An interventional study of Medical Device - PKS in Scoliosis, Scoliosis; Adolescence and Scoliosis Kyphosis, sponsored by Deep Health Ltd.. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Deep Health Ltd. · Not applicable, Interventional, and Treatment
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.
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:
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 32 is below the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Deep Health Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Medical Device - PKS
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
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.
Also known as: Device- Fluoroscopy
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
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
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
Time frame: 24 hours after surgery
Evaluate time-per-screw for the experimental device arm (PKS) arm.
Operative time per screw
Time frame: Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)
Plan to share: No — To be done
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Oct 2025, 0 months later.
Of 233 interventional studies with no phase under Scoliosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Deep Health Ltd.