Spinal DiseasesNCT03015142
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
An observational study of Spinal Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
Trial summary
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- New image-guidance software
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 9 Nov 2016to 8 Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients > 16 years.
Who may be able to join
- Subject undergoing a spine surgery with pedicle screw placement
- Subject 16 years of age or older
- Subject able to give informed consent
Who cannot join
- Subject participating in a potentially confounding device or drug trial during the course of the study.
- Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)
Trial locations and contacts
1 site in 1 country.
About this study
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery.
- Conditions
- Spinal Diseases
- Being tested
- New image-guidance software
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New image-guidance softwareDevice
Patients in this group had spine surgery with new image-guidance software application
| Study group | Role | What they receive |
|---|---|---|
| New image-guidance software | Patients in this group had spine surgery with new image-guidance software application. Receives: Device: New image-guidance software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.
Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm.
Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.
Measured: During surgery, mean 6.71 hours
Secondary outcomes (9)
Procedure Time
Time from skin incision to skin closure
Measured: During surgery, mean 6.71 hours
Time to Insert Pedicle Screw
Measured: Intraoperative, mean 5.18 hours
Length of Hospitalization
Measured: From start of the interventional procedure until hospital discharge, approximately 5.3 days
System Usability Score (SUS Score)
The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).
Measured: End of all surgeries
Patient Radiation Dose
Radiation dose measured in Air Kerma (AK)
Measured: During surgery, mean 6.71 hours
Patient Radiation Dose
Radiation dose measured in Dose Area Product (DAP)
Measured: During surgery, mean 6.71 hours
Radiation Dose (Effective Dose) Received by Operator
Measured: During surgery, mean 6.71 hours
Procedure Related Complications
Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).
Measured: During surgery, mean 6.71 hours
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event
Measured: From start of enrollment until hospital discharge, approximately 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start9 Nov 2016
- Primary completion8 Oct 2017
- Study completion8 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Elmi-Terander, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015142
- Sponsor's protocol ID
- XCY607-130099
- Status last verified
- Mar 2022
- First submitted
- 2 Jan 2017
- Last updated
- 8 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
- ClinicalTrials.gov ID
- NCT03015142
- Acronym / sponsor ID
- XCY607-130099
- Conditions
- Spinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 8 Oct 2017 (actual)
- Study completion
- 8 Oct 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries). The objective of the study was to investigate the accuracy of screw placement during spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New image-guidance software | – | Device: New image-guidance softwarePatients in this group had spine surgery with new image-guidance software application. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients > 16 years.
Key inclusion criteria (3 listed)
- Subject undergoing a spine surgery with pedicle screw placement
- Subject 16 years of age or older
- Subject able to give informed consent
Key exclusion criteria (2 listed)
- Subject participating in a potentially confounding device or drug trial during the course of the study.
- Subject meeting an exclusion criteria according to national law (e.g. pregnant woman, breast feeding woman)
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 |
|---|---|---|
| New image-guidance softwarePatients in this group had spine surgery with new image-guidance software application | Device | New image-guidance software |
Primary outcome
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software
Time frame: During surgery, mean 6.71 hours
Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification. Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm. Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers.
9 secondary outcomes
Procedure Time
Time frame: During surgery, mean 6.71 hours
Time to Insert Pedicle Screw
Time frame: Intraoperative, mean 5.18 hours
Length of Hospitalization
Time frame: From start of the interventional procedure until hospital discharge, approximately 5.3 days
System Usability Score (SUS Score)
Time frame: End of all surgeries
Patient Radiation Dose
Time frame: During surgery, mean 6.71 hours
Patient Radiation Dose
Time frame: During surgery, mean 6.71 hours
Radiation Dose (Effective Dose) Received by Operator
Time frame: During surgery, mean 6.71 hours
Procedure Related Complications
Time frame: During surgery, mean 6.71 hours
Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event
Time frame: From start of enrollment until hospital discharge, approximately 51 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Pedicle Screw Placement Using Augmented Reality Surgical Navigation with Intraoperative 3D Imaging. A First In-Human Prospective Cohort Study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Spinal Diseases
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 4
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)
Spinal Muscular Atrophy
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Not yet recruitingEarly Phase 1
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
Spinal Muscular Atrophy (SMA)
Not yet recruiting
Surface Electromyographic Analysis of Scapular Stabilizer Muscle in Postural Hyperkyphosis
Hyperkyphosis
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.
Adrian Elmi-Terander, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Mar 2022. 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software (time frame: During surgery, mean 6.71 hours). 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 8 Mar 2022.