Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-04-04; most recent amendment 2025-05-12.
Trial Details
NCT Number NCT05817747
Lead Sponsor Sahlgrenska University Hospital
Conditions Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy
Enrollment 900 participants
Start Date 2022-03-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-13