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

NCT06554093 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-05

No results posted yet for this study

Summary

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

Conditions

  • Scoliosis
  • Scoliosis; Adolescence
  • Scoliosis Kyphosis
  • Scoliosis Lumbar Region
  • Scoliosis Thoracic Region
  • Pathologic Fracture

Interventions

DEVICE

Medical Device - PKS

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.

Sponsors & Collaborators

  • Deep Health Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554093 on ClinicalTrials.gov