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

Recruiting now · Not applicable

Conditions studied: Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy

In brief

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.

Key facts

Study ID

NCT05817747

Run by

Sahlgrenska University Hospital

People needed

900

Starts

2022-03-01

Expected to finish

2029-03-01

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Aleris Ortopedi Ängelholm — Ängelholm, Skåne County, Sweden (enrolling)
• Norrland University Hospital — Umeå, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (enrolling)
• Spine Center Göteborg — Gothenburg, Västra Götaland County, Sweden (enrolling)
• Ryggkirurgiskt Centrum — Stockholm, Sweden (enrolling)
• Spine Center Stockholm — Stockholm, Sweden (enrolling)
• Sundsvalls sjukhus — Sundsvall, Sweden (enrolling)
• Aleris Ortopedi Malmö — Malmö, Skåne County, Sweden
• Aleris Elisabethsjukhuset — Uppsala, Sweden

Full record on ClinicalTrials.gov

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