Intervertebral Disc DisplacementNCT06806969
Artificial Intelligence Enabled Decision Support for Selection of Patients for Lumbar Spine Surgery
A study testing Decision support in people with Intervertebral Disc Displacement and Spinal Stenosis Lumbar, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intervertebral Disc Displacement, Spinal Stenosis Lumbar, Lumbar Disc Herniation
- What is being tested?
- Decision support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with MRI-confirmed LDH or LSS referred to University hospital of North Norway Tromsø for assessment of indication for surgery
- Specialists and physicians in training (for two years or more) in neurosurgery or orthopedic surgery who evaluate such patients at the neurosurgical outpatient clinic at University hospital of North Norway Tromsø
Who cannot join
- Patients unable to consent because of
- Age < 18 years
- Serious drug abuse of severe psychiatric disorders
- Language barriers (patients who cannot speak or read Norwegian)
- Patients with a baseline ODI ≤14 (LDH) or ≤22 (LSS)
- Patients undergoing non-elective/emergency operations
- Patients with degenerative conditions other that LDH and LSS, fractures, primary infections, or malignant conditions of the spine
- Physicians in training with less than two years' experience with spine surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
University Hospital of North Norway
Tromsø, Troms, 9010
Tor Ingebrigtsen, Professor and consultant neurosurgeon, +47 911 99843, tor.ingebrigtsen@unn.no
About this study
Official title: Artificial Intelligence (AI) Enabled Decision Support Tool for Selection of Patients for Lumbar Spine Surgery: a Feasibility Study
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice.
The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®.
Read more
The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study.
The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case ("patients-like-me"). Finally, the individual prediction and the outcomes for the "patients-like-me" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM.
Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.
- Conditions
- Intervertebral Disc Displacement, Spinal Stenosis Lumbar, Lumbar Disc Herniation, Lumbar Spine Degeneration
- Being tested
- Decision support
- Keywords
- artificial intelligence, decision support, surgery selection
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision supportDevice
Patients will digitally fill out forms, which will go into the decision support tool integrated in the electronic health record journal, which predicts outcome of surgery for the patient, to inform shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| Decision support | Experimental | Patients and surgeons. Patients with lumbar disc herniation or lumbar spinal stenosis who will receive a digital form regarding patient-related outcome measures in advance of outpatient clinic, and will experience the use of the decision support in the consultation with the spine surgeon. Spine surgeons who will use the decision support in outpatient clinic to decide whether to perform spinal surgery. Receives: Device: Decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeons' acceptability
Surgeons' acceptability of the decision support for a following clinical pilot study (yes/no)
Measured: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Patients' acceptability
Patients' acceptability of the decision support for a clinical pilot study (yes/no)
Measured: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Secondary outcomes (3)
Surgeons' compliance rate
The proportion of consultations in which the surgeon uses the decision support as intended
Measured: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Patients' compliance rate
The proportion of patients who complete the online questionnaire with the required information before the outpatient clinic visit
Measured: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Time
Duration of the consultation (minutes)
Measured: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisplacementStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of software (medical device integrated in electronic health record) and following changed workflow in outpatient clinic (20 patient, 6 surgeons)
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806969
- Sponsor's protocol ID
- CIV-NO-24-06-047736
- Other IDs
- CIV-NO-24-06-047736
- Status last verified
- Nov 2024
- First submitted
- 14 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data privacy concerns, individual data from interviews will not be available to others in other forms than the refined analyses and descriptions in open-access publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence (AI) Enabled Decision Support Tool for Selection of Patients for Lumbar Spine Surgery: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06806969
- Acronym / sponsor ID
- CIV-NO-24-06-047736
- Conditions
- Intervertebral Disc Displacement, Spinal Stenosis Lumbar, Lumbar Disc Herniation, Lumbar Spine Degeneration
- Keywords
- artificial intelligence, decision support, surgery selection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Feb 2025 (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.
Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice.
The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®.
The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study.
The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case ("patients-like-me"). Finally, the individual prediction and the outcomes for the "patients-like-me" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM.
Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of software (medical device integrated in electronic health record) and following changed workflow in outpatient clinic (20 patient, 6 surgeons)
| Arm | Type | Receives |
|---|---|---|
| Decision support | Experimental | Device: Decision supportPatients and surgeons. Patients with lumbar disc herniation or lumbar spinal stenosis who will receive a digital form regarding patient-related outcome measures in advance of outpatient clinic, and will experience the use of the decision support in the consultation with the spine surgeon. Spine surgeons who will use the decision support in outpatient clinic to decide whether to perform spinal surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with MRI-confirmed LDH or LSS referred to University hospital of North Norway Tromsø for assessment of indication for surgery
- Specialists and physicians in training (for two years or more) in neurosurgery or orthopedic surgery who evaluate such patients at the neurosurgical outpatient clinic at University hospital of North Norway Tromsø
Key exclusion criteria (8 listed)
- Patients unable to consent because of
- Patients with a baseline ODI ≤14 (LDH) or ≤22 (LSS)
- Patients undergoing non-elective/emergency operations
- Patients with degenerative conditions other that LDH and LSS, fractures, primary infections, or malignant conditions of the spine
- Physicians in training with less than two years' experience with spine surgery
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 |
|---|---|---|
| Decision supportPatients will digitally fill out forms, which will go into the decision support tool integrated in the electronic health record journal, which predicts outcome of surgery for the patient, to inform shared decision making. | Device | Decision support |
Primary outcome
Surgeons' acceptability
Time frame: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Surgeons' acceptability of the decision support for a following clinical pilot study (yes/no)
Patients' acceptability
Time frame: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.
Patients' acceptability of the decision support for a clinical pilot study (yes/no)
3 secondary outcomes
Surgeons' compliance rate
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Patients' compliance rate
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Time
Time frame: The rates and the duration will be calculated as averages for the study period, and towards the end of the study, after iterative redesign according to requirements identified with the qualitative methods at up to 70 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No. Due to data privacy concerns, individual data from interviews will not be available to others in other forms than the refined analyses and descriptions in open-access publications.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision support in people with Intervertebral Disc Displacement and Spinal Stenosis Lumbar, run by University Hospital of North Norway at 1 site in Norway.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tor Ingebrigtsen, Professor and consultant neurosurgeon (+47 911 99843, tor.ingebrigtsen@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeons' acceptability (time frame: Acceptability will be assessed continuously, but finally evaluated towards the end of the study, after iterative redesign of the DST and the related workflow according to requirements identified with qualitative methods at up to 70 weeks.). The study lists 2 primary outcomes in all. 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 4 Feb 2025.