NCT04883788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

May 11, 2021

Last Update Submit

January 27, 2022

Conditions

Covid19Hip ArthropathyKnee Arthropathy

Keywords

Covid19 pandemicHip ArthropathyKnee ArthropathyNursing Sensitive OutcomeRehabilitation

Outcome Measures

Primary Outcomes (2)

  • early independence

    The recovery of patients of the independence measured by ILOA score

    5 days after surgery

  • early ambulation

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

    during hospitalization

Secondary Outcomes (5)

  • early upstairs

    during hospitalization

  • Wound infection

    during hospitalization

  • Urinary infections

    during hospitalization

  • Pressure ulcers

    during hospitalization

  • Paralytic ileus

    during hospitalization

Study Arms (2)

Pandemic group

Patients undergone hip and knee replacement during pandemic period (June-december 2020)

Other: Pandemic period

Pre-pandemic group

Patients undergone hip and knee replacement during the pre-pandemic period (january-march 2020)

Interventions

Pandemic periodOTHER

Perioperative care (nursing and physiotherapy) provided to patients treated with hip and knee replacement during the pandemic period

Pandemic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undegone hip or knee replacement for osteoarthrits during 2020

You may qualify if:

  • Patients undergone hip or knee replacement for osteoarthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

  • Aiken LH, Sloane D, Griffiths P, Rafferty AM, Bruyneel L, McHugh M, Maier CB, Moreno-Casbas T, Ball JE, Ausserhofer D, Sermeus W; RN4CAST Consortium. Nursing skill mix in European hospitals: cross-sectional study of the association with mortality, patient ratings, and quality of care. BMJ Qual Saf. 2017 Jul;26(7):559-568. doi: 10.1136/bmjqs-2016-005567. Epub 2016 Nov 15.

    PMID: 28626086BACKGROUND

  • Randau TM, Jaenisch M, Haffer H, Schomig F, Kasapovic A, Olejniczak K, Flechtenmacher J, Perka C, Wirtz DC, Pumberger M. Collateral effect of COVID-19 on orthopedic and trauma surgery. PLoS One. 2020 Sep 8;15(9):e0238759. doi: 10.1371/journal.pone.0238759. eCollection 2020.

    PMID: 32898179BACKGROUND

  • Wong JSH, Cheung KMC. Impact of COVID-19 on Orthopaedic and Trauma Service: An Epidemiological Study. J Bone Joint Surg Am. 2020 Jul 15;102(14):e80. doi: 10.2106/JBJS.20.00775.

    PMID: 32675668BACKGROUND

  • Macey ARM, Butler J, Martin SC, Tan TY, Leach WJ, Jamal B. 30-day outcomes in hip fracture patients during the COVID-19 pandemic compared to the preceding year. Bone Jt Open. 2020 Nov 2;1(7):415-419. doi: 10.1302/2633-1462.17.BJO-2020-0077.R1. eCollection 2020 Jul.

    PMID: 33215132BACKGROUND

  • Shields RK, Enloe LJ, Evans RE, Smith KB, Steckel SD. Reliability, validity, and responsiveness of functional tests in patients with total joint replacement. Phys Ther. 1995 Mar;75(3):169-76; discussion 176-9. doi: 10.1093/ptj/75.3.169.

    PMID: 7870749BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 12, 2021

Study Start

May 15, 2021

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)