Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
NCT ID: NCT05817747
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2022-03-01
2029-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
Participants will after the dialogue support tool has been undergo surgery.
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.
Non-surgery
Participants will after the dialogue support tool has been used not undergo surgery.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Not giving informed consent
* Need for further investigation that prevents inclusion within one month of the doctor visit.
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Catharina Parai, MD, PhD
Principal Investigator
Principal Investigators
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Catharina Parai, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Björn Knutsson, MD, PhD
Role: primary
References
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Enger EB, Valentin-Askman L, Hagg O, Fritzell P, Parai C. The strategic use of Big Data - A study protocol for a multicenter clinical trial testing if the use of the Swespine Dialogue Support alter outcomes in degenerative spine surgery. BMC Musculoskelet Disord. 2024 Aug 21;25(1):654. doi: 10.1186/s12891-024-07714-5.
Other Identifiers
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2022-2025
Identifier Type: -
Identifier Source: org_study_id
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