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

Inclusion Criteria4

  • Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy
  • 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

Exclusion Criteria3

  • 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.

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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

Malmo, 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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