NCT04882670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

February 16, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of urinary infections

    through hospitalization, an average of 9 days

  • Number of accidental falls

    through hospitalization, an average of 9 days

  • Start day for walking

    through hospitalization, an average of 9 days

  • Level of independence

    5 days after surgery

Study Arms (1)

hip fracture

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hip fracture patients who are admitted to the emergency room of an orthopedic university hospital

You may qualify if:

  • Patients diagnosed with fragility hip fracture such as pertrochanteric fracture, femoral neck fracture and subtrochanteric fracture
  • Age 65 or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Conditions

Hip FracturesCOVID-19

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2021

First Posted

May 12, 2021

Study Start

February 1, 2021

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations