- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06249958
Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE)
Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, 1st Part)
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
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Federico Pennestri, PhD
- Phone Number: 0283502224
- Email: federico.pennestri@grupposandonato.it
Study Locations
-
-
Italia
-
Milano, Italia, Italy, 20157
- Recruiting
- IRCCS Ospedale Galeazzi Sant'Ambrogio
-
Contact:
- Federico Pennestri, PhD
- Phone Number: 0283502224
- Email: federico.pennestri@grupposandonato.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel Index Total score
Time Frame: through study completion, within four years
|
0-100, the higher, the better
|
through study completion, within four years
|
Functional autonomy measure (total score)
Time Frame: through study completion, within four years
|
0-126, the higher, the better
|
through study completion, within four years
|
Standard hospital evaluation of patient gait
Time Frame: through study completion, within four years
|
Autonomous, autonomous maximum 50 metres, or non autonomous.
|
through study completion, within four years
|
Standard hospital evaluation of walking aids needed by the patient
Time Frame: through study completion, within four years
|
Crutches, stick, walker.
|
through study completion, within four years
|
Standard hospital evaluation of place of discharge
Time Frame: through study completion, within four years
|
Home with relatives, home alone, residential care facility.
|
through study completion, within four years
|
Standard hospital evaluation of care burden at discharge
Time Frame: through study completion, within four years
|
Less than 6 hours a day; less than 3 hours a day; no burden.
|
through study completion, within four years
|
Patient-reported outcomes
Time Frame: through study completion, within four years
|
Visual Analog Scale (VAS), 0-10, the higher, the better; Short-Form 12, Physical and Mental Scores, 0-100, the higher, the better; Euro QOL - 5 Dimension (EQ-5D), 0-100, the higher, the better; Hip Disability and Osteoarthritis Outcome Score (HOOS), 0-100, the higher, the better; Knee Injury and Osteoarthritis Outcome Score (KOOS), 0-100, the higher, the better.
|
through study completion, within four years
|
Functional autonomy measure subdomains
Time Frame: through study completion, within four years
|
Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.
|
through study completion, within four years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREPARE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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