Prepare II - Predictive Model Training and External Validation

NCT07304323 | Recruiting

• 2 other identifiers: Prepare IIProject 101080288 - PREPARE
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The general aim of the project is training and testing a predictive model of inpatient rehabilitation stay after hip and knee replacement for osteoarthritis. This specific part focuses on data collection and analysis for the model validation.

Conditions

HIP AND KNEE OSTEOARTHRITIS

Keywords

total joint arthroplasty; osteoarthritis; total joint replacement; inpatient rehabilitation; predictive model; rehabilitation outcomes

Outcome Measures

Primary Outcomes (1)

• Length of inpatient rehabilitation stay (days)

  The number of days needed by the patient to be discharged in safety

  Up to 30 days

Secondary Outcomes (3)

• Need of care at discharge

  Last day of inpatient rehabilitation stay: up to 30 days

• Place of discharge

  Last day of inpatient rehabilitation stay: up to 30 days.

• Barthel Index of autonomy in Activities of Daily Living (ADL)

  Last day of inpatient rehabilitation stay: up to 30 days.

Study Arms (1)

Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis

Patients discharged directly to inpatient rehabilitation unit in the same hospital.

Other: Functional rehabilitation

Interventions

Functional rehabilitation OTHER

Functional rehabilitation is standardized educational and physical therapy to restore physical and activities of daily living function before discharge. Pain management, blood management and iron diet are also provided based on standard conditions (e.g. patient-reported pain, postoperative day and hemoglobin levels).

Also known as: Pain management, Blood management, Iron diet

Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis

Eligibility Criteria

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

Study Population

Patients admitted to inpatient rehabilitation unit after discharged from surgical ward.

You may qualify if:

• Patients admitted for THR and TKR at IRCCS Galeazzi Orthopedic Institute in 2018 (any month) and subsequently discharged to inpatient rehabilitation in the same structure.
• Aged ≥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).

You may not qualify if:

• Age \< 18 years (if any).

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Federico Pennestrì, PhD

  IRCCS Ospedale Galeazzi Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coordinator of the Scientific Direction

CONTACT

+39 0283502224; direzionescientifica.ogsa@grupposandonato.it

Grant office operator

CONTACT

+39 0283502227; pennestri.federico@gmail.com

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 26, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol is already completed and available. Informed consent is given based on retrospective study policy guidelines from the Ministry of Health.
• Access Criteria: The researchers employed on the project will have access to paper-scan clinical records in a pdf format, either from the internal, protected database, or from a Compact Disc record.

Locations

IT (1)