Greater Tuberosity FracturesNCT05403879
Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
A study testing fixation of greater tuberosity fractures in people with Greater Tuberosity Fractures, run by Mansoura University at 1 site in Egypt.
Trial summary
the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Greater Tuberosity Fractures
- What is being tested?
- fixation of greater tuberosity fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2022to 30 Dec 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.
Who cannot join
- Skeletally immature patients (less than 18 years), age more than 50 years.
- Open and pathological fractures
- Associated proximal humeral fractures
- History of previous GH dislocations
- History of previous shoulder injuries or surgeries
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35511
About this study
the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.
Read the detailed description
after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.
- Conditions
- Greater Tuberosity Fractures
- Being tested
- fixation of greater tuberosity fractures
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of greater tuberosity fracturesProcedure or surgery
deltopectoral approach for shoulder, then open reduction and fixation of displaced greater tuberosity fractures using hooked Kirshner wires
| Study group | Role | What they receive |
|---|---|---|
| cases undergoing fixation of fractured greater tuberosity | Experimental | Not described Receives: Procedure: fixation of greater tuberosity fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score
postoperative assessing pain, range of motion, function of shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition
Measured: at least one year follow up
Secondary outcomes (1)
healing time
estimate time till radiological healing on follow-up radiographs
Measured: anticipated 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start23 Mar 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Greater Tuberosity FracturesStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Elshahhat, MD., Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403879
- Sponsor's protocol ID
- R.22.03.1644
- Status last verified
- Jan 2024
- First submitted
- 31 May 2022
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elshahhat A, Nour K. Modified Hook Wiring Technique for Greater Tuberosity Fractures: A Prospective Study. Acta Orthop Belg. 2025 Jun;91(2):209-220. doi: 10.52628/91.2.13849.
PubMed 40878734
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study
- ClinicalTrials.gov ID
- NCT05403879
- Acronym / sponsor ID
- R.22.03.1644
- Conditions
- Greater Tuberosity Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 3 Jun 2022 (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 purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.
Detailed description
after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases undergoing fixation of fractured greater tuberosity | Experimental | Procedure: fixation of greater tuberosity fractures |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.
Key exclusion criteria (5 listed)
- Skeletally immature patients (less than 18 years), age more than 50 years.
- Open and pathological fractures
- Associated proximal humeral fractures
- History of previous GH dislocations
- History of previous shoulder injuries or surgeries
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 |
|---|---|---|
| fixation of greater tuberosity fracturesdeltopectoral approach for shoulder, then open reduction and fixation of displaced greater tuberosity fractures using hooked Kirshner wires | Procedure or surgery | cases undergoing fixation of fractured greater tuberosity |
Primary outcome
functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score
Time frame: at least one year follow up
postoperative assessing pain, range of motion, function of shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition
1 secondary outcome
healing time
Time frame: anticipated 2-4 months
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 3 Jan 2024.
- Derived from this study: PubMed 40878734Elshahhat A, Nour K. Modified Hook Wiring Technique for Greater Tuberosity Fractures: A Prospective Study. Acta Orthop Belg. 2025 Jun;91(2):209-220. doi: 10.52628/91.2.13849.
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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 fixation of greater tuberosity fractures in people with Greater Tuberosity Fractures, run by Mansoura 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 1 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 3 Jan 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 using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score (time frame: at least one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05403879, which also lists 1 linked publication.
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 3 Jan 2024.