Clinical trial NCT05817747: Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
Official title: Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constriction, Pathologic
Spine Degeneration
Surgery
Radiculopathy
Keywords: Spine
Cervical radiculopathy
Lumbar spinal stenosis
Surgery
Neck
Prognostic model
External validation
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: On all participants the dialogue support tool will be used and will thereafter be put into either of two treatment-arms (surgical, or non-surgical treatment)
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Global Assessment (GA)
timeFrame: One year post surgery
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: One year post surgery
measure: Neck Disability index (NDI)
timeFrame: One year post surgery
measure: Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)
timeFrame: One year post surgery
measure: Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)
timeFrame: One year post surgery
measure: Mortality
timeFrame: One year post surgery
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Aleris Ortopedi Malmö
state: Skåne
city: Ängelholm
country: Sweden
facility: Aleris Ortopedi Ängelholm
state: Skåne
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
city: Göteborg
country: Sweden
facility: Spine Center Göteborg
state: Västra Götaland
city: Stockholm
country: Sweden
facility: Ryggkirurgiskt Centrum
city: Stockholm
country: Sweden
facility: Spine Center Stockholm
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus
city: Umeå
country: Sweden
facility: Norrland University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Uppsala
country: Sweden
facility: Aleris Elisabethsjukhuset
Study officials:
affiliation: Sahlgrenska University Hospital
name: Catharina Parai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: