Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? (PEDI-PDS)

Rennes University Hospital

Status: Unknown

Conditions: Fracture Fixation, Internal

Treatments: Procedure: Spinal osteosynthesis with classical pedicle finder; Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry

Study type: Interventional

Funder types: Other

Identifiers

NCT03238521

35RC16_9855_PEDI-PDS

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

classical pedicle finder

Active Comparator group

Description:

Spinal osteosynthesis with classical pedicle finder

Treatment:

Procedure: Spinal osteosynthesis with classical pedicle finder

pedicle finder with impedancemetry

Experimental group

Description:

Spinal osteosynthesis with pedicle finder with impedancemetry

Treatment:

Procedure: Spinal osteosynthesis with pedicle finder with impedancemetry