RecruitingNot ApplicableNCT05817747

Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis


Sponsor

Sahlgrenska University Hospital

Enrollment

900 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice. The main questions it aims to answer are: * Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis? * Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy? * How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery? Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon. Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses artificial intelligence and big data to predict surgical outcomes for patients with two common spinal conditions: lumbar spinal stenosis (narrowing of the spinal canal in the lower back) and cervical radiculopathy (nerve compression in the neck). Back and neck surgery carries real risks, and outcomes vary widely — predicting in advance which patients will benefit most from surgery could help surgeons and patients make better decisions. Eligible participants are adults aged 18 or older who are referred for surgery for one of these two conditions, have had recent MRI confirming their diagnosis, and provide informed consent. Those whose symptoms turn out to be caused by another condition or who cannot be enrolled within one month of the initial consultation are excluded. Participants complete digital questionnaires before and after surgery, and their outcomes are compared against AI model predictions to test how accurately the tool performs in clinical practice. Spinal surgery decisions are often difficult, with patients and doctors navigating genuine uncertainty. A validated prediction tool could reduce unnecessary surgeries, spare patients from procedures unlikely to help them, and help direct surgical resources toward those who will benefit most — improving both patient outcomes and healthcare efficiency.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDialogue support tool

The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.


Locations(10)

Aleris Ortopedi Ängelholm

Ängelholm, Skåne County, Sweden

Aleris Ortopedi Malmö

Malmö, Skåne County, Sweden

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Spine Center Göteborg

Gothenburg, Västra Götaland County, Sweden

Ryggkirurgiskt Centrum

Stockholm, Sweden

Spine Center Stockholm

Stockholm, Sweden

Sundsvalls sjukhus

Sundsvall, Sweden

Norrland University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

Aleris Elisabethsjukhuset

Uppsala, Sweden

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NCT05817747


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