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OpenTrials
Completed

NCT Number: NCT05166018

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Jean Villar, Bruges, New Aquitaine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SuMO Patient

Diagnostic 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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Collection of optimized data in the patient operative long terms care

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cortexx Medical Intelligence

Industry

Collaborators

  • Elsan
  • GCS Ramsay Santé pour l'Enseignement et la Recherche
  • Malakoff-Humanis

Registry information

Official study title

Optimization of a Tool for Predicting Postoperative Clinical Evolution After Lumbar Surgery Multicenter Longitudinal Prospective Study on a National Cohort Clinical Evolution After Lumbar Surgery

Acronym: DeepSurgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2021
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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