Osteoarthritis SecondaryPREPARENCT06249958
Transforming Rehabilitation: Personalised Care for a Better Quality of Life
An observational study of Osteoarthritis Secondary and Osteoarthritis Primary, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Secondary, Osteoarthritis Primary, Osteoarthritis, Knee
- What is being tested?
- Rehabilitation and Verticalisation
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2024to 8 Jan 2027
- 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: 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.
Who may be able to join
- Patients admitted for inpatient surgery at IRCCS Galeazzi Orthopedic Institute in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
- Ages ≥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
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italia, 20157
Federico Pennestri, PhD, 0283502224, federico.pennestri@grupposandonato.it
About this study
Official title: Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, 1st Part)
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.
Read the detailed description
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:
- Pre-surgery
- Surgical procedure
- Inpatient rehabilitation
- Post discharge, if available, at 3,6,12,24,60 months.
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:
- Patients admitted for inpatient surgery at IOG in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
- Ages ≥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).
No exclusion criteria.
- Conditions
- Osteoarthritis Secondary, Osteoarthritis Primary, Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Rehabilitation, Verticalisation
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Specific rehabilitation exercises
VerticalisationOther
Day of patient verticalisation after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index Total score
0-100, the higher, the better
Measured: through study completion, within four years
Functional autonomy measure (total score)
0-126, the higher, the better
Measured: through study completion, within four years
Standard hospital evaluation of patient gait
Autonomous, autonomous maximum 50 metres, or non autonomous.
Measured: through study completion, within four years
Standard hospital evaluation of walking aids needed by the patient
Crutches, stick, walker.
Measured: through study completion, within four years
Standard hospital evaluation of place of discharge
Home with relatives, home alone, residential care facility.
Measured: 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.
Measured: 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.
Measured: through study completion, within four years
Functional autonomy measure subdomains
Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.
Measured: through study completion, within four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start8 Jan 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion8 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis SecondaryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- 2,000 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249958
- Sponsor's protocol ID
- PREPARE
- Acronym
- PREPARE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. 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, 1st Part)
- ClinicalTrials.gov ID
- NCT06249958
- Acronym / sponsor ID
- PREPARE / PREPARE
- Conditions
- Osteoarthritis Secondary, Osteoarthritis Primary, Osteoarthritis, Knee, Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 8 Jan 2027 (estimated)
- First posted
- 8 Feb 2024 (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.
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.
Detailed description
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:
- Pre-surgery
- Surgical procedure
- Inpatient rehabilitation
- Post discharge, if available, at 3,6,12,24,60 months.
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:
- Patients admitted for inpatient surgery at IOG in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
- Ages ≥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).
No exclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Patients admitted for inpatient surgery at IRCCS Galeazzi Orthopedic Institute in 2019 (January-December) and subsequently discharged to inpatient rehabilitation in the same structure.
- Ages ≥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 (0 listed)
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 |
|---|---|---|
| RehabilitationSpecific rehabilitation exercises | Other | – |
| VerticalisationDay of patient verticalisation after surgery | Other | – |
Primary outcome
Barthel Index Total score
Time frame: through study completion, within four years
0-100, the higher, the better
Functional autonomy measure (total score)
Time frame: through study completion, within four years
0-126, the higher, the better
Standard hospital evaluation of patient gait
Time frame: through study completion, within four years
Autonomous, autonomous maximum 50 metres, or non autonomous.
Standard hospital evaluation of walking aids needed by the patient
Time frame: through study completion, within four years
Crutches, stick, walker.
Standard hospital evaluation of place of discharge
Time frame: through study completion, within four years
Home with relatives, home alone, residential care facility.
Standard hospital evaluation of care burden at discharge
Time frame: through study completion, within four years
Less than 6 hours a day; less than 3 hours a day; no burden.
Patient-reported outcomes
Time frame: through study completion, within four years
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.
Functional autonomy measure subdomains
Time frame: through study completion, within four years
Mobility, 3-21, the higher, the better; Cognition, 3-21, the higher, the better.
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 8 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 Osteoarthritis Secondary and Osteoarthritis Primary, 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 0 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 8 Feb 2024. 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 Federico Pennestri, PhD (0283502224, federico.pennestri@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index Total score (time frame: through study completion, within four years). The study lists 8 primary outcomes in all. 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 8 Feb 2024.