Transforming Rehabilitation: Personalised Care for a Better Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehabilitation, Verticalisation.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Secondary, Osteoarthritis Primary, Osteoarthritis, Knee, Osteoarthritis, Hip. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, 1st Part)
Overview
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.
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.
Interventions
- Other Rehabilitation
Specific rehabilitation exercises - Other Verticalisation
Day of patient verticalisation after surgery
Primary outcome measures
- Barthel Index Total score [Time frame: through study completion, within four years]
- Functional autonomy measure (total score) [Time frame: through study completion, within four years]
- Standard hospital evaluation of patient gait [Time frame: through study completion, within four years]
- Standard hospital evaluation of walking aids needed by the patient [Time frame: through study completion, within four years]
- Standard hospital evaluation of place of discharge [Time frame: through study completion, within four years]
- Standard hospital evaluation of care burden at discharge [Time frame: through study completion, within four years]
- Patient-reported outcomes [Time frame: through study completion, within four years]
- Functional autonomy measure subdomains [Time frame: through study completion, within four years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale Galeazzi Sant'Ambrogio — Milan
Identifiers
NCT: NCT06249958 · PREPARE