Comparison of Surgical Techniques for Anterior Shoulder Instability

NCT07876232 | Recruiting

• 1 other identifier: 2-PEK-4/694/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives Primary Objective To compare the clinical and functional outcomes of arthroscopic Bankart repair and Dynamic Anterior Stabilization (DAS) in patients with chronic anterior shoulder instability and subcritical glenoid bone loss (10-20%). Secondary Objectives To evaluate postoperative shoulder stability, recurrence of instability, functional outcomes, complications, and return to daily and sports activities following the two surgical techniques. To assess the relationship between the extent of glenoid bone loss and postoperative clinical and functional outcomes. To identify clinical and morphological factors associated with postoperative outcomes and recurrence of anterior shoulder instability. We evaluate every patient at 1 month, 3 months, 6 months, 12 months, and 24 months. For evaluation, the Constant Shoulder Score, ASES Score, Visual Analog pain scale, and Oxford instability score

Conditions

Surgeons; Shoulder Instability; Bankart Lesions; Bankart Repair; Dynamic Stability

Outcome Measures

Primary Outcomes (1)

• Recurrent anterior shoulder instability

  Number/proportion of patients experiencing postoperative redislocation and/or symptomatic subluxation.

  Up to 24 months after surgery

Secondary Outcomes (8)

• American Shoulder and Elbow Surgeons (ASES) score.

  Baseline, 1, 3, 6, 12, 24 months postoperatively.

• Constant - Murley Score

  Baseline, 1, 3, 6, 12, 24 months postoperatively.

• Visual Analogue Scale (VAS)

  Baseline, 1, 3, 6, 12, 24 months postoperatively.

• Return to sport and work

  1, 3, 6, 12, 24 months postoperatively.

• Revision surgery

  24 months after the index procedure.

Study Arms (2)

Dynamic Anterior Stabilization (DAS) - surgical procedure

EXPERIMENTAL

Participants undergo arthroscopic dynamic anterior stabilization using the long head of the biceps tendon.

Procedure: Arthroscopic Dynamic Anterior Stabilization

Arthroscopic Bankart Repair - surgical procedure

ACTIVE COMPARATOR

Participants undergo arthroscopic Bankart repair using suture anchors.

Procedure: Arthroscopic Bankart Repair

Interventions

Arthroscopic Dynamic Anterior Stabilization PROCEDURE

Dynamic Anterior Stabilization (DAS) Arthroscopic stabilization of the anterior glenohumeral joint using the long head of the biceps tendon. The tendon is transferred through the subscapularis tendon and fixed to the anterior glenoid, providing dynamic anterior stabilization and augmentation of the anterior capsulolabral complex.

Also known as: DAS, Shoulder anterior stabilization

Dynamic Anterior Stabilization (DAS) - surgical procedure

Arthroscopic Bankart Repair PROCEDURE

Arthroscopic stabilization of the anterior glenohumeral joint by repair and reattachment of the detached anterior capsulolabral complex to the glenoid rim using suture anchors.

Also known as: Bankart, Labrum glenoidale fixation

Arthroscopic Bankart Repair - surgical procedure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged ≤50 years;
• History of anterior shoulder dislocation and/or subluxation;
• Persistent anterior glenohumeral instability;
• MRI-confirmed anterior labral injury and Hill-Sachs lesion;
• CT-confirmed glenoid bone loss of 10-20% of the total glenoid articular surface.

You may not qualify if:

• Patients aged \>50 years;
• Concomitant injuries or pathological conditions involving other structures of the shoulder joint;
• Multidirectional shoulder instability;
• Previous surgical procedures on the affected shoulder;
• Acute infection;
• Coagulation disorders;
• Systemic diseases, including diabetes mellitus (DM), rheumatoid arthritis (RA), gout, and autoimmune diseases (AIDs).

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

ORTO Klīnika

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Bankart Lesions

Interventions

amsonic acid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrejs Finogejevs, M.D.

CONTACT

+37129951841; andrejs.finogejevs@inbox.lv

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Doctor's assitant is evalueted patient every time (Blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Researcher, Department of Orthopaedics; Head of Study Programme Specialisation, Department of Residency; Doctoral student

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 15, 2026
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: October 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)