Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constriction, Pathologic
- Sponsor
- Sahlgrenska University Hospital
- Enrollment
- 900
- Locations
- 10
- Primary Endpoint
- Global Assessment (GA)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Catharina Parai, MD, PhD
Principal Investigator
Sahlgrenska University Hospital
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.
Outcomes
Primary Outcomes
Global Assessment (GA)
Time Frame: One year post surgery
A retrospective single-item question ("How is your back/leg or neck/arm pain today as compared to before the surgery?"), with six response options (not back/leg pain before surgery/completely gone/much improved/slightly improved/unchanged/worse).
Secondary Outcomes
- Mortality(One year post surgery)
- Oswestry Disability Index (ODI)(One year post surgery)
- Euroqol-5-Dimensions quality of life questionnaire (EQ-5D)(One year post surgery)
- Neck Disability index (NDI)(One year post surgery)
- Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS)(One year post surgery)