NCT05817747 Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
| NCT ID | NCT05817747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Constriction, Pathologic |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 900 participants in total. It began in 2022-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria: * Refered 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 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 doctor visit.
Contact & Investigator
Catharina Parai, MD, PhD
PRINCIPAL INVESTIGATOR
Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT05817747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Constriction, Pathologic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05817747 currently recruiting?
Yes, NCT05817747 is actively recruiting participants. Contact the research team at catharina.parai@vgregion.se for enrollment information.
Where is the NCT05817747 trial being conducted?
This trial is being conducted at Ängelholm, Sweden, Malmö, Sweden, Gothenburg, Sweden, Gothenburg, Sweden and 6 additional locations.
Who is sponsoring the NCT05817747 clinical trial?
NCT05817747 is sponsored by Sahlgrenska University Hospital. The principal investigator is Catharina Parai, MD, PhD at Sahlgrenska University Hospital. The trial plans to enroll 900 participants.