Hip OsteoarthritisNCT04960098
Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty
An observational study of Hip Osteoarthritis and Knee Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis, Prosthesis Survival
- What is being tested?
- arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 5,816 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2016to 31 Dec 2050
- How long will I take part?
- 10 Years
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients underwent hip and knee arthroplasty included in inclusion criteria
Who may be able to join
- male and female
- age more than 18
- patient underwent hip or knee arthroplasty
Who cannot join
- age less than 18
- comorbidity that can results in the difficulty to come back for the follow up
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
Istituto Ortopedico Galeazzi
Milan, 20161
michele ulivi, Dr, 00390266214946, micheleulivi@msn.com
About this study
Official title: Patient-Reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty in Galeazzi Orthopaedic Institute Milano
Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis, Prosthesis Survival
- Being tested
- arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroplastyProcedure or surgery
patient with hip and knee osteoarthritis underwent hip and knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| patient underwent hip and knee arthroplasty | Patients with hip and knee osteoarthritis underwent hip and knee arthroplasty included in inclusion criteria. Receives: Procedure: arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome measurements
improve evaluation of hip and knee arthroplasty monitoring patient reported outcome measurements before and after surgery.
Measured: pre operative to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start12 Jan 2016
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Prospective
- Enrolment
- 5,816 participants (estimated)
- Target duration
- 10 Years
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
- NCT04960098
- Sponsor's protocol ID
- PROMS
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty in Galeazzi Orthopaedic Institute Milano
- ClinicalTrials.gov ID
- NCT04960098
- Acronym / sponsor ID
- PROMS
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis, Prosthesis Survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,816 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 13 Jul 2021 (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.
Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient underwent hip and knee arthroplasty | – | Procedure: arthroplastyPatients with hip and knee osteoarthritis underwent hip and knee arthroplasty included in inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients underwent hip and knee arthroplasty included in inclusion criteria
Key inclusion criteria (3 listed)
- male and female
- age more than 18
- patient underwent hip or knee arthroplasty
Key exclusion criteria (2 listed)
- age less than 18
- comorbidity that can results in the difficulty to come back for the follow up
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 |
|---|---|---|
| arthroplastypatient with hip and knee osteoarthritis underwent hip and knee arthroplasty | Procedure or surgery | patient underwent hip and knee arthroplasty |
Primary outcome
outcome measurements
Time frame: pre operative to 10 years
improve evaluation of hip and knee arthroplasty monitoring patient reported outcome measurements before and after surgery.
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 19 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 Hip Osteoarthritis 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 3 inclusion and 2 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 19 Jul 2021. 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 Michele Ulivi (00390266214946, micheleulivi@masn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome measurements (time frame: pre operative to 10 years). 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 19 Jul 2021.