ScoliosisPKSforPSPNCT06554093
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
A study testing Medical Device - PKS in people with Scoliosis and Scoliosis; Adolescence, run by Deep Health Ltd. at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis
- What is being tested?
- Medical Device - PKS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Who cannot join
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Hospital
Leeds, West Yorkshire, LS9 7TF
Almas Khan, MD, +44 113 392 8575, almas.khan@nhs.net
Almas Khan, MD
About this study
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
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
Read the 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
- 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:
- Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.
- Evaluate time-per-screw for the experimental device arm (PKS) arm.
- Length of stay - (non-critical)
- Estimated blood loss (EBL) - (non-critical)
- Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region, Scoliosis Thoracic Region, Pathologic Fracture
- Being tested
- Medical Device - PKS
- Keywords
- fusion, screw positioning, screw insertion
- Medical subject headings
- Scoliosis, Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device - PKSDevice
Also called Device- Fluoroscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medical Device - PKS |
| 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 Receives: Device: Medical Device - PKS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (2)
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
Measured: 24 hours after surgery
Evaluate time-per-screw for the experimental device arm (PKS) arm.
Operative time per screw
Measured: Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start30 Oct 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Health Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554093
- Sponsor's protocol ID
- CL0003
- Other IDs
- 341268
- Acronym
- PKSforPSP
- Status last verified
- Aug 2024
- First submitted
- 12 Mar 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be done
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06554093
- Acronym / sponsor ID
- PKSforPSP / CL0003
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region, Scoliosis Thoracic Region, Pathologic Fracture
- Keywords
- fusion, screw positioning, screw insertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Deep Health Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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:
- Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.
- Evaluate time-per-screw for the experimental device arm (PKS) arm.
- Length of stay - (non-critical)
- Estimated blood loss (EBL) - (non-critical)
- Number of reported complications (neurological deficits, dural tears, deep wound infections, etc.) while hospitalized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical Device- PathKeeper System (PKS) | Experimental | Device: Medical Device - PKSOne 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 | Device: Medical Device - PKSControl 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Key exclusion criteria (4 listed)
- Men and women
- 16 and above years old
- Patients who are about to undergo open, instrumented spinal surgery
- Signed informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device - PKSAlso: Device- FluoroscopyThe 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 | 2D Fluoroscopy, Medical Device- PathKeeper System (PKS) |
Primary outcome
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
Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan
2 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No. To be done
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Device - PKS in people with Scoliosis and Scoliosis; Adolescence, run by Deep Health Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.