Shoulder InjuriesNCT06186362
Results of Distal Clavicle Graft in Shoulder Dislocation Clavicle Auto Graft in Patient With Recurrent Anterior Shoulder Dislocation
An observational study of Shoulder Injuries, run by Al-Azhar University.
Trial summary
to evaluate the clinical and radiological Outcome of Distal Clavicle Auto graft in patient with recurrent Shoulder dislocation Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Shoulder Injuries
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2025
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Range of motion "ROM" (Forward flexion, external rotation, internal rotation) Preoperative and postoperative ROM . Rowe score, Visual analogue score (VAS). Secondary outcomes postoperative complications will be evaluated.
Who may be able to join
- Recurrent Traumatic anterior shoulder dislocation (≥ 3 times).
Who cannot join
- .On-track Hill-Sachs lesion. .Multi directional instability.
- Voluntary dislocation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiological Results of Distal Clavicle Auto Graft in Patient With Recurrent Anterior Shoulder Dislocation
to evaluate the clinical and radiological Outcome of Distal Clavicle Auto graft in patient with recurrent Shoulder dislocation
Read the detailed description
The glenohumeral joint is the most commonly dislocated joint of the human body,The stability of GH joint relies on a complex network of static and dynamic structures,The anterior labrum plays a key role in antero posterior stability as it deepens the glenoid cavity up to 50% There option for glenoid reconstruction including: Distal Clavicle Auto graft (DCA), proven is a good option to coracoid transfers
- Conditions
- Shoulder Injuries
- Medical subject headings
- Shoulder Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Row score
Rang of motion
Measured: At 2 months, 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
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 Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Khalaf Mahmoud Mohammed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186362
- Sponsor's protocol ID
- DCRSD
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kane P, Bifano SM, Dodson CC, Freedman KB. Approach to the treatment of primary anterior shoulder dislocation: A review. Phys Sportsmed. 2015 Feb;43(1):54-64. doi: 10.1080/00913847.2015.1001713. Epub 2015 Jan 6.
PubMed 25559018
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Results of Distal Clavicle Auto Graft in Patient With Recurrent Anterior Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT06186362
- Acronym / sponsor ID
- DCRSD
- Conditions
- Shoulder Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 2 Jan 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.
to evaluate the clinical and radiological Outcome of Distal Clavicle Auto graft in patient with recurrent Shoulder dislocation
Detailed description
The glenohumeral joint is the most commonly dislocated joint of the human body,The stability of GH joint relies on a complex network of static and dynamic structures,The anterior labrum plays a key role in antero posterior stability as it deepens the glenoid cavity up to 50% There option for glenoid reconstruction including: Distal Clavicle Auto graft (DCA), proven is a good option to coracoid transfers
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Range of motion "ROM" (Forward flexion, external rotation, internal rotation) Preoperative and postoperative ROM . Rowe score, Visual analogue score (VAS). Secondary outcomes postoperative complications will be evaluated.
Key inclusion criteria (1 listed)
- Recurrent Traumatic anterior shoulder dislocation (≥ 3 times).
Key exclusion criteria (2 listed)
- .On-track Hill-Sachs lesion. .Multi directional instability.
- Voluntary dislocation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Row score
Time frame: At 2 months, 6 months post operative
Rang of motion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 25559018Kane P, Bifano SM, Dodson CC, Freedman KB. Approach to the treatment of primary anterior shoulder dislocation: A review. Phys Sportsmed. 2015 Feb;43(1):54-64. doi: 10.1080/00913847.2015.1001713. Epub 2015 Jan 6.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries, run by Al-Azhar University.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosam Elsayed Abd-Elzaher, Lecturer (+201008832805, Hosamortho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Row score (time frame: At 2 months, 6 months post operative). 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 NCT06186362, 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 5 Jan 2024.