Shoulder DislocationNCT06870721
Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation
A study testing arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation in people with Shoulder Dislocation, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: To evaluate the functional outcomes of arthroscopic onlay dynamic anterior stabilization (DAS) using the long head of biceps (LHB) tendon for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL). Read more about this study
- Who is it for?
- Ages 20 to 32 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 31 Oct 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 20 to 32 years
- All sexes
- No healthy volunteers
- Adult
The inclusion criteria were
- Patients complaining of AGI, with one or more events of anterior shoulder dislocation.
- Associated limited (<13.5%) to subcritical (<25%) GBL.
- Positive anterior shoulder apprehension.
The exclusion criteria were
- Associated critical GBL (≥25%).
- Concomitant LHB lesion or rupture.
- Multidirectional or voluntary shoulder instability.
- Prior arthroscopic shoulder stabilization procedure.
- Concomitant rotator cuff tears.
- Acute proximal humerus fractures of the involved shoulder.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To evaluate the functional outcomes of arthroscopic onlay dynamic anterior stabilization (DAS) using the long head of biceps (LHB) tendon for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL).
Read the detailed description
Twenty-five patients underwent arthroscopic DAS using LHB between March 2022 and October 2022 for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL) were included in a prospective study with a minimum follow-up period of 2 years. The shoulder functional outcomes were assessed using the Rowe and the Quick Disabilities of Arm, Shoulder and Hand (Quick DASH) scores both preoperative and at 2 years follow-up. Magnetic resonance imaging (MRI) at 6 months after surgery to evaluate LHB tendon healing to the anterior glenoid.
- Conditions
- Shoulder Dislocation
- Being tested
- arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation
- Keywords
- Dynamic anterior stabilization; onlay; glenohumeral instability.
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocationProcedure or surgery
arthroscopic dynamic anterior stabilization transferring long head of biceps to the anterior glenoid in patients with recurrent anterior shoulder dislocation
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation | Experimental | arthroscopic dynamic anterior stabilization using Long head of biceps as for recurrent anterior shoulder dislocation arthroscopic transfer of the Long head of biceps to the anterior glenoid inpatients with recurrent shoulder dislocation Receives: Procedure: arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rowe score
shoulder score, the maximum is 100, the minimum is zero, the higher score means a better outcome
Measured: baseline, and 2 years postoperative
Quick Disabilities of Arm, Shoulder and Hand
shoulder score, the maximum is 100, the minimum is zero, the higher score means a worse outcome
Measured: baseline, and 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Mar 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- case series of 25 patients
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed hussein khalil, Cairo University
- Investigators
- mohamed H khalil, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870721
- Sponsor's protocol ID
- N-208-2024
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu C, Xu J, Fang Z, Chen J, Ye Z, Wang L, Kang Y, Zhao S, Xu C, Zhao J. Arthroscopic Dynamic Anterior Stabilization Using Either Long Head of the Biceps or Conjoined Tendon Transfer for Anterior Shoulder Instability Results in a Similarly Low Recurrence Rate. Arthroscopy. 2023 Jul;39(7):1618-1627. doi: 10.1016/j.arthro.2022.12.040. Epub 2023 Jan 25.
PubMed 36708745Collin P, Nabergoj M, Denard PJ, Wang S, Bothorel H, Ladermann A. Arthroscopic Biceps Transfer to the Glenoid With Bankart Repair Grants Satisfactory 2-Year Results for Recurrent Anteroinferior Glenohumeral Instability in Subcritical Bone Loss. Arthroscopy. 2022 Jun;38(6):1766-1771. doi: 10.1016/j.arthro.2021.11.043. Epub 2021 Dec 7.
PubMed 34883198de Campos Azevedo C, Angelo AC. Onlay Dynamic Anterior Stabilization With Biceps Transfer for the Treatment of Anterior Glenohumeral Instability Produces Good Clinical Outcomes and Successful Healing at a Minimum 1 Year of Follow-Up. Arthrosc Sports Med Rehabil. 2023 Feb 23;5(2):e445-e457. doi: 10.1016/j.asmr.2023.01.012. eCollection 2023 Apr.
PubMed 37101880Milenin O, Toussaint B. Labral Repair Augmentation by Labroplasty and Simultaneous Trans-Subscapular Transposition of the Long Head of the Biceps. Arthrosc Tech. 2019 Apr 26;8(5):e507-e512. doi: 10.1016/j.eats.2019.01.010. eCollection 2019 May.
