Prepare II - Predictive Model Training and External Validation

December 11, 2025 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, Phase 2)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The following variables will be investigated to evaluate their predictive value towards length of rehabilitation stay (primary outcome), place of discharge, burden of care at discharge and/or functional recovery (secondary outcomes):

  • Patient age at admission
  • Patient sex
  • Patient profession
  • Living status (e.g. home or residential unit)
  • Diagnosis
  • Surgical procedure
  • American Society of Anesthesiologists Score
  • Body Mass Index before surgery
  • Day of surgery
  • Duration of surgery (minutes)
  • Surgical access technique
  • Surgical ward stay
  • Pre-existing comorbidities
  • Pharmacological treatment of pre-existing conditions
  • Hemoglobin levels at inpatient rehabilitation admission
  • Pain (Numeric Rating Scale) at inpatient rehabilitation admission
  • Function - cognitive domains at inpatient rehab admission
  • Barthel Index of Activities of Daily Living (ADL) at inpatient rehab admission
  • Physiotherapic functional evaluations
  • Rehabilitation program
  • Function - cognitive domains at inpatient rehab discharge
  • Inpatient rehabilitation stay
  • Place of discharge
  • Use of walking aids at discharge
  • Need of assistance with the ADL at discharge
  • Barthel Index of Activities of Daily Living at inpatient rehab admission

Due to retrospective study design, patients will not be recruited ex-novo and will be used data already stored in the internal databases.

Data retrieved from clinical records and other sets internal to the hospital will be collected on a dedicated Excel sheet and divided per section of interest (baseline, intervention, outcomes).

Data from 1710 patients who underwent total hip or knee replacement and subsequent inpatient rehabilitation in our hospital were collected, in the previous part of this project, to train the model.

In this second part, the same variables from 400 patients will be collected to test the model predictivity. Put together, these samples represent around 80% and 20% of the total population (2100) respectively, which is a common cohort distribution to test for validity.

To verify the validity (discrimination and calibration) of the newly developed prediction and stratification models, we will conduct a temporal external validation based on a sample of newly collected patients undergoing hip and knee at the same hospital but at a different point in time (2018, as compared to 2019 for the development sample).

To this aim, we plan to include a convenience sample of at least 400 patients: the sample size was determined based on a minimum sample size calculation, using Hoeffding's inequality (DOI: 10.1016/j.jspi.2012.09.013), which is sufficient to identify differences in performance smaller than 10% performance points with confidence higher than 95% (minimum sample size=390).

Basic modelling methodologies such as linear and logic regression will also be taken into consideration.

The best performing model for each outcome of interest will be finally selected.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Age < 18 years (if any).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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).

Other Names:
  • Pain management
  • Blood management
  • Iron diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of inpatient rehabilitation stay (days)
Time Frame: Up to 30 days
The number of days needed by the patient to be discharged in safety
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need of care at discharge
Time Frame: Last day of inpatient rehabilitation stay: up to 30 days
Hours of care (number) needed by the patient (estimation) to receive support on the Activities of Daily Living after hospital discharge.
Last day of inpatient rehabilitation stay: up to 30 days
Place of discharge
Time Frame: Last day of inpatient rehabilitation stay: up to 30 days.
Home, home with care givers, other inpatient unit.
Last day of inpatient rehabilitation stay: up to 30 days.
Barthel Index of autonomy in Activities of Daily Living (ADL)
Time Frame: Last day of inpatient rehabilitation stay: up to 30 days.
Score 0-100 in both scales.
Last day of inpatient rehabilitation stay: up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Federico Pennestrì, PhD, IRCCS Ospedale Galeazzi Sant'Ambrogio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prepare II
  • Project 101080288 - PREPARE (Other Grant/Funding Number: EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers of the same facility will scan paper records to retrieve patient data.

No sensitive data will leave the hospital.

IPD Sharing Time Frame

Study protocol is already completed and available. Informed consent is given based on retrospective study policy guidelines from the Ministry of Health.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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