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

ConditionsScoliosis Scoliosis; Adolescence Scoliosis Kyphosis Scoliosis Lumbar Region Scoliosis Thoracic Region Pathologic 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

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

Treatments tested in this trial

Medical Device - PKS

Treatment groups

32 Participants

are divided into 2 treatment groups

Locations

Leeds HospitalLS9 7TF, LeedsWest Yorkshire, United Kingdom

Sponsors and collaborators

Deep Health Ltd.

Lead sponsor

Source ClinicalTrials.gov