Transforming Rehabilitation: Personalised Care for a Better Quality of Life

NCT06249958 | Recruiting

• 1 other identifier: PREPARE
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis Secondary; Osteoarthritis Primary; Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (8)

• Barthel Index Total score

  0-100, the higher, the better

  through study completion, within four years

• Functional autonomy measure (total score)

  0-126, the higher, the better

  through study completion, within four years

• Standard hospital evaluation of patient gait

  Autonomous, autonomous maximum 50 metres, or non autonomous.

  through study completion, within four years

• Standard hospital evaluation of walking aids needed by the patient

  Crutches, stick, walker.

  through study completion, within four years

• Standard hospital evaluation of place of discharge

  Home with relatives, home alone, residential care facility.

  through study completion, within four years

• 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

• 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

• Functional autonomy measure subdomains

  Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.

  through study completion, within four years

Interventions

Rehabilitation OTHER

Specific rehabilitation exercises

Verticalisation OTHER

Day of patient verticalisation after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, Italia, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Federico Pennestri, PhD

CONTACT

0283502224; federico.pennestri@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 8, 2024
• Study Start: January 8, 2024
• Primary Completion: June 30, 2024
• Study Completion (Estimated): January 8, 2027
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)