The Impact of COVID-19 Pandemic on Hip and Knee Replacement (PTA/PTGCovid)

January 27, 2022 updated by: Mattia Morri, Istituto Ortopedico Rizzoli

The Impact of COVID-19 Pandemic on the Nursing-sensitive and Rehabilitation Outcomes of Patients Undergoing Hip or Knee Replacement: a Single Centre Retrospective Study

During the COVID-19 pandemic, the care of patients undergoing hip or knee replacement for osteoarthritis remains a clinical priority. To date, there is limited empirical knowledge about the impact of pandemic on the care of patients surgically treated for orthopaedic diseases, affected or not by COVID-19.

The aim of the present study is to describe and investigate the effects of the COVID-19 pandemic on the nursing-sensitive and rehabilitation outcomes of patients undergoing hip and knee replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From hospital electronic registry of patients will be possible to screen the patients eligible for the study.

From each electronic patients record, health professional researchers will be responsable to collect data.

Variables about nursing and physiotherapy care, the staffing activities and the outcome achieved by the patients will be collected.

To investigate the impact of COVID-19 pandemic, data of the pandemic period (june-december 2020), will be compared with the data of the same year pre-pandemic (january-march 2020). During the period from april to may 2020, only orthopaedic surgery for emergency trauma or disease was allowed.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients undegone hip or knee replacement for osteoarthrits during 2020

Description

Inclusion Criteria:

Patients undergone hip or knee replacement for osteoarthritis

Exclusion Criteria:

Patients undergone hip or knee replacement for fracture, trauma or oncological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pandemic group
Patients undergone hip and knee replacement during pandemic period (June-december 2020)
Other: Pandemic period
Perioperative care (nursing and physiotherapy) provided to patients treated with hip and knee replacement during the pandemic period
Pre-pandemic group
Patients undergone hip and knee replacement during the pre-pandemic period (january-march 2020)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early independence
Time Frame: 5 days after surgery
The recovery of patients of the independence measured by ILOA score
5 days after surgery
early ambulation
Time Frame: during hospitalization
The first time that the patient is able to walk with elbow crutches after surgery
during hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early upstairs
Time Frame: during hospitalization
The first time that the patient is able to upstairs after surgery
during hospitalization
Wound infection
Time Frame: during hospitalization
Incidence of wound infection
during hospitalization
Urinary infections
Time Frame: during hospitalization
Incidence of urinary infection
during hospitalization
Pressure ulcers
Time Frame: during hospitalization
Incidence of pressure ulcers
during hospitalization
Paralytic ileus
Time Frame: during hospitalization
diagnosis or sign of paralytic ileus
during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Codice AVEC 352/2021/Oss/IOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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