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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04883788
Other study ID # Codice AVEC 352/2021/Oss/IOR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2021
Est. completion date January 10, 2022

Study information

Verified date January 2022
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date January 10, 2022
Est. primary completion date January 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

Randau TM, Jaenisch M, Haffer H, Schömig 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary early independence The recovery of patients of the independence measured by ILOA score 5 days after surgery
Primary early ambulation The first time that the patient is able to walk with elbow crutches after surgery during hospitalization
Secondary early upstairs The first time that the patient is able to upstairs after surgery during hospitalization
Secondary Wound infection Incidence of wound infection during hospitalization
Secondary Urinary infections Incidence of urinary infection during hospitalization
Secondary Pressure ulcers Incidence of pressure ulcers during hospitalization
Secondary Paralytic ileus diagnosis or sign of paralytic ileus during hospitalization
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