Fracture Fixation, InternalPEDI-PDSNCT03238521
Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?
A study testing Spinal osteosynthesis with classical pedicle finder and Spinal osteosynthesis with pedicle finder with impedancemetry in people with Fracture Fixation, Internal, run by Rennes University Hospital at 1 site in France.
Trial summary
To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fracture Fixation, Internal
- What is being tested?
- Spinal osteosynthesis with classical pedicle finder and Spinal osteosynthesis with pedicle finder with impedancemetry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2017to 2 Sep 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 80 years-old;
- Patient with an indication of PPTLO for one or two segments
- Patient in a position to understand protocol information;
- Patient who received information about the protocol and who did not show opposition to participate
Who cannot join
- History of posterior spinal fusion surgery on the spinal level concerned by the study;
- Morbid obesity (body mass index greater than 35 kg / m²);
- Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
- Simultaneous participation in another research protocol involving the human person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study
To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.
- Conditions
- Fracture Fixation, Internal
- Being tested
- Spinal osteosynthesis with classical pedicle finder, Spinal osteosynthesis with pedicle finder with impedancemetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal osteosynthesis with classical pedicle finderProcedure or surgery
Posterior thoracic and lumbar osteosynthesis with classical pedicle finder
Spinal osteosynthesis with pedicle finder with impedancemetryProcedure or surgery
Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry
| Study group | Role | What they receive |
|---|---|---|
| classical pedicle finder | Active comparator | Spinal osteosynthesis with classical pedicle finder Receives: Procedure: Spinal osteosynthesis with classical pedicle finder |
| pedicle finder with impedancemetry | Experimental | Spinal osteosynthesis with pedicle finder with impedancemetry Receives: Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose area product in cGy.cm2 (DAP)
Dose area product in cGy.cm2 (DAP)
Measured: Surgery Day
Secondary outcomes (4)
Radiation duration in seconds (measured on the fluoroscope);
Radiation duration in seconds (measured on the fluoroscope);
Measured: Surgery Day
Radiation rate
Radiation rate on:1 ring carried by the surgeon (passive dosimeter),1 passive dosimeter worn at the surgeon's eye level, 1 passive dosimeter on the fluoroscope,1 active dosimeter placed on the bust of the surgeon under the lead apron
Measured: Surgery Day
Path of pedicle screws extracted from fluoroscopic images
Trajectory of pedicle screws;
Measured: Day 2 after surgery
Operating time in minutes.
Operating time in minutes.
Measured: Surgery Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start11 Nov 2017
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Fixation, InternalStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan LEBHAR, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238521
- Sponsor's protocol ID
- 35RC16_9855_PEDI-PDS
- Acronym
- PEDI-PDS
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2017
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03238521
- Acronym / sponsor ID
- PEDI-PDS / 35RC16_9855_PEDI-PDS
- Conditions
- Fracture Fixation, Internal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 3 Aug 2017 (actual)
- 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.
To compare classical pedicle finder versus pedicle finder with impedancemetry on the perioperative radiation exposure of PPTLO. These two devices are already used in common practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical pedicle finder | Active comparator | Procedure: Spinal osteosynthesis with classical pedicle finderSpinal osteosynthesis with classical pedicle finder |
| pedicle finder with impedancemetry | Experimental | Procedure: Spinal osteosynthesis with pedicle finder with impedancemetrySpinal osteosynthesis with pedicle finder with impedancemetry |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between 18 and 80 years-old;
- Patient with an indication of PPTLO for one or two segments
- Patient in a position to understand protocol information;
- Patient who received information about the protocol and who did not show opposition to participate
Key exclusion criteria (4 listed)
- History of posterior spinal fusion surgery on the spinal level concerned by the study;
- Morbid obesity (body mass index greater than 35 kg / m²);
- Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.
- Simultaneous participation in another research protocol involving the human person
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 |
|---|---|---|
| Spinal osteosynthesis with classical pedicle finderPosterior thoracic and lumbar osteosynthesis with classical pedicle finder | Procedure or surgery | classical pedicle finder |
| Spinal osteosynthesis with pedicle finder with impedancemetryPosterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry | Procedure or surgery | pedicle finder with impedancemetry |
Primary outcome
Dose area product in cGy.cm2 (DAP)
Time frame: Surgery Day
Dose area product in cGy.cm2 (DAP)
4 secondary outcomes
Radiation duration in seconds (measured on the fluoroscope);
Time frame: Surgery Day
Radiation rate
Time frame: Surgery Day
Path of pedicle screws extracted from fluoroscopic images
Time frame: Day 2 after surgery
Operating time in minutes.
Time frame: Surgery Day
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 12 Jun 2026.
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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.
Jonathan LEBHAR, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal osteosynthesis with classical pedicle finder and Spinal osteosynthesis with pedicle finder with impedancemetry in people with Fracture Fixation, Internal, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 4 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 12 Jun 2026. 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 France. 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?
Dose area product in cGy.cm2 (DAP) (time frame: Surgery Day). 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 12 Jun 2026.