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

NCT06506006 | Completed

• 1 other identifier: 306/077/078-IRC
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proximal Humerus Surgery in Covid Recovered Patients

Outcome Measures

Primary Outcomes (1)

• neer's shoulder score

  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

Study Arms (2)

post COVID

patients with proximal humerus fracture with concommitant COVID postive status receiving delayed treatment

Biological: Covid infection

Non COVIID

patients with proximal humerus fracture without concommitant COVID postive status receiving usual treatment

Biological: Covid infection

Interventions

Covid infection BIOLOGICAL

outcome with and without covid infection

Non COVIID; post COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B.P.Koirala Insitute of Helath Sciences

Dharān, Koshi, 56700, Nepal

Location

Study Officials

• ashbin bhattarai, masters

  National Trauma Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 17, 2024
• Study Start: April 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: January 30, 2022
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)