Proximal Humeral FracturesNCT06659107
Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture
A study testing Closed reduction and fixation by K- wires in people with Proximal Humeral Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Proximal Humeral Fractures
- What is being tested?
- Closed reduction and fixation by K- wires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2023to 6 Sep 2024
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes
- Age from 60 to80 years
- 2 or 3 parts fracture
- recent injury less than 3 weeks
Who cannot join
- 4 parts fracture
- old injury more than 3 weeks
- previous surgeries or pathologies affecting shoulder range of motion
Trial locations and contacts
1 site in 1 country.
About this study
This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures
- Conditions
- Proximal Humeral Fractures
- Being tested
- Closed reduction and fixation by K- wires
- Keywords
- Proximal humeral fractures, Mutual linking
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed reduction and fixation by K- wiresProcedure or surgery
Fixation by k-wires with mutual linking technique
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with proximal humeral fractures Neer type 2 and 3 | Experimental | Both sexes, age from 60 to 80 Receives: Procedure: Closed reduction and fixation by K- wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Shoulder functional status using the American shoulder and elbow surgeons score (ASES) range from 0 to100, 0 being the worst and 100 being the best
Measured: One year
Radiological outcome
The percentage of patients achieving union of the fracture assesed by plain X-ray shoulder anteroposterior and lateral views.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start6 Sep 2023
- Primary completion12 Jul 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FracturesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Maher, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659107
- Sponsor's protocol ID
- proximal humeral fracture
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Kirschner Wires With Mutual Linking Technique in the Management of Proximal Humeral Fracture
- ClinicalTrials.gov ID
- NCT06659107
- Acronym / sponsor ID
- proximal humeral fracture
- Conditions
- Proximal Humeral Fractures
- Keywords
- Proximal humeral fractures, Mutual linking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 26 Oct 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.
This is study evaluates a novel technique to improve the stability of K-wires used in the fixation of proximal humeral fractures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with proximal humeral fractures Neer type 2 and 3 | Experimental | Procedure: Closed reduction and fixation by K- wiresBoth sexes, age from 60 to 80 |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- both sexes
- Age from 60 to80 years
- 2 or 3 parts fracture
- recent injury less than 3 weeks
Key exclusion criteria (3 listed)
- 4 parts fracture
- old injury more than 3 weeks
- previous surgeries or pathologies affecting shoulder range of motion
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 |
|---|---|---|
| Closed reduction and fixation by K- wiresFixation by k-wires with mutual linking technique | Procedure or surgery | Elderly patients with proximal humeral fractures Neer type 2 and 3 |
Primary outcome
Functional outcome
Time frame: One year
Shoulder functional status using the American shoulder and elbow surgeons score (ASES) range from 0 to100, 0 being the worst and 100 being the best
Radiological outcome
Time frame: 8 weeks
The percentage of patients achieving union of the fracture assesed by plain X-ray shoulder anteroposterior and lateral views.
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 26 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed reduction and fixation by K- wires in people with Proximal Humeral Fractures, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 3 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 26 Oct 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 Egypt. 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?
Functional outcome (time frame: One year). The study lists 2 primary outcomes in all. 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 26 Oct 2024.