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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis; Prosthesis Survival
• Intervention / Treatment: Procedure: arthroplasty

• Study Type: Observational
• Enrollment (Anticipated): 5816

Contacts and Locations

• Study Contact: Name: Michele Ulivi; Phone Number: 00390266214946; Email: micheleulivi@masn.com

Study Locations

• Italy
  • Milano, Italy, 20161
    • Recruiting
    • Istituto Ortopedico Galeazzi
    • Contact: michele ulivi, Dr; Phone Number: 00390266214946; Email: micheleulivi@msn.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients underwent hip and knee arthroplasty included in inclusion criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient underwent hip and knee arthroplasty; Patients with hip and knee osteoarthritis underwent hip and knee arthroplasty included in inclusion criteria.	Procedure: arthroplasty; patient with hip and knee osteoarthritis underwent hip and knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
outcome measurements	improve evaluation of hip and knee arthroplasty monitoring patient reported outcome measurements before and after surgery.	pre operative to 10 years

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2016
• Primary Completion (Anticipated): December 31, 2050
• Study Completion (Anticipated): December 31, 2050

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Prosthesis Failure
• Other Study ID Numbers: PROMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No