Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dialogue support tool.
- Who it may be relevant to
- Registry conditions: Constriction, Pathologic, Spine Degeneration, Surgery, Radiculopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Strategic Use of Big Data in Spine Surgery - Testing a Digital Prediction of Outcome Tool in Clinical Praxis
Overview
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.
Interventions
- Other Dialogue support tool
The dialogue support tool will be used as a support for the participant and surgeon to decide on which treatment arm is optimal for the participant.
Primary outcome measures
- Global Assessment (GA) [Time frame: One year post surgery]
Secondary outcome measures (5)
- Oswestry Disability Index (ODI) [Time frame: One year post surgery]
- Neck Disability index (NDI) [Time frame: One year post surgery]
- Euroqol-5-Dimensions quality of life questionnaire (EQ-5D) [Time frame: One year post surgery]
- Numeric Rating Scales for back/neck and leg/arm pain respectively (NRS) [Time frame: One year post surgery]
- Mortality [Time frame: One year post surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 10 centers
- Aleris Ortopedi Ängelholm — Ängelholm
- Aleris Ortopedi Malmö — Malmö
- Sahlgrenska University Hospital — Gothenburg
- Spine Center Göteborg — Gothenburg
- Ryggkirurgiskt Centrum — Stockholm
- Spine Center Stockholm — Stockholm
- Sundsvalls sjukhus — Sundsvall
- Norrland University Hospital — Umeå
- … and 2 more centers
Publications
- Enger EB, Valentin-Askman L, Hagg O, Fritzell P, Parai C. The strategic use of Big Data - A study protocol for a multicenter clinical trial testing if the use of the Swespine Dialogue Support alter outcomes in degenerative spine surgery. BMC Musculoskelet Disord. 2024 Aug 21;25(1):654. doi: 10.1186/s12891-024-07714-5. PMID 39169349
Identifiers
NCT: NCT05817747 · 2022-2025