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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dialogue support tool

Treatment groups

900 Participants
are divided into 2 treatment groups