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

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT04883788
Collaborator
(none)
600
1
7.9
76.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pandemic period

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 Design

Study Type:
Observational
Actual Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
May 15, 2021
Actual Primary Completion Date :
Jan 10, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. early independence [5 days after surgery]

    The recovery of patients of the independence measured by ILOA score

  2. early ambulation [during hospitalization]

    The first time that the patient is able to walk with elbow crutches after surgery

Secondary Outcome Measures

  1. early upstairs [during hospitalization]

    The first time that the patient is able to upstairs after surgery

  2. Wound infection [during hospitalization]

    Incidence of wound infection

  3. Urinary infections [during hospitalization]

    Incidence of urinary infection

  4. Pressure ulcers [during hospitalization]

    Incidence of pressure ulcers

  5. Paralytic ileus [during hospitalization]

    diagnosis or sign of paralytic ileus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients undergone hip or knee replacement for osteoarthritis

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Ortopedico Rizzoli Bologna Italy 40136

Sponsors and Collaborators

  • Istituto Ortopedico Rizzoli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mattia Morri, Physiotherapist, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT04883788
Other Study ID Numbers:
  • Codice AVEC 352/2021/Oss/IOR
First Posted:
May 12, 2021
Last Update Posted:
Feb 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mattia Morri, Physiotherapist, Istituto Ortopedico Rizzoli
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022