IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20157, Italy
Location status: Recruiting
Location contact
Federico Coordinator of the Scientific Direction
CONTACT
Federico Pennestrì, PhD
PRINCIPAL_INVESTIGATOR
Grant office operator
CONTACT
NCT Number: NCT07304323
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milan, 20157, Italy
Location status: Recruiting
Federico Coordinator of the Scientific Direction
CONTACT
Federico Pennestrì, PhD
PRINCIPAL_INVESTIGATOR
Grant office operator
CONTACT
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):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Up to 30 days
The number of days needed by the patient to be discharged in safety
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.
Time frame: Last day of inpatient rehabilitation stay: up to 30 days.
Home, home with care givers, other inpatient unit.
Time frame: Last day of inpatient rehabilitation stay: up to 30 days.
Score 0-100 in both scales.
Contact information is provided by the study sponsor or research team.
Coordinator of the Scientific Direction
CONTACT
Grant office operator
CONTACT
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Other
Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, Phase 2)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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