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NCT Number: NCT06249958

Transforming Rehabilitation: Personalised Care for a Better Quality of Life

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.

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Key information

Conditions

Osteoarthritis Secondary Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis Primary Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, Italia, 20157, Italy

Location status: Recruiting

Location contact

Federico Pennestri, PhD

CONTACT

[email protected]

0283502224

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

rehabilitation

Other

Specific rehabilitation exercises

Verticalisation

Other

Day of patient verticalisation after surgery

Primary outcomes

  1. Barthel Index Total score

    Time frame: through study completion, within four years

    0-100, the higher, the better

  2. Functional autonomy measure (total score)

    Time frame: through study completion, within four years

    0-126, the higher, the better

  3. Standard hospital evaluation of patient gait

    Time frame: through study completion, within four years

    Autonomous, autonomous maximum 50 metres, or non autonomous.

  4. Standard hospital evaluation of walking aids needed by the patient

    Time frame: through study completion, within four years

    Crutches, stick, walker.

  5. Standard hospital evaluation of place of discharge

    Time frame: through study completion, within four years

    Home with relatives, home alone, residential care facility.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Pennestri, PhD

CONTACT

[email protected]

0283502224

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

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

Acronym: PREPARE

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

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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