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

NCT04960098 | Recruiting

• 1 other identifier: PROMS
• Study Type: observational
• Target: 5,816
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis; Prosthesis Survival

Outcome Measures

Primary Outcomes (1)

• outcome measurements

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

  pre operative to 10 years

Study Arms (1)

patient underwent hip and knee arthroplasty

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

Procedure: arthroplasty

Interventions

arthroplasty PROCEDURE

patient with hip and knee osteoarthritis underwent hip and knee arthroplasty

patient underwent hip and knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients underwent hip and knee arthroplasty included in inclusion criteria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Prosthesis Failure

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Michele Ulivi

CONTACT

00390266214946; micheleulivi@masn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: January 12, 2016
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

IT (1)