Tibial FracturesSure ShotNCT01183078
Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients
A study testing free-hand and Wand technique in people with Tibial Fractures and Femoral Fractures, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures, Femoral Fractures
- What is being tested?
- free-hand and Wand technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older with tibial or femoral fracture suitable for operative repair with intramedullary nailing.
Who cannot join
- Fractures requiring repair by retrograde intramedullary nails and interlocking nails.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences - CompRehab
Winston-Salem, North Carolina, 27157
About this study
Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. The purpose of this research study is to compare the efficacy of distal locking of intramedullary nails using a standard free-hand technique with the guided wand technique. Distal locking is the placement of screws through the intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays in order to find the holes in the intramedullary rod to place the screws. The wand technique uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of the wand technique could result in improvements in drill placement and locking nail placement as well as decrease operative time and radiation exposure.
Read the detailed description
Methods and Measures Patients 18 years of age and older presenting through the emergency room at Wake Forest University Baptist Medical Center with tibial and femoral fractures suitable for operative repair will be prospectively enrolled. Inclusion criteria will include any patient with a tibia fracture or femur fracture requiring intramedullary nailing. Retrograde intramedullary nails will be excluded as will nails which are not interlocked. The goal for enrollment is 24 tibial and 24 femoral fractures. Data including operative time, C-arm time, and "nail misses" will be obtained in the operating room for 24 tibial and 24 femoral nails. Surgeons who perform the procedure will have had experience using the freehand technique and will be trained with the guided wand prior to the experiment. Locking will be performed with the freehand and the wand technique in alternating order for the two interlocking screws. The order of which technique is utilized first will be randomly assigned. All procedures will be timed, and fluoroscopy time, radiation time, and any "nail misses" will be documented. All tibial nails will be locked with 2 mediolateral screws and all femurs with 2 lateral to medial screws.
Patients will receive follow-up for complications for a 6 month period after surgical procedure. Intervals of follow-up will be at 2 weeks, 6 weeks, 3 months and 6 months. Anterior-posterior and lateral images will be performed as are already customary and usual at these time intervals.
Outcome Measure(s) The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduced operative time, C-arm exposure and inadvertent "nail misses." Additionally, it is expected that there will exist no complications related to the use of this technique.
- Conditions
- Tibial Fractures, Femoral Fractures
- Being tested
- free-hand, Wand technique
- Keywords
- efficacy, drill placement, nail placement, radiation, Operative time, Reduction in exposure to radiation, Accuracy for nail placement
- Medical subject headings
- Tibial Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free-handProcedure or surgery
Free-hand technique utilizes x-rays to find screw holes.
Wand techniqueProcedure or surgery
Wand technique is utilized to find screw holes.
| Study group | Role | What they receive |
|---|---|---|
| Free-hand technique | Other | Free-hand technique utilized to find screw holes. Receives: Procedure: free-hand |
| Wand technique | Other | Wand technique is utilized to find screw holes. Receives: Procedure: Wand technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced operative time.
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.
Measured: Six months post surgery
Reduced C-arm exposure
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.
Measured: Six months post surgery
Reduces inadvertent nail misses.
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."
Measured: Six months post surgery
No complications
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement. It is expected that there will exist no complications related to the use of this technique.
Measured: Six months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Riyaz H. Jinnah, MD, FRCS, Principal investigator, Wake Forest University Health SciencesEben A. Carroll, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183078
- Sponsor's protocol ID
- IRB00012034
- Acronym
- Sure Shot
- Status last verified
- Jul 2018
- First submitted
- 11 Aug 2010
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Locking Using an Electromagnetic Field Guided Computer Based Real Time System for Orthopaedic Trauma Patients
- ClinicalTrials.gov ID
- NCT01183078
- Acronym / sponsor ID
- Sure Shot / IRB00012034
- Conditions
- Tibial Fractures, Femoral Fractures
- Keywords
- efficacy, drill placement, nail placement, radiation, Operative time, Reduction in exposure to radiation, Accuracy for nail placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Aug 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Utilization of the "wand" method will enhance improvements in drill placement, locking nail placement during tibia and femur fracture repairs, and offer less radiation exposure and less operative time. The purpose of this research study is to compare the efficacy of distal locking of intramedullary nails using a standard free-hand technique with the guided wand technique. Distal locking is the placement of screws through the intramedullary rod to hold it in place and prevent rotation. Currently, the free-hand technique is most often utilized. With this technique, the surgeon uses intraoperative x-rays in order to find the holes in the intramedullary rod to place the screws. The wand technique uses electromagnetic fields rather than x-rays to find these screw holes. The utilization of the wand technique could result in improvements in drill placement and locking nail placement as well as decrease operative time and radiation exposure.
Detailed description
Methods and Measures Patients 18 years of age and older presenting through the emergency room at Wake Forest University Baptist Medical Center with tibial and femoral fractures suitable for operative repair will be prospectively enrolled. Inclusion criteria will include any patient with a tibia fracture or femur fracture requiring intramedullary nailing. Retrograde intramedullary nails will be excluded as will nails which are not interlocked. The goal for enrollment is 24 tibial and 24 femoral fractures. Data including operative time, C-arm time, and "nail misses" will be obtained in the operating room for 24 tibial and 24 femoral nails. Surgeons who perform the procedure will have had experience using the freehand technique and will be trained with the guided wand prior to the experiment. Locking will be performed with the freehand and the wand technique in alternating order for the two interlocking screws. The order of which technique is utilized first will be randomly assigned. All procedures will be timed, and fluoroscopy time, radiation time, and any "nail misses" will be documented. All tibial nails will be locked with 2 mediolateral screws and all femurs with 2 lateral to medial screws.
Patients will receive follow-up for complications for a 6 month period after surgical procedure. Intervals of follow-up will be at 2 weeks, 6 weeks, 3 months and 6 months. Anterior-posterior and lateral images will be performed as are already customary and usual at these time intervals.
Outcome Measure(s) The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduced operative time, C-arm exposure and inadvertent "nail misses." Additionally, it is expected that there will exist no complications related to the use of this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free-hand technique | Other | Procedure: free-handFree-hand technique utilized to find screw holes. |
| Wand technique | Other | Procedure: Wand techniqueWand technique is utilized to find screw holes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and older with tibial or femoral fracture suitable for operative repair with intramedullary nailing.
Key exclusion criteria (1 listed)
- Fractures requiring repair by retrograde intramedullary nails and interlocking nails.
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 |
|---|---|---|
| free-handFree-hand technique utilizes x-rays to find screw holes. | Procedure or surgery | Free-hand technique |
| Wand techniqueWand technique is utilized to find screw holes. | Procedure or surgery | Wand technique |
Primary outcome
Reduced operative time.
Time frame: Six months post surgery
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement which reduces operative time.
Reduced C-arm exposure
Time frame: Six months post surgery
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces C-arm exposure.
Reduces inadvertent nail misses.
Time frame: Six months post surgery
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement, which reduces inadvertent "nail misses."
No complications
Time frame: Six months post surgery
The goal is to prospectively assess the "wand" technique as a reliable alternative to standard interlocking screw placement. It is expected that there will exist no complications related to the use of this technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Riyaz H. Jinnah, MD, FRCS principal investigator
Wake Forest University Health Sciences
Eben A. Carroll, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free-hand and Wand technique in people with Tibial Fractures and Femoral Fractures, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduced operative time. (time frame: Six months post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.