Health TrialsbyHealthPanel

Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care

ConditionsScoliosisScoliosis; AdolescenceScoliosis KyphosisScoliosis Lumbar RegionScoliosis Thoracic RegionPathologic Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorDeep Health Ltd.

About this trial

The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question\[s\]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women

16 and above years old

Patients who are about to undergo open, instrumented spinal surgery

Signed informed consent form

Disqualifiers

Men and women

16 and above years old

Patients who are about to undergo open, instrumented spinal surgery

Signed informed consent form

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical Device - PKS

    Device

    The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Medical Device- PathKeeper System (PKS)Experimental treatment 1 intervention
Group B: 2D FluoroscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of the screw implantation by Gertzbein-Robbins scale

Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan

Time frame
Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection

Secondary outcomes

1

Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.

Mean and STD Values in milli-gray (mGy) and seconds collected from the c-Arm

Time frame
24 hours after surgery
2

Evaluate time-per-screw for the experimental device arm (PKS) arm.

Operative time per screw

Time frame
Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deep Health Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: