COVID-19 Pandemic on Health Care and Rehabilitation Outcomes

Covid19 Clinical Trial

— HIP COVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882670
• Other study ID #: 0001531
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: July 31, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Hip Fractures

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pressure ulcer	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)	through hospitalization, an average of 9 days
Secondary	Incidence of urinary infections	positive urine-culture test report	through hospitalization, an average of 9 days
Secondary	Number of accidental falls	The incidence of falls during the hospitalization	through hospitalization, an average of 9 days
Secondary	Start day for walking	The first time the patient is able to walk	through hospitalization, an average of 9 days
Secondary	Level of independence	ILOA scale, ranged from 0 to 50; 0 is the better level of independence and 50 the worse level of independence.	5 days after surgery