Optimization of a Tool for Predicting Postoperative Clinical Evolution After Lumbar Surgery

Cortexx Medical Intelligence119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

119

Conditions

Spine Disease Spinal Fusion Surgery Spine Degeneration

Interventions

SuMO PatientDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Polyclinique Jean Villar

Bruges, New Aquitaine, France

Clinique Geoffroy Saint-Hilaire

Paris, France

Outcomes

Primary Outcomes

Optimization of a tool for predicting the postoperative clinical course after lumbar surgery

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).

Time frame: 14 months

Secondary Outcomes

Collection of optimized data in the patient operative long terms care

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

Time frame: 14 months

Data from ClinicalTrials.gov

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