Prepare II - Predictive Model Training and External Validation
NCT ID: NCT07304323
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2025-10-08
2026-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Principal Investigators
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Federico Pennestrì, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale Galeazzi Sant'Ambrogio
Locations
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IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, , Italy
Countries
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Central Contacts
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Coordinator of the Scientific Direction
Role: CONTACT
Phone: +39 0283502224
Email: [email protected]
Facility Contacts
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Federico Coordinator of the Scientific Direction
Role: primary
Grant office operator
Role: backup
Other Identifiers
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Project 101080288 - PREPARE
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Prepare II
Identifier Type: -
Identifier Source: org_study_id