Using big data to predict outcomes in spine surgery
Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 10 sites (Ängelholm, Skåne County and 9 other locations) |
| Trial ID | NCT05817747 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with alternative conditions causing their symptoms or those unable to provide informed consent may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ängelholm, Skåne County and 9 other locations
- Aleris Ortopedi Ängelholm — Ängelholm, Skåne County, Sweden (Recruiting)
- Aleris Ortopedi Malmö — Malmö, Skåne County, Sweden (Active_not_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)
- Norrland University Hospital — Umeå, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.