Clinical trial NCT06870721: Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation
Official title: Long Head of Biceps as an Anterior Dynamic Sling for Recurrent Anterior Shoulder Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Dynamic anterior stabilization; onlay; glenohumeral instability.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case series of 25 patients
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: rowe score
timeFrame: baseline, and 2 years postoperative
measure: Quick Disabilities of Arm, Shoulder and Hand
timeFrame: baseline, and 2 years postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Medicine, Cairo University
state: Cairo
Study officials:
affiliation: Cairo University
name: mohamed H khalil, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.