Transforming Rehabilitation: Personalised Care for a Better Quality of Life

Save

Report Abuse

Description

General aim of the project: building and validating an Artificial Intelligence (AI)-based prediction model on rehabilitation outcomes (total joint replacement - TJR - of the hip and knee for primary and secondary osteoarthritis)

Purpose of this specific approval request: identifying data from patients admitted for total joint replacement surgery (hip and knee) at Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Galeazzi (IOG) in 2019 and subsequently discharged to inpatient rehabilitation in the same institution.

Study Overview

Start Date
January 8, 2024
Completion Date
January 8, 2027
Enrollment
2000
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milano, Italia 20157, Italy

Eligibility

Study Population
Adult patients undergoing a) hip or knee prostethic surgery after primary or secondary osteoarthritis at Galeazzi Orthopedic Hospital, year 2019; b) subsequent inpatient rehabilitation at the same facility.
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Patients admitted for inpatient surgery at IRCCS Galeazzi Orthopedic Institute in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
Ages ≥18 years
International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee)
ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).

Exclusion Criteria: N/A

Study Contact Info

Study Contact Name
Federico Pennestri, PhD
Study Contact Phone

Contact Listings Owner Form

Transforming Rehabilitation: Personalised Care for a Better Quality of Life 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The aim is to collect data from patients undergoing elective TJR (baseline, intervention, outcomes) in order to generate and train an AI algorithm.

Patient characteristics (diagnosis, sex, age, American Society of Anesthesiologists (ASA) score, profession, haemoglobin levels, pain, functional autonomy, care giver presence at home), intervention characteristics (surgical procedure, day of surgery, duration of surgery, infection occurrence, need of transfusion, length of hospital stay, verticalization day, rehabilitation program) and outcomes (Barthel Index, functional independence measures, care burden, Patient Reported Outcomes - PROs - when available ) are collected by the Principal Investigator in a dedicated Excel sheet.

The dataset includes information from the entire perioperative care:

Pre-surgery
Surgical procedure
Inpatient rehabilitation
Post discharge, if available, at 3,6,12,24,60 months.

Such new dataset will by employed to enable a software whose goal is to provide a predictive model for rehabilitation outcomes, which future application would be helping clinicians design evidence-based, personalized rehabilitation programs. The software will be developed by dedicated data science partners within the European Health and Digital Executive Agency (HADEA) research Project n. 101080288, PREPARE.

The study will include elective prosthetic surgery (TJR of the hip and knee) performed in 2019 (January-December) and the subsequent inpatient rehabilitation program.

Data collection will start after approval from the Ethical Committee (EC) and the new dataset must be available before spring 2024. However, retrieving further data may result necessary by general project needs which are currently not entirely foreseeable, therefore we ask authorization for the entire study duration of four years.

Inclusion criteria:

Patients admitted for inpatient surgery at IOG in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
Ages ≥18 years
International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee)
ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).

No exclusion criteria.
NCTid (if applicable)
NCT06249958