- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06870721
Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation
March 6, 2025 updated by: Mohamed hussein khalil, Cairo University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Giza, Cairo, Egypt
- Faculty of medicine, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation
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
|
arthroscopic dynamic anterior stabilization transferring long head of biceps to the anterior glenoid in patients with recurrent anterior shoulder dislocation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline, and 2 years postoperative
|
|
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
|
baseline, and 2 years postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mohamed H khalil, M.D, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Collin 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.
- de 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.
- Milenin 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
October 31, 2024
Study Completion (Actual)
October 31, 2024
Study Registration Dates
First Submitted
March 6, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-208-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.