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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

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

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

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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Istituto Ortopedico Galeazzi
    Milano, 20161, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

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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