Patient-reported Outcome Measures in Patient Underwent To... | NCT04960098

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

NCT04960098

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Recruiting

Last Update Posted

Jul 19, 2021Actual

Enrollment

5,816Estimated

Phase

Not provided

Conditions

Hip Osteoarthritis
Knee Osteoarthritis
Prosthesis Survival

Interventions

arthroplasty

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2016Actual

Primary Completion Date

Dec 31, 2050Estimated

Completion Date

Dec 31, 2050Estimated

First Submitted Date

Jul 2, 2021

First Submission Date that Met QC Criteria

Jul 2, 2021

First Posted Date

Jul 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2021

Last Update Posted Date

Jul 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,816Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient underwent hip and knee arthroplasty		Patients with hip and knee osteoarthritis underwent hip and knee arthroplasty included in inclusion criteria.	Procedure: arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arthroplasty	Procedure	patient with hip and knee osteoarthritis underwent hip and knee arthroplasty	patient underwent hip and knee arthroplasty

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients underwent hip and knee arthroplasty included in inclusion criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michele Ulivi	Contact	00390266214946		micheleulivi@masn.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Ortopedico Galeazzi	Recruiting	Milan		20161	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip
D020370	Osteoarthritis, Knee
D011475	Prosthesis Failure

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001178	Arthroplasty

Ancestor Terms

ID	Term
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures

Browse Leaves

Not provided

Browse Branches

Not provided