NCT06870721

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

March 6, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

Dynamic anterior stabilization; onlay; glenohumeral instability.

Outcome Measures

Primary Outcomes (2)

  • rowe score

    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

    shoulder score, the maximum is 100, the minimum is zero, the higher score means a worse outcome

    baseline, and 2 years postoperative

Study Arms (1)

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

Procedure: arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation

Interventions

arthroscopic dynamic anterior stabilization transferring long head of biceps to the anterior glenoid in patients with recurrent anterior shoulder dislocation

arthroscopic dynamic anterior stabilization for recurrent anterior shoulder dislocation

Eligibility Criteria

Age20 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Giza, Cairo Governorate, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 36708745BACKGROUND
  • 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.

    PMID: 34883198BACKGROUND
  • 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.

    PMID: 37101880BACKGROUND
  • 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.

    PMID: 31194141BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Study Officials

  • mohamed H khalil, M.D

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case series of 25 patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 11, 2025

Study Start

March 1, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations