Using big data to predict outcomes in spine surgery
Official title: Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
Run by Sahlgrenska University Hospital · NCT05817747 · Data updated 2026-11-12
This study is testing a digital tool that predicts recovery outcomes to see if it helps people feel better and more satisfied after spine surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 10 sites (Ängelholm, Skåne County and 9 other locations) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2029 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT05817747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are referred for surgery due to lumbar spinal stenosis or cervical radiculopathy and have a recent MRI confirming their diagnosis.
✕Probably not a fit
Patients with alternative conditions causing their symptoms or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a digital prediction tool called the Dialogue Support tool in improving postoperative outcomes and patient satisfaction for individuals undergoing spine surgery. It will assess whether providing patients with predicted outcomes can enhance their reported experiences regarding leg and arm pain, as well as overall satisfaction. The study will also compare the quality of life between patients who undergo surgery and those who do not, despite having similar baseline profiles. The trial is multicenter and prospective, involving multiple clinics.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient satisfaction and better-informed decision-making regarding spine surgery.
How similar studies have gone: While the use of predictive tools in clinical settings is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar contexts.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy * 18 years of age or older * Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician * Giving informed consent Exclusion Criteria: * Another condition found to be the reason for the symptoms. * Not giving informed consent * Need for further investigation that prevents inclusion within one month of the doctor visit.
Where it's running
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Aleris Ortopedi Ängelholm
Ängelholm, Skåne County, Sweden Recruiting -
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden Recruiting -
Spine Center Göteborg
Gothenburg, Västra Götaland County, Sweden Recruiting -
Ryggkirurgiskt Centrum
Stockholm, Sweden Recruiting -
Spine Center Stockholm
Stockholm, Sweden Recruiting -
Sundsvalls sjukhus
Sundsvall, Sweden Recruiting
Show 4 more locations
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Norrland University Hospital
Umeå, Sweden Recruiting -
Uppsala University Hospital
Uppsala, Sweden Recruiting -
Aleris Ortopedi Malmö
Malmö, Skåne County, Sweden Active not recruiting -
Aleris Elisabethsjukhuset
Uppsala, Sweden Active not recruiting
Study contacts
- Principal investigator: Catharina Parai, MD, PhD — Sahlgrenska University Hospital
- Study coordinator: Catharina Parai, MD, PhD
- Email: catharina.parai@vgregion.se
- Phone: 0046313421000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.