NCT03238521

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

July 25, 2017

Last Update Submit

August 28, 2018

Conditions

Fracture Fixation, Internal

Outcome Measures

Primary Outcomes (1)

  • Dose area product in cGy.cm2 (DAP)

    Dose area product in cGy.cm2 (DAP)

    Surgery Day

Secondary Outcomes (4)

  • Radiation duration in seconds (measured on the fluoroscope);

    Surgery Day

  • Radiation rate

    Surgery Day

  • Path of pedicle screws extracted from fluoroscopic images

    Day 2 after surgery

  • Operating time in minutes.

    Surgery Day

Study Arms (2)

classical pedicle finder

ACTIVE COMPARATOR

Spinal osteosynthesis with classical pedicle finder

Procedure: Spinal osteosynthesis with classical pedicle finder

pedicle finder with impedancemetry

EXPERIMENTAL

Spinal osteosynthesis with pedicle finder with impedancemetry

Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry

Interventions

Spinal osteosynthesis with classical pedicle finderPROCEDURE

Posterior thoracic and lumbar osteosynthesis with classical pedicle finder

classical pedicle finder
Spinal osteosynthesis with pedicle finder with impedancemetryPROCEDURE

Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry

pedicle finder with impedancemetry

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic surgery division

Rennes, 35033, France

RECRUITING

Study Officials

  • Jonathan LEBHAR, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan LEBHAR, MD

CONTACT

299285753Jonathan.LEBHAR@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 3, 2017

Study Start

November 11, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

FR(1)