- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04883788
The Impact of COVID-19 Pandemic on Hip and Knee Replacement (PTA/PTGCovid)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Bologna, Italië, 40136
- Istituto Ortopedico Rizzoli
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
Patients undergone hip or knee replacement for osteoarthritis
Exclusion Criteria:
Patients undergone hip or knee replacement for fracture, trauma or oncological diseases
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Pandemic group
Patients undergone hip and knee replacement during pandemic period (June-december 2020)
|
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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
early independence
Tijdsspanne: 5 days after surgery
|
The recovery of patients of the independence measured by ILOA score
|
5 days after surgery
|
|
early ambulation
Tijdsspanne: during hospitalization
|
The first time that the patient is able to walk with elbow crutches after surgery
|
during hospitalization
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
early upstairs
Tijdsspanne: during hospitalization
|
The first time that the patient is able to upstairs after surgery
|
during hospitalization
|
|
Wound infection
Tijdsspanne: during hospitalization
|
Incidence of wound infection
|
during hospitalization
|
|
Urinary infections
Tijdsspanne: during hospitalization
|
Incidence of urinary infection
|
during hospitalization
|
|
Pressure ulcers
Tijdsspanne: during hospitalization
|
Incidence of pressure ulcers
|
during hospitalization
|
|
Paralytic ileus
Tijdsspanne: during hospitalization
|
diagnosis or sign of paralytic ileus
|
during hospitalization
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Codice AVEC 352/2021/Oss/IOR
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .