Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05817747

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

Led by Sahlgrenska University Hospital · Updated on 2025-05-13

900

Participants Needed

10

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Referred 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Aleris Ortopedi Ängelholm

Ängelholm, Skåne County, Sweden, 26252

Actively Recruiting

2

Aleris Ortopedi Malmö

Malmö, Skåne County, Sweden, 21532

Active, Not Recruiting

3

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden, 41346

Actively Recruiting

4

Spine Center Göteborg

Gothenburg, Västra Götaland County, Sweden, 421 30

Actively Recruiting

5

Ryggkirurgiskt Centrum

Stockholm, Sweden, 114 33

Actively Recruiting

6

Spine Center Stockholm

Stockholm, Sweden, 194 89

Actively Recruiting

7

Sundsvalls sjukhus

Sundsvall, Sweden

Actively Recruiting

8

Norrland University Hospital

Umeå, Sweden, 90737

Actively Recruiting

9

Uppsala University Hospital

Uppsala, Sweden, 751 85

Actively Recruiting

10

Aleris Elisabethsjukhuset

Uppsala, Sweden, 752 26

Active, Not Recruiting

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Research Team

C

Catharina Parai, MD, PhD

CONTACT

E

Eric Brisby Enger, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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