A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study

July 16, 2024 updated by: ashbin bhattarai, B.P. Koirala Institute of Health Sciences

The goal of this observational study is to learn the outcome of proximal humerus fracture surgery in patients who had it delayed due to COVID infection and compare it with normal patients with same fracture and treatment. The main question it aims to answer is:

• Do the patients with proximal humerus fracture undergoing delayed fixation secondary to COVID infection have the same outcome as that of the normal patients?

The outcome of patients of both group will be assessed objectively via the standard Neer"s shoulder score and compared using independent variable T test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Koshi
      • Dharān Bāzār, Koshi, Nepal, 56700
        • B.P.Koirala Insitute of Helath Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

both group included patients with isolated traumatic proiximal humerus fracture. The post COVID group included patients with tested COVID positive at presentation. The Non COVID group wire non infected population without COVID infection

Description

Inclusion Criteria:

  • isolated traumatic proximal humerus fracture (Neer's grading 3 and 4)
  • above 18 years of age
  • consenting for the study

Exclusion Criteria:

  • open fractures: Gustilo Grade II and III
  • neurovascular compromise.
  • neuromuscular disorders.
  • injury severity score >16
  • humerus fracture with extension to shaft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
post COVID
patients with proximal humerus fracture with concommitant COVID postive status receiving delayed treatment
Biological: Covid infection
outcome with and without covid infection
Non COVIID
patients with proximal humerus fracture without concommitant COVID postive status receiving usual treatment
Biological: Covid infection
outcome with and without covid infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neer's shoulder score
Time Frame: 6 months
functional scoring that includes combined score of range of motion, pain, function and anatomy, maximum score of 100 and minimum of 0 and higher score means better result
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Principal Investigator: ashbin bhattarai, masters, National Trauma Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306/077/078-IRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

only the results will be shared which includes the mean score and p values between groups

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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