Transforming Rehabilitation: Personalised Care for a Better Quality of Life

Osteoarthritis, Knee Clinical Trial

— PREPARE  

Official title:

Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, 1st Part)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249958
• Other study ID #: PREPARE
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: January 8, 2027

Study information

• Verified date: January 2024
• Source: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Contact: Federico Pennestri, PhD
• Phone: 0283502224
• Email: federico.pennestri[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 8, 2027
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• Rehabilitation
Specific rehabilitation exercises
• Verticalisation
Day of patient verticalisation after surgery

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Galeazzi Sant'Ambrogio	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index Total score	0-100, the higher, the better	through study completion, within four years
Primary	Functional autonomy measure (total score)	0-126, the higher, the better	through study completion, within four years
Primary	Standard hospital evaluation of patient gait	Autonomous, autonomous maximum 50 metres, or non autonomous.	through study completion, within four years
Primary	Standard hospital evaluation of walking aids needed by the patient	Crutches, stick, walker.	through study completion, within four years
Primary	Standard hospital evaluation of place of discharge	Home with relatives, home alone, residential care facility.	through study completion, within four years
Primary	Standard hospital evaluation of care burden at discharge	Less than 6 hours a day; less than 3 hours a day; no burden.	through study completion, within four years
Primary	Patient-reported outcomes	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
Primary	Functional autonomy measure subdomains	Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.	through study completion, within four years