Spinal Fusion, Spine Degeneration, Spine Disease, Surgery
Conditions
Brief summary
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green (success) orange (treatment failure ), red patient (complication) in order to optimize his medical care up to 6 months.
Interventions
DIAGNOSTIC_TESTSuMO Patient
The current study is interventional insofar as the patient is collecting all of his socio-medical information. The analysis of the data provided by the patient makes it possible to establish a long-term prognosis for the patient but does not in itself constitute a parallel medical approach. SUMO allows the surgeon to transmit post-operative advice developed by the surgeons themselves.
Sponsors
Ramsay Générale de Santé
Elsan
Malakoff-Humanis
Cortexx Medical Intelligence
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The patient will be required to complete a guided digital questionnaire at each follow-up assessment. This questionnaire will be completed online by the patient in the Surgery Medical Outcomes (SuMO system) system developped by the Society Cortexx Medical Intelligence. The system access procedures and connection codes will be known to the patient by the investigating physician. Patients will, throughout the study, be automatically informed via the SUMO system of the availability of data to be completed. The security of patient data is guaranteed by encrypted and separate storage of medical data, in order to comply with applicable regulatory requirements.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major patient * Eligible for lumbar decompression surgery, instrumented or not * Social insured * Having given consent * Eligible for the acts described in Protocole
Exclusion criteria
* Minor * Pregnant or breastfeeding woman * Safeguard measure or guardianship * Arthrodesis on more than 2 levels * Interventions linked to a traumatic or infectious context are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimization of a tool for predicting the postoperative clinical course after lumbar surgery | 14 months | Establishment and prospective evaluation of a predictive tool with the area under the receiver operating characteristic (AUROC) metric \>= 80% Sensitivity \>= 90% Specificity \>= 60% in the capacity of providing for each back operated patient a clinical predictive status: green patient (success) orange (treatment failure), red patient (complication). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of optimized data in the patient operative long terms care | 14 months | Implementation, optimization and evaluation of a digital tool for collecting patient data on the episode of care Outcome (unit) - Result expected assessment time connection means preoperatively (second/connection) - 300s time 'use and navigation (second) - 1800s number of connections made by the patient preoperatively (number) - 5 number of connections / day before operation (number) - 1 number of use (number) - 15 number of drops / connection (Ratio%) - \<20% number of lost view (no connection\> 20 days) (Ratio%) - \<10% evaluation of average using time post-operative (second/connections) - 300 Time of use and navigation (second) - 1800 number of connections made by the patient in post -operative (number) - 5 number of connections / day after operation (number)- 1 number of uses (number) - 15 number of withdrawals (Ratio%) - \<20% number of lost to follow-up (no connection\> 20 days) (Ratio%) - \<10% number of documents analyzed / patient (number) - 10 |
Countries
France
Outcome results
None listed