Clinical trial NCT04883788: The Impact of COVID-19 Pandemic on Hip and Knee Replacement
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Hip Arthropathy
Knee Arthropathy
Keywords: Covid19 pandemic
Hip Arthropathy
Knee Arthropathy
Nursing Sensitive Outcome
Rehabilitation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undegone hip or knee replacement for osteoarthrits during 2020

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.

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.

Eligibility criteria: Inclusion Criteria:

Patients undergone hip or knee replacement for osteoarthritis

Exclusion Criteria:

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

Primary outcomes:
measure: early independence
timeFrame: 5 days after surgery
measure: early ambulation
timeFrame: during hospitalization
Secondary outcomes:
measure: early upstairs
timeFrame: during hospitalization
measure: Wound infection
timeFrame: during hospitalization
measure: Urinary infections
timeFrame: during hospitalization
measure: Pressure ulcers
timeFrame: during hospitalization
measure: Paralytic ileus
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
citation: 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.
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.
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.
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. doi: 10.1093/ptj/75.3.169.