Femoral FractureNCT01300520
The Development of a Surgical Localizing Aid Medical Device
A study testing Target Tape in people with Femoral Fracture and Tibial Fracture, run by Aeos Biomedical Inc. at 1 site in Canada.
Trial summary
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Femoral Fracture, Tibial Fracture
- What is being tested?
- Target Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must be undergoing a radiological imaging, such as planar X-ray, fluoroscopy, CT or MRI
Who cannot join
- Subjects who may have allergies to medical skin adhesives, medical skin inks or copper metal
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of British Columbia Department of Orthopaedics
Vancouver, British Columbia, V5Z1L8
About this study
Official title: The Development of a Surgical Localizing Aid Medical Device and the Determination and Analysis of Significant Variables
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Surgeons commonly use palpation to locate the point of incision. They may feel for the area directly or find landmarks under the skin and estimate the location from there. The following factors further complicate palpation: overweight patients, foreign bodies that are difficult to feel for under the skin, fractures with little displacement, or locations under dense muscles. These difficulties are compounded for new surgeons, since palpation is a skill derived through experience.
In many circumstances the surgeon only needs to know where to insert the tool or place the incision - they do not necessarily need to know the depth of the area of interest. If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the patient to radiation. Many fluoroscopic images may be required in a single procedure.
Read more
By identifying the efficacy of this new medical device, "Target Tape", there is the potential outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and a reduced chance in surgical error and the associated costs.
Target Tape is a non invasive device that is in a grid or ruler format that is placed against the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan. Standard surgical skin ink is then used to place these markings in a defined pattern on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can correlate these skin markings to the medical scan image to make their incisions in more accurate locations.
Read the detailed description
Consent must first be obtained from the prospective patient before Target Tape can be incorporated into the procedure. When a target procedure is scheduled to occur, the surgeon will first determine if Target Tape would be appropriate to use. The procedure will need to be able to integrate Target Tape into it using the Method of Use described above. The decision to then pursue the procedure will be under the discretion of the medical practitioner and consent from the patient. Depending on the procedure, the medical practitioner may need to communicate to the OR or the radiology department to integrate Target Tape into their protocol, since the practitioner making the incisions(s) may not always be the one applying it. Examples of procedures that may utilize Target Tape may be stabilization of fractures, interlocking screw insertions during tibia or femur nailings, breast biopsies, foreign body removals, thoracic and spinal surgeries. Once the procedure is determined to be appropriate to accommodate Target Tape, the medical practitioner will approach the prospective patient and explain how the device will be utilized, the benefits and potential risks associated with it, and answer any questions the patient may have. A representative from Aeos Biomedical may be on hand to aid with this process and may also observe said procedure to record the necessary information. The consent form will then be signed and Target Tape will then be utilized during the procedure.
The methodology of creating an outcome measure will occur over 2 stages with multiple steps in each stage:
Stage I: Proof of Concept
- Specify measurement goals
- Proof of Concept Testing
- Item generation
- Item reduction
Stage 2: Verification 5. Verification Testing 6. Reliability 7. Validity 8. Interpretability
(i) Subjects (ii) Involved Groups (iii) Data Collection (iv) Statistics
- Statistical Analysis Sample size
Stage 1:
3 Orthopaedic surgeons, up to 10 patients, per procedure type
3 Spinal surgeons up to 10 patients, per procedure type
3 Plastic surgeons up to 10 patients, per procedure type
2 Thoracic surgeons up to 5 patients, per procedure type
2 Radiologists up to 10 patients, per procedure type
The number of medical practitioners in each type of procedure may fluctuate. Furthermore, this is not a definitive list of specialties. It is foreseeable that a greater variety of procedures from other specialties may be included in the proof of concept testing. Moreover, the number of patients may vary depending on the relative magnitude of the observations and feedback from the medical practitioners.
Stage 2:
The sample sizes for each segment of this stage corresponds to sample sizes used to create outcome measures in the different populations. After Stage 1 has been completed, the sample sizes for Stage 2 will be assessed and a statistical model will be created at that time. A preliminary estimate would require 5 times the sample size per procedure within Stage 1 to be a sufficient.
Variable generation - There is no statistical analysis at this step. It is anticipated that up to 10 procedures would have used the device with at least two different doctors.
Variable reduction - The list of items generated in the step above will be administered to doctors who will be asked to rate the items according to importance. Any items that are deemed insignificant will be removed from the list.