PubMed 31194141
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation
- ClinicalTrials.gov ID
- NCT06870721
- Acronym / sponsor ID
- N-208-2024
- Conditions
- Shoulder Dislocation
- Keywords
- Dynamic anterior stabilization; onlay; glenohumeral instability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Mar 2025 (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.
Purpose: To evaluate the functional outcomes of arthroscopic onlay dynamic anterior stabilization (DAS) using the long head of biceps (LHB) tendon for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL).
Detailed description
Twenty-five patients underwent arthroscopic DAS using LHB between March 2022 and October 2022 for treatment of anterior glenohumeral instability (AGI) with limited to subcritical glenoid bone loss (GBL) were included in a prospective study with a minimum follow-up period of 2 years. The shoulder functional outcomes were assessed using the Rowe and the Quick Disabilities of Arm, Shoulder and Hand (Quick DASH) scores both preoperative and at 2 years follow-up. Magnetic resonance imaging (MRI) at 6 months after surgery to evaluate LHB tendon healing to the anterior glenoid.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case series of 25 patients
| Arm | Type | Receives |
|---|---|---|
| arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation | Experimental | Procedure: arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocationarthroscopic dynamic anterior stabilization using Long head of biceps as for recurrent anterior shoulder dislocation arthroscopic transfer of the Long head of biceps to the anterior glenoid inpatients with recurrent shoulder dislocation |
Who may qualify
- Ages
- 20 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocationarthroscopic dynamic anterior stabilization transferring long head of biceps to the anterior glenoid in patients with recurrent anterior shoulder dislocation | Procedure or surgery | arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation |
Primary outcome
rowe score
Time frame: baseline, and 2 years postoperative
shoulder score, the maximum is 100, the minimum is zero, the higher score means a better outcome
Quick Disabilities of Arm, Shoulder and Hand
Time frame: baseline, and 2 years postoperative
shoulder score, the maximum is 100, the minimum is zero, the higher score means a worse outcome
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 11 Mar 2025.
- Background: PubMed 36708745Wu C, Xu J, Fang Z, Chen J, Ye Z, Wang L, Kang Y, Zhao S, Xu C, Zhao J. Arthroscopic Dynamic Anterior Stabilization Using Either Long Head of the Biceps or Conjoined Tendon Transfer for Anterior Shoulder Instability Results in a Similarly Low Recurrence Rate. Arthroscopy. 2023 Jul;39(7):1618-1627. doi: 10.1016/j.arthro.2022.12.040. Epub 2023 Jan 25.
- Background: PubMed 34883198Collin P, Nabergoj M, Denard PJ, Wang S, Bothorel H, Ladermann A. Arthroscopic Biceps Transfer to the Glenoid With Bankart Repair Grants Satisfactory 2-Year Results for Recurrent Anteroinferior Glenohumeral Instability in Subcritical Bone Loss. Arthroscopy. 2022 Jun;38(6):1766-1771. doi: 10.1016/j.arthro.2021.11.043. Epub 2021 Dec 7.
- Background: PubMed 37101880de Campos Azevedo C, Angelo AC. Onlay Dynamic Anterior Stabilization With Biceps Transfer for the Treatment of Anterior Glenohumeral Instability Produces Good Clinical Outcomes and Successful Healing at a Minimum 1 Year of Follow-Up. Arthrosc Sports Med Rehabil. 2023 Feb 23;5(2):e445-e457. doi: 10.1016/j.asmr.2023.01.012. eCollection 2023 Apr.
- Background: PubMed 31194141Milenin O, Toussaint B. Labral Repair Augmentation by Labroplasty and Simultaneous Trans-Subscapular Transposition of the Long Head of the Biceps. Arthrosc Tech. 2019 Apr 26;8(5):e507-e512. doi: 10.1016/j.eats.2019.01.010. eCollection 2019 May.
- 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.
mohamed H khalil, M.D principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation in people with Shoulder Dislocation, run by Cairo 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?
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 11 Mar 2025. 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?
rowe score (time frame: baseline, and 2 years postoperative). 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?
On the ClinicalTrials.gov record for NCT06870721, which also lists 4 linked publications.
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 11 Mar 2025.