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| ID | Type | Description | Link |
|---|---|---|---|
| 341268 | Other Identifier | IRAS(Integrated research application system) |
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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
Trial design
Study arms
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Device- PathKeeper System (PKS) | Experimental | 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. |
|
| 2D Fluoroscopy | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours after surgery |
| Evaluate time-per-screw for the experimental device arm (PKS) arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
To be done
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• 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.
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|
Operative time per screw |
| Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery) |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D005598 | Fractures, Spontaneous |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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