Covid19PTA/PTGCovidNCT04883788
The Impact of COVID-19 Pandemic on Hip and Knee Replacement
An observational study of Covid19 and Hip Arthropathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Hip Arthropathy, Knee Arthropathy
- What is being tested?
- Pandemic period
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 10 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undegone hip or knee replacement for osteoarthrits during 2020
Who may be able to join
- Patients undergone hip or knee replacement for osteoarthritis
Who cannot join
- Patients undergone hip or knee replacement for fracture, trauma or oncological diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19, Hip Arthropathy, Knee Arthropathy
- Being tested
- Pandemic period
- Keywords
- Covid19 pandemic, Hip Arthropathy, Knee Arthropathy, Nursing Sensitive Outcome, Rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic periodOther
Perioperative care (nursing and physiotherapy) provided to patients treated with hip and knee replacement during the pandemic period
| Study group | Role | What they receive |
|---|---|---|
| Pandemic group | Patients undergone hip and knee replacement during pandemic period (June-december 2020) Receives: Other: Pandemic period | |
| Pre-pandemic group | Patients undergone hip and knee replacement during the pre-pandemic period (january-march 2020) |
What is being measured
The primary outcome is the main question the study is designed to answer.
early independence
The recovery of patients of the independence measured by ILOA score
Measured: 5 days after surgery
early ambulation
The first time that the patient is able to walk with elbow crutches after surgery
Measured: during hospitalization
Secondary outcomes (5)
early upstairs
The first time that the patient is able to upstairs after surgery
Measured: during hospitalization
Wound infection
Incidence of wound infection
Measured: during hospitalization
Urinary infections
Incidence of urinary infection
Measured: during hospitalization
Pressure ulcers
Incidence of pressure ulcers
Measured: during hospitalization
Paralytic ileus
diagnosis or sign of paralytic ileus
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 May 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattia Morri, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883788
- Sponsor's protocol ID
- Codice AVEC 352/2021/Oss/IOR
- Acronym
- PTA/PTGCovid
- Status last verified
- Jan 2022
- First submitted
- 11 May 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28626086Randau 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.
PubMed 32898179Wong 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.
PubMed 32675668Macey 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.
PubMed 33215132Shields 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.
PubMed 7870749
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04883788
- Acronym / sponsor ID
- PTA/PTGCovid / Codice AVEC 352/2021/Oss/IOR
- Conditions
- Covid19, Hip Arthropathy, Knee Arthropathy
- Keywords
- Covid19 pandemic, Hip Arthropathy, Knee Arthropathy, Nursing Sensitive Outcome, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemic group | – | Other: Pandemic periodPatients undergone hip and knee replacement during pandemic period (June-december 2020) |
| Pre-pandemic group | – | –Patients undergone hip and knee replacement during the pre-pandemic period (january-march 2020) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undegone hip or knee replacement for osteoarthrits during 2020
Key inclusion criteria (1 listed)
- Patients undergone hip or knee replacement for osteoarthritis
Key exclusion criteria (1 listed)
- Patients undergone hip or knee replacement for fracture, trauma or oncological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pandemic periodPerioperative care (nursing and physiotherapy) provided to patients treated with hip and knee replacement during the pandemic period | Other | Pandemic group |
Primary outcome
early independence
Time frame: 5 days after surgery
The recovery of patients of the independence measured by ILOA score
early ambulation
Time frame: during hospitalization
The first time that the patient is able to walk with elbow crutches after surgery
5 secondary outcomes
early upstairs
Time frame: during hospitalization
Wound infection
Time frame: during hospitalization
Urinary infections
Time frame: during hospitalization
Pressure ulcers
Time frame: during hospitalization
Paralytic ileus
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 28626086Aiken 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.
- Background: PubMed 32898179Randau 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.
- Background: PubMed 32675668Wong 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.
- Background: PubMed 33215132Macey 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.
- Background: PubMed 7870749Shields 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Hip Arthropathy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early independence (time frame: 5 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883788, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.