Proximal Humerus Surgery in Covid Recovered PatientsNCT06506006
A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study
An observational study of Proximal Humerus Surgery in Covid Recovered Patients, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Proximal Humerus Surgery in Covid Recovered Patients
- What is being tested?
- Covid infection
- How many people
- 78 participants
- Where
- 1 siteNepal
- Study dates
- 1 Apr 2020to 30 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- isolated traumatic proximal humerus fracture (Neer's grading 3 and 4)
- above 18 years of age
- consenting for the study
Who cannot join
- open fractures: Gustilo Grade II and III
- neurovascular compromise.
- neuromuscular disorders.
- injury severity score >16
- humerus fracture with extension to shaft
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Covid infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid infectionBiological
outcome with and without covid infection
| Study group | Role | What they receive |
|---|---|---|
| post COVID | patients with proximal humerus fracture with concommitant COVID postive status receiving delayed treatment Receives: Biological: Covid infection | |
| Non COVIID | patients with proximal humerus fracture without concommitant COVID postive status receiving usual treatment Receives: Biological: Covid infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Apr 2020
- Primary completion30 Mar 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus Surgery in Covid Recovered PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashbin bhattarai, B.P. Koirala Institute of Health Sciences
- Investigators
- ashbin bhattarai, masters, Principal investigator, National Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506006
- Sponsor's protocol ID
- 306/077/078-IRC
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the results will be shared which includes the mean score and p values between groups
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Early Outcome of Surgical Management of Proximal Humerus Fracture in Adults During COVID-19 Pandemic- A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06506006
- Acronym / sponsor ID
- 306/077/078-IRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post COVID | – | Biological: Covid infectionpatients with proximal humerus fracture with concommitant COVID postive status receiving delayed treatment |
| Non COVIID | – | Biological: Covid infectionpatients with proximal humerus fracture without concommitant COVID postive status receiving usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- isolated traumatic proximal humerus fracture (Neer's grading 3 and 4)
- above 18 years of age
- consenting for the study
Key exclusion criteria (5 listed)
- open fractures: Gustilo Grade II and III
- neurovascular compromise.
- neuromuscular disorders.
- injury severity score >16
- humerus fracture with extension to shaft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Covid infectionoutcome with and without covid infection | Biological | Non COVIID, post COVID |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No. only the results will be shared which includes the mean score and p values between groups
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ashbin bhattarai, masters principal investigator
National Trauma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humerus Surgery in Covid Recovered Patients, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neer's shoulder score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.