Verification Testing It is anticipated that 5 times the sample size for each procedure will occur in this step. Subject to the testing results of Stage 1, there will be a set of significant performance variables determined for each respective target procedure. Target Tape would then be randomly utilized in the procedures, with controls for who is performing the procedure and patient characteristics. Observation of the significant performance variable occurs for all the procedures
- Conditions
- Femoral Fracture, Tibial Fracture
- Being tested
- Target Tape
- Keywords
- Fluoroscopy, Femoral fracture, Tibial fracture, Spinal Fusion
- Medical subject headings
- Femoral Fractures, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target TapeDevice
Comparing procedures using Target Tape against procedures not using Target Tape
| Study group | Role | What they receive |
|---|---|---|
| Target Tape | No intervention | Including target tape in the procedure |
| Control | Other | Without target tape in the procedure Receives: Device: Target Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision Length
Measuring the reduction in incision length from using Target Tape
Measured: one year
Secondary outcomes (2)
Reduction in Fluoroscopy Exposure
Measuring the decreased amount of fluoroscopy radiation exposed to the medical staff and the patient.
Measured: one year
Procedure Time Savings
Measuring the time savings of using Target Tape during the procedure.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2013
Why it stopped: Enough surgeon use to validate the usefulness of the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeos Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Blachut, MD, FRCS(C), Principal investigator, The University of British Columbia Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300520
- Sponsor's protocol ID
- TT-1
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2011
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Margarido CB, Mikhael R, Arzola C, Balki M, Carvalho JC. The intercristal line determined by palpation is not a reliable anatomical landmark for neuraxial anesthesia. Can J Anaesth. 2011 Mar;58(3):262-6. doi: 10.1007/s12630-010-9432-z. Epub 2010 Dec 3.
PubMed 21128128Benzel, Edward. Spine Surgery: Techniques, Complication, Avoidance, and Management. 2nd. Philadelphia: Elsevier, 2005. 1521-1528. Print
Gugala, Zbigniew, Arvind Nana, and Ronald Lindsey.
Soar J, Peyton J, Leonard M, Pullyblank AM. Surgical safety checklists. BMJ. 2009 Jan 21;338:b220. doi: 10.1136/bmj.b220. No abstract available.
PubMed 19158173
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Surgical Localizing Aid Medical Device and the Determination and Analysis of Significant Variables
- ClinicalTrials.gov ID
- NCT01300520
- Acronym / sponsor ID
- TT-1
- Conditions
- Femoral Fracture, Tibial Fracture
- Keywords
- Fluoroscopy, Femoral fracture, Tibial fracture, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enough surgeon use to validate the usefulness of the device
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Aeos Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Feb 2011 (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.
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made. However, the precise information of the scan is not shown on the patient's skin. Surgeons commonly use palpation to locate the point of incision. They may feel for the area directly or find landmarks under the skin and estimate the location from there. The following factors further complicate palpation: overweight patients, foreign bodies that are difficult to feel for under the skin, fractures with little displacement, or locations under dense muscles. These difficulties are compounded for new surgeons, since palpation is a skill derived through experience.
In many circumstances the surgeon only needs to know where to insert the tool or place the incision - they do not necessarily need to know the depth of the area of interest. If palpation proves ineffective, they may be forced to use fluoroscopy. By referencing the fluoroscopy image the surgeon moves a radiopaque marker, such as their surgical tool, closer to the area of interest. Fluoroscopy is time-consuming, and exposes medical personnel and the patient to radiation. Many fluoroscopic images may be required in a single procedure.
By identifying the efficacy of this new medical device, "Target Tape", there is the potential outcome of making smaller incisions, faster localization, a reduction in fluoroscopy use and a reduced chance in surgical error and the associated costs.
Target Tape is a non invasive device that is in a grid or ruler format that is placed against the subject's skin. The grid/ruler pattern will then appear on the medical imaging scan. Standard surgical skin ink is then used to place these markings in a defined pattern on the skin. This pattern mimics the Target Tape grid or ruler pattern. The medical practitioner can correlate these skin markings to the medical scan image to make their incisions in more accurate locations.
Detailed description
Consent must first be obtained from the prospective patient before Target Tape can be incorporated into the procedure. When a target procedure is scheduled to occur, the surgeon will first determine if Target Tape would be appropriate to use. The procedure will need to be able to integrate Target Tape into it using the Method of Use described above. The decision to then pursue the procedure will be under the discretion of the medical practitioner and consent from the patient. Depending on the procedure, the medical practitioner may need to communicate to the OR or the radiology department to integrate Target Tape into their protocol, since the practitioner making the incisions(s) may not always be the one applying it. Examples of procedures that may utilize Target Tape may be stabilization of fractures, interlocking screw insertions during tibia or femur nailings, breast biopsies, foreign body removals, thoracic and spinal surgeries. Once the procedure is determined to be appropriate to accommodate Target Tape, the medical practitioner will approach the prospective patient and explain how the device will be utilized, the benefits and potential risks associated with it, and answer any questions the patient may have. A representative from Aeos Biomedical may be on hand to aid with this process and may also observe said procedure to record the necessary information. The consent form will then be signed and Target Tape will then be utilized during the procedure.
