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

Last updated: April 22, 2024
Sponsor: Sahlgrenska University Hospital, Sweden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Radiculopathy

Treatment

Dialogue support tool

Clinical Study ID

NCT05817747
2022-2025
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Refered to a participating clinic regarding surgery for lumbar spinal stenosis orcervical radiculopathy
  • 18 years of age or older
  • Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming thediagnosis, concurrent with symptoms described by the referring physician
  • Giving informed consent

Exclusion

Exclusion Criteria:

  • 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 doctorvisit.

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Dialogue support tool
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
March 01, 2029

Connect with a study center

  • Aleris Ortopedi Malmö

    Malmö, Skåne 21532
    Sweden

    Active - Recruiting

  • Aleris Ortopedi Ängelholm

    Ängelholm, Skåne 26252
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland 41346
    Sweden

    Active - Recruiting

  • Spine Center Göteborg

    Göteborg, Västra Götaland 421 30
    Sweden

    Active - Recruiting

  • Ryggkirurgiskt Centrum

    Stockholm, 114 33
    Sweden

    Active - Recruiting

  • Spine Center Stockholm

    Stockholm, 194 89
    Sweden

    Active - Recruiting

  • Norrland University Hospital

    Umeå, 90737
    Sweden

    Site Not Available

  • Aleris Elisabethsjukhuset

    Uppsala, 752 26
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala, 751 85
    Sweden

    Active - Recruiting

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