An observational study in Osteoarthritis Secondary, Osteoarthritis Primary and Osteoarthritis, Knee, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
General aim of the project: building and validating an Artificial Intelligence (AI)-based prediction model on rehabilitation outcomes (total joint replacement - TJR - of the hip and knee for primary and secondary osteoarthritis)
Purpose of this specific approval request: identifying data from patients admitted for total joint replacement surgery (hip and knee) at Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Istituto Ortopedico Galeazzi (IOG) in 2019 and subsequently discharged to inpatient rehabilitation in the same institution.
The aim is to collect data from patients undergoing elective TJR (baseline, intervention, outcomes) in order to generate and train an AI algorithm.
Patient characteristics (diagnosis, sex, age, American Society of Anesthesiologists (ASA) score, profession, haemoglobin levels, pain, functional autonomy, care giver presence at home), intervention characteristics (surgical procedure, day of surgery, duration of surgery, infection occurrence, need of transfusion, length of hospital stay, verticalization day, rehabilitation program) and outcomes (Barthel Index, functional independence measures, care burden, Patient Reported Outcomes - PROs - when available ) are collected by the Principal Investigator in a dedicated Excel sheet.
The dataset includes information from the entire perioperative care:
Such new dataset will by employed to enable a software whose goal is to provide a predictive model for rehabilitation outcomes, which future application would be helping clinicians design evidence-based, personalized rehabilitation programs. The software will be developed by dedicated data science partners within the European Health and Digital Executive Agency (HADEA) research Project n. 101080288, PREPARE.
The study will include elective prosthetic surgery (TJR of the hip and knee) performed in 2019 (January-December) and the subsequent inpatient rehabilitation program.
Data collection will start after approval from the Ethical Committee (EC) and the new dataset must be available before spring 2024. However, retrieving further data may result necessary by general project needs which are currently not entirely foreseeable, therefore we ask authorization for the entire study duration of four years.
Inclusion criteria:
No exclusion criteria.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing a) hip or knee prostethic surgery after primary or secondary osteoarthritis at Galeazzi Orthopedic Hospital, year 2019; b) subsequent inpatient rehabilitation at the same facility.
Inclusion Criteria:
Exclusion Criteria: N/A
Specific rehabilitation exercises
Day of patient verticalisation after surgery
Barthel Index Total score
0-100, the higher, the better
Time frame: through study completion, within four years
Functional autonomy measure (total score)
0-126, the higher, the better
Time frame: through study completion, within four years
Standard hospital evaluation of patient gait
Autonomous, autonomous maximum 50 metres, or non autonomous.
Time frame: through study completion, within four years
Standard hospital evaluation of walking aids needed by the patient
Crutches, stick, walker.
Time frame: through study completion, within four years
Standard hospital evaluation of place of discharge
Home with relatives, home alone, residential care facility.
Time frame: through study completion, within four years
Standard hospital evaluation of care burden at discharge
Less than 6 hours a day; less than 3 hours a day; no burden.
Time frame: through study completion, within four years
Patient-reported outcomes
Visual Analog Scale (VAS), 0-10, the higher, the better; Short-Form 12, Physical and Mental Scores, 0-100, the higher, the better; Euro QOL - 5 Dimension (EQ-5D), 0-100, the higher, the better; Hip Disability and Osteoarthritis Outcome Score (HOOS), 0-100, the higher, the better; Knee Injury and Osteoarthritis Outcome Score (KOOS), 0-100, the higher, the better.
Time frame: through study completion, within four years
Functional autonomy measure subdomains
Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.
Time frame: through study completion, within four years
Plan to share: No
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