- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Bologna, Italien, 40136
- Istituto Ortopedico Rizzoli
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
Patients undergone hip or knee replacement for osteoarthritis
Exclusion Criteria:
Patients undergone hip or knee replacement for fracture, trauma or oncological diseases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
early independence
Tidsramme: 5 days after surgery
|
The recovery of patients of the independence measured by ILOA score
|
5 days after surgery
|
|
early ambulation
Tidsramme: during hospitalization
|
The first time that the patient is able to walk with elbow crutches after surgery
|
during hospitalization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
early upstairs
Tidsramme: during hospitalization
|
The first time that the patient is able to upstairs after surgery
|
during hospitalization
|
|
Wound infection
Tidsramme: during hospitalization
|
Incidence of wound infection
|
during hospitalization
|
|
Urinary infections
Tidsramme: during hospitalization
|
Incidence of urinary infection
|
during hospitalization
|
|
Pressure ulcers
Tidsramme: during hospitalization
|
Incidence of pressure ulcers
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during hospitalization
|
|
Paralytic ileus
Tidsramme: during hospitalization
|
diagnosis or sign of paralytic ileus
|
during hospitalization
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Codice AVEC 352/2021/Oss/IOR
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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