M.D. principal investigator

Orthopaedic Surgery, Hospital of the University of Pennsylvania

Animesh Agarwal, M.D. principal investigator

UT Health Science Center, Dept of Orthopaedic

Marcus Sciadini, M.D principal investigator

University of Maryland Baltimore, Department of Orthopaedics

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TRIGEN SURESHOT Distal Targeting Instrumentation. and Free-hand technique in people with Femoral Shaft Fracture, run by Smith & Nephew, Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiation Exposure Measurement (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.