HIP AND KNEE OSTEOARTHRITISNCT07304323
Prepare II - Predictive Model Training and External Validation
An observational study of HIP AND KNEE OSTEOARTHRITIS, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIP AND KNEE OSTEOARTHRITIS
- What is being tested?
- Functional rehabilitation
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to inpatient rehabilitation unit after discharged from surgical ward.
Who may be able to join
- 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).
Who cannot join
- Age < 18 years (if any).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Coordinator of the Scientific Direction contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20157
Federico Coordinator of the Scientific Direction, +39 0283502224, direzionescientifica.ogsa@grupposandonato.it
Grant office operator, +39 0283502227, pennestri.federico@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- HIP AND KNEE OSTEOARTHRITIS
- Being tested
- Functional rehabilitation
- Keywords
- total joint arthroplasty, osteoarthritis, total joint replacement, inpatient rehabilitation, predictive model, rehabilitation outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional rehabilitationOther
Also called Pain management, Blood management, Iron diet
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of inpatient rehabilitation stay (days)
The number of days needed by the patient to be discharged in safety
Measured: Up to 30 days
Secondary outcomes (3)
Need of care at discharge
Hours of care (number) needed by the patient (estimation) to receive support on the Activities of Daily Living after hospital discharge.
Measured: Last day of inpatient rehabilitation stay: up to 30 days
Place of discharge
Home, home with care givers, other inpatient unit.
Measured: Last day of inpatient rehabilitation stay: up to 30 days.
Barthel Index of autonomy in Activities of Daily Living (ADL)
Score 0-100 in both scales.
Measured: Last day of inpatient rehabilitation stay: up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIP AND KNEE OSTEOARTHRITISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico Pennestrì, PhD, Principal investigator, IRCCS Ospedale Galeazzi Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304323
- Sponsor's protocol ID
- Prepare II
- Other IDs
- Project 101080288 - PREPARE
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers of the same facility will scan paper records to retrieve patient data. No sensitive data will leave the hospital.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, Phase 2)
- ClinicalTrials.gov ID
- NCT07304323
- Acronym / sponsor ID
- Prepare II
- Conditions
- HIP AND KNEE OSTEOARTHRITIS
- Keywords
- total joint arthroplasty, osteoarthritis, total joint replacement, inpatient rehabilitation, predictive model, rehabilitation outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis | – | Other: Functional rehabilitationPatients discharged directly to inpatient rehabilitation unit in the same hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to inpatient rehabilitation unit after discharged from surgical ward.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Age < 18 years (if any).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional rehabilitationAlso: Pain management, Blood management, Iron dietFunctional 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 | Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis |
Primary outcome
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
3 secondary outcomes
Need of care at discharge
Time frame: 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.
Barthel Index of autonomy in Activities of Daily Living (ADL)
Time frame: Last day of inpatient rehabilitation stay: up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: Yes. Researchers of the same facility will scan paper records to retrieve patient data. No sensitive data will leave the hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coordinator of the Scientific Direction contact
Federico Pennestrì, PhD principal investigator
IRCCS Ospedale Galeazzi Sant'Ambrogio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIP AND KNEE OSTEOARTHRITIS, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coordinator of the Scientific Direction (+39 0283502224, direzionescientifica.ogsa@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of inpatient rehabilitation stay (days) (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.