Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Device - PKS.
- Who it may be relevant to
- Registry conditions: Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Dual Canter, Double Armed, Open Label, Clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in Spine Surgery
Overview
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
Detailed description
Trial design
* Allocation: Randomized * Interventional Model: Parallel Assignment (double armed) * Interventional Model Description: Dual center, prospective, randomized cohort study. * Masking: None (Open Label) * Primary Purpose: Treatment * Enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out).
Study arms
1. Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.
Interventions: Medical Devise - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. 2. Control arm: free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.
Interventions: Pedicle screws will be placed using the free-hand technique with 2D fluoroscopy as the intraoperative imaging modality.
Primary endpoints:
Evaluate and classify the pedicle screw positions as per the Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan, in each study arm and comparatively.
Number of misaligned screws as per the Gertzbein-Robbins classification scale (Gertzbein and Robbins, 1990) class E screws class D screws class C screws class B screws class A screws
Secondary endpoints:
1. Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively. 2. Evaluate time-per-screw for the experimental device arm (PKS) arm. 3. Length of stay - (non-critical) 4. Estimated blood loss (EBL) - (non-critical) 5. Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
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.
Primary outcome measures
- Accuracy of the screw implantation by Gertzbein-Robbins scale [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 outcome measures (2)
- Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively. [Time frame: 24 hours after surgery]
- Evaluate time-per-screw for the experimental device arm (PKS) arm. [Time frame: Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)]
Eligibility criteria
Inclusion criteria
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Exclusion criteria
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Leeds Hospital — Leeds
Identifiers
NCT: NCT06554093 · CL0003 · 341268