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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Aleris Ortopedi Ängelholm
RECRUITING
Ängelholm
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Spine Center Göteborg
RECRUITING
Gothenburg
Aleris Ortopedi Malmö
ACTIVE_NOT_RECRUITING
Malmo
Ryggkirurgiskt Centrum
RECRUITING
Stockholm
Spine Center Stockholm
RECRUITING
Stockholm
Sundsvalls sjukhus
RECRUITING
Sundsvall
Norrland University Hospital
RECRUITING
Umeå
Aleris Elisabethsjukhuset
ACTIVE_NOT_RECRUITING
Uppsala
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Catharina Parai, MD, PhD
catharina.parai@vgregion.se
0046313421000
Backup
Eric Brisby Enger, MD
ericbrisbyenger@gmail.com
0046735716723
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 900
Treatments
Experimental: Surgery
Participants will after the dialogue support tool has been undergo surgery.
Placebo_comparator: Non-surgery
Participants will after the dialogue support tool has been used not undergo surgery.
Related Therapeutic Areas
Sponsors
Leads: Sahlgrenska University Hospital

This content was sourced from clinicaltrials.gov