Pathologic Fracture, Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region, Scoliosis Thoracic Region
Conditions
Keywords
fusion, screw positioning, screw insertion
Brief 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
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
DEVICEMedical 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
Deep Health Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
• 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. Intervention: 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. • Control arm: Standard of care - 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the screw implantation by Gertzbein-Robbins scale | 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 | Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively. | 24 hours after surgery | Mean and STD Values in milli-gray (mGy) and seconds collected from the c-Arm |
| Evaluate time-per-screw for the experimental device arm (PKS) arm. | Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery) | Operative time per screw |
Countries
United Kingdom
Outcome results
None listed