HIP COVID: COVID-19 Pandemic on Health Care and Rehabilitation Outcomes

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT04882670
Collaborator
(none)
360
1
5.9
60.9

Study Details

Study Description

Brief Summary

Fragility fracture is easily associated with a clinical worsening of patients in terms of quality of life and disability in the medium and long term. Following this traumatic event, more than half of the patients are unable to recover pre-fracture motor skills such as the ability to walk. The impact of the COVID-19 pandemic on this type of patient has not been described and it is easy to hypothesize that, given their intrinsic frailty condition, they may have been significantly affected by changes in care pathways.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The global health emergency due to the spread of COVID-19 has caused unprecedented pressure on the health systems of the various countries involved. COVID-19 has had a direct impact on the health status of people with an extremely high number of ICU admissions and deaths, but it has also led to a series of equally strong indirect consequences as described in various fields by multiple authors. In order to cope with the great health demand linked to the epidemic, hospitals had to invest human and physical resources, subtracting them from other care activities: operating theaters, surgical and non-surgical departments and the related staff normally destined for patient care were redirected and relocated to the care of COVID patients.

    In the field of orthopedic surgery in the first phase of the spread of the epidemic, all non-essential interventions have been postponed and for essential interventions specific paths have been created at hospitals capable of operating even during the pandemic. This organization has led to a reduction in the overall number of hospitalized patients but the number of old patients operated for hip fracture has not decreased. From the point of view of the impact of the COVID-19 pandemic on all patients operated for hip fracture with respect to the care outcomes during the postoperative hospital stay, the available data are lacking.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    360 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Impact of the COVID-19 Pandemic on Health Care and Rehabilitation Outcomes in Frail Patients With a Hip Fracture. A Retrospective Prognostic Study
    Actual Study Start Date :
    Feb 1, 2021
    Actual Primary Completion Date :
    Jul 30, 2021
    Actual Study Completion Date :
    Jul 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    hip fracture

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of pressure ulcer [through hospitalization, an average of 9 days]

      The lesions were described according to the site of onset and classified by severity categories in accordance with the guide drawn up by the National Pressure Ulcer Advisory Panel - N.P.U.A.P. (NPUAP, EPUAP, & PPPIA, 2019)

    Secondary Outcome Measures

    1. Incidence of urinary infections [through hospitalization, an average of 9 days]

      positive urine-culture test report

    2. Number of accidental falls [through hospitalization, an average of 9 days]

      The incidence of falls during the hospitalization

    3. Start day for walking [through hospitalization, an average of 9 days]

      The first time the patient is able to walk

    4. Level of independence [5 days after surgery]

      ILOA scale, ranged from 0 to 50; 0 is the better level of independence and 50 the worse level of independence.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients diagnosed with fragility hip fracture such as pertrochanteric fracture, femoral neck fracture and subtrochanteric fracture

    • Age 65 or older

    Exclusion Criteria:
    • Patients diagnosed with a fragility hip fracture whose nursing record was not scanned at the time of the investigation

    • Patients with fragility fractures of the diaphyseal and / or distal femur and acetabular fractures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS Istituto Ortopedico Rizzoli Bologna BO Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT04882670
    Other Study ID Numbers:
    • 0001531
    First Posted:
    May 12, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2021