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

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Constriction, Pathologic; Radiculopathy; Surgery; Spine Degeneration

Treatments: Other: Dialogue support tool

Study type: Interventional

Funder types: Other

Identifiers

NCT05817747

2022-2025

Details and patient eligibility

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups, including a placebo group

Surgery

Experimental group

Description:

Participants will after the dialogue support tool has been undergo surgery.

Treatment:

Other: Dialogue support tool

Non-surgery

Placebo Comparator group

Description:

Participants will after the dialogue support tool has been used not undergo surgery.

Treatment:

Other: Dialogue support tool