Skip to main content
OpenTrials
Completed

NCT Number: NCT04882670

COVID-19 Pandemic on Health Care and Rehabilitation Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of pressure ulcer

    Time frame: 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 outcomes

  1. Incidence of urinary infections

    Time frame: through hospitalization, an average of 9 days

    positive urine-culture test report

  2. Number of accidental falls

    Time frame: through hospitalization, an average of 9 days

    The incidence of falls during the hospitalization

  3. Start day for walking

    Time frame: through hospitalization, an average of 9 days

    The first time the patient is able to walk

  4. Level of independence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: HIP COVID

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.