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RecruitingNCT04960098Updated Jul 19, 2021

Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty

An observational study in Hip Osteoarthritis, Knee Osteoarthritis and Prosthesis Survival, 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, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-19.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,816
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hip Osteoarthritis
  • Knee Osteoarthritis
  • Prosthesis Survival
03

In context

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

This study's planned enrollment of 5,816 is above the median of 135 across 158 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Browse I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients underwent hip and knee arthroplasty included in inclusion criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male and female
  • age more than 18
  • patient underwent hip or knee arthroplasty

Exclusion criteria

Exclusion Criteria:

  • age less than 18
  • comorbidity that can results in the difficulty to come back for the follow up
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,816 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • patient underwent hip and knee arthroplasty

    Patients with hip and knee osteoarthritis underwent hip and knee arthroplasty included in inclusion criteria.

    Procedure: arthroplasty

Interventions

  • Procedurearthroplasty

    patient with hip and knee osteoarthritis underwent hip and knee arthroplasty

06

What researchers measure

Primary outcomes

  1. outcome measurements

    improve evaluation of hip and knee arthroplasty monitoring patient reported outcome measurements before and after surgery.

    Time frame: pre operative to 10 years

07

Study locations

1 of 1 sites recruiting
  • Istituto Ortopedico Galeazzi
    Milano, 20161, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for Dec 2050, 419 months after the start.

Of 52 non-industry observational studies under Osteoarthritis, Hip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's planned 419 months is above that.

Counting every sponsor, half of 81 studies reached it within 53 months; a quarter within 13 and three quarters within 113.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2021
First posted
Jul 13, 2021
StartActual
Jan 12, 2016
Primary completionEst.
Dec 31, 2050
CompletionEst.
Dec 31, 2050
Last update
Jul 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04960098
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Jul 13, 2021
Start date
Jan 12, 2016
Primary completion
Dec 31, 2050 (estimated)
Completion
Dec 31, 2050 (estimated)
Last update
Jul 19, 2021

Study contacts

Michele Ulivi
Contact
micheleulivi@masn.com
00390266214946

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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