The methodology of creating an outcome measure will occur over 2 stages with multiple steps in each stage:
Stage I: Proof of Concept
- Specify measurement goals
- Proof of Concept Testing
- Item generation
- Item reduction
Stage 2: Verification 5. Verification Testing 6. Reliability 7. Validity 8. Interpretability
(i) Subjects (ii) Involved Groups (iii) Data Collection (iv) Statistics
- Statistical Analysis Sample size
Stage 1:
3 Orthopaedic surgeons, up to 10 patients, per procedure type
3 Spinal surgeons up to 10 patients, per procedure type
3 Plastic surgeons up to 10 patients, per procedure type
2 Thoracic surgeons up to 5 patients, per procedure type
2 Radiologists up to 10 patients, per procedure type
The number of medical practitioners in each type of procedure may fluctuate. Furthermore, this is not a definitive list of specialties. It is foreseeable that a greater variety of procedures from other specialties may be included in the proof of concept testing. Moreover, the number of patients may vary depending on the relative magnitude of the observations and feedback from the medical practitioners.
Stage 2:
The sample sizes for each segment of this stage corresponds to sample sizes used to create outcome measures in the different populations. After Stage 1 has been completed, the sample sizes for Stage 2 will be assessed and a statistical model will be created at that time. A preliminary estimate would require 5 times the sample size per procedure within Stage 1 to be a sufficient.
Variable generation - There is no statistical analysis at this step. It is anticipated that up to 10 procedures would have used the device with at least two different doctors.
Variable reduction - The list of items generated in the step above will be administered to doctors who will be asked to rate the items according to importance. Any items that are deemed insignificant will be removed from the list.
Verification Testing It is anticipated that 5 times the sample size for each procedure will occur in this step. Subject to the testing results of Stage 1, there will be a set of significant performance variables determined for each respective target procedure. Target Tape would then be randomly utilized in the procedures, with controls for who is performing the procedure and patient characteristics. Observation of the significant performance variable occurs for all the procedures
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target Tape | No intervention | –Including target tape in the procedure |
| Control | Other | Device: Target TapeWithout target tape in the procedure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject must be undergoing a radiological imaging, such as planar X-ray, fluoroscopy, CT or MRI
Key exclusion criteria (1 listed)
- Subjects who may have allergies to medical skin adhesives, medical skin inks or copper metal
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 |
|---|---|---|
| Target TapeComparing procedures using Target Tape against procedures not using Target Tape | Device | Control |
Primary outcome
Incision Length
Time frame: one year
Measuring the reduction in incision length from using Target Tape
2 secondary outcomes
Reduction in Fluoroscopy Exposure
Time frame: one year
Procedure Time Savings
Time frame: One Year
Results and safety
The study was stopped early (reason given: Enough surgeon use to validate the usefulness of the device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 21128128Margarido CB, Mikhael R, Arzola C, Balki M, Carvalho JC. The intercristal line determined by palpation is not a reliable anatomical landmark for neuraxial anesthesia. Can J Anaesth. 2011 Mar;58(3):262-6. doi: 10.1007/s12630-010-9432-z. Epub 2010 Dec 3.
- BackgroundBenzel, Edward. Spine Surgery: Techniques, Complication, Avoidance, and Management. 2nd. Philadelphia: Elsevier, 2005. 1521-1528. Print
- BackgroundGugala, Zbigniew, Arvind Nana, and Ronald Lindsey.
- Background: PubMed 19158173Soar J, Peyton J, Leonard M, Pullyblank AM. Surgical safety checklists. BMJ. 2009 Jan 21;338:b220. doi: 10.1136/bmj.b220. No abstract available.
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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.
Piotr Blachut, MD, FRCS(C) principal investigator
The University of British Columbia Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target Tape in people with Femoral Fracture and Tibial Fracture, run by Aeos Biomedical Inc. at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 7 Feb 2017. 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 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?
The study was stopped early (reason given: Enough surgeon use to validate the usefulness of the device). Results are not available in the source record.
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?
Incision Length (time frame: one year). 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 NCT01300520, which also lists 4 linked publications.
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 7 Feb 2017.