Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage

NCT07892729 | Active Not Recruiting DMC

• 1 other identifier: 10082026DASHSR
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate clinical, functional, and magnetic resonance imaging (MRI) outcomes after arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) in patients with recurrent anterior glenohumeral instability. The main questions it aims to answer are:

• How much does the Western Ontario Shoulder Instability Index (WOSI) change from before surgery to a minimum of 2 years after DAS-LHB?
• What is the structural integrity and healing status of the transferred long head of the biceps tendon on routine postoperative MRI obtained at least 6 months after surgery?
• What are the postoperative rates of recurrent instability, reoperation, residual apprehension, return to sport, and changes in shoulder function and range of motion? Researchers will also compare patients who underwent isolated DAS-LHB with patients who underwent DAS-LHB combined with Hill-Sachs remplissage to explore whether the addition of remplissage is associated with differences in clinical, functional, and imaging outcomes. This comparison is exploratory and was not randomized. Participants underwent surgery as part of routine clinical care and will not receive any additional treatment or imaging for research purposes. Researchers will review existing clinical records and imaging studies. If routine follow-up data are incomplete, some participants may be contacted by telephone, secure electronic questionnaire, or clinical review to complete standardized outcome assessment.

Conditions

Anterior Shoulder Instability

Keywords

Dynamic Anterior Stabilization; DAS-LHB; Long Head of the Biceps; Anterior Shoulder Instability; Glenohumeral Instability; Hill-Sachs Lesion; Remplissage; Shoulder Arthroscopy; Glenoid Bone Loss; Bipolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario Shoulder Instability Index (WOSI) score

  The Western Ontario Shoulder Instability Index (WOSI) is a patient-reported outcome measure specific to shoulder instability. The total score ranges from 0 to 2100, with lower scores indicating better shoulder-related quality of life and fewer symptoms. The primary outcome is the within-participant change in WOSI score from the preoperative assessment to the final follow-up assessment.

  From preoperative baseline to a minimum of 24 months after surgery

Secondary Outcomes (8)

• Change in Rowe score

  From Preoperative baseline to a minimum of 24 months after surgery

• Change in shoulder range of motion

  From Preoperative baseline to a minimum of 24 months after surgery

• Recurrent anterior shoulder instability

  From index surgery to final follow-up, minimum 24 months

• Positive anterior apprehension test

  At final follow-up, minimum 24 months after surgery

• Structural integrity and healing of the transferred long head of the biceps tendon on MRI

  Postoperative MRI obtained at least 6 months after surgery

Study Arms (2)

Group/Cohort 1 - Earlier DAS-LHB Cohort

Consecutive patients treated during the earlier treatment era with arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) without Hill-Sachs remplissage.

Procedure: Arthroscopic Onlay Dynamic Anterior Stabilization Using the Long Head of the Biceps Tendon (DAS-LHB)

Group/Cohort 2 - DAS-LHB Plus Remplissage Cohort

Consecutive patients treated during the subsequent treatment era with arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) combined with Hill-Sachs remplissage when clinically indicated.

Procedure: Arthroscopic Onlay Dynamic Anterior Stabilization Using the Long Head of the Biceps Tendon (DAS-LHB); Procedure: Hill-Sachs Remplissage

Interventions

Arthroscopic Onlay Dynamic Anterior Stabilization Using the Long Head of the Biceps Tendon (DAS-LHB) PROCEDURE

Arthroscopic transfer of the intra-articular portion of the long head of the biceps tendon through a subscapularis split with fixation in an onlay position on the anterior glenoid using all-suture anchors, performed as part of routine clinical care.

Group/Cohort 1 - Earlier DAS-LHB Cohort; Group/Cohort 2 - DAS-LHB Plus Remplissage Cohort

Hill-Sachs Remplissage PROCEDURE

Arthroscopic fixation of the posterior capsule and infraspinatus tendon into the Hill-Sachs defect using one all-suture anchor, performed in selected patients according to the surgical team's clinical indication algorithm.

Group/Cohort 2 - DAS-LHB Plus Remplissage Cohort

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients treated by the same two-surgeon shoulder team for recurrent anterior glenohumeral instability using arthroscopic DAS-LHB, with or without Hill-Sachs remplissage, during the defined study period. The cohort includes an earlier treatment-era group treated with isolated DAS-LHB and a subsequent treatment-era group treated with DAS-LHB plus remplissage when clinically indicated.

You may qualify if:

• Age 15 years or older at the time of surgery
• Arthroscopic dynamic anterior stabilization using the long head of the biceps tendon (DAS-LHB) performed for recurrent anterior glenohumeral instability
• Index surgery performed between June 2018 and December 2026
• At least 24 months elapsed since the index surgery at the time of clinical outcome assessment
• For MRI-based analyses: availability of a routine postoperative shoulder MRI obtained at least 6 months after the index procedure

You may not qualify if:

• Multidirectional instability or posterior-dominant instability as the primary indication for surgery
• Prior bone-block procedure on the index shoulder
• Concomitant rotator cuff repair
• Concomitant fracture fixation
• Neurologic injury affecting the operated upper limb
• Insufficient clinical documentation to establish the primary outcome
• For MRI-based analyses only: non-diagnostic postoperative MRI
• For MRI-based analyses only: postoperative MRI not performed because of a clinical contraindication or patient non-attendance

Sponsors & Collaborators

• Omniartro Lda: lead

Study Sites (1)

Hospital dos SAMS de Lisboa

Lisbon, Europe, 1800, Portugal

Location

Related Publications (3)

• 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: 37101880 RESULT

• de Campos Azevedo C, Angelo AC. Onlay Dynamic Anterior Stabilization of the Shoulder With the Biceps Augmented by Hill-Sachs Remplissage for On- and Off-Track Lesions. Arthrosc Tech. 2025 Jul 25;14(9):103768. doi: 10.1016/j.eats.2025.103768. eCollection 2025 Sep.

  PMID: 41132262 RESULT

• de Campos Azevedo C, Angelo AC. All-Suture Anchor Dynamic Anterior Stabilization Produced Successful Healing of the Biceps Tendon: A Report of 3 Cases. JBJS Case Connect. 2021 Feb 17;11(1). doi: 10.2106/JBJS.CC.20.00149.

  PMID: 33599463 RESULT

MeSH Terms

Conditions

Bankart Lesions

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Officials

• Clara Azevedo

  Hospital dos SAMS de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: June 14, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)