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

Condition(s) studied

Investigational drug(s) / intervention(s)

Dialogue 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.

Study 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

Primary outcome measure(s)

• Global Assessment (GA) — One year post surgery
  A retrospective single-item question ("How is your back/leg or neck/arm pain today as compared to before the surgery?"), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse).

Trial sites (10)

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