An interventional study of Arthroscopic Dynamic Anterior Stabilization and Arthroscopic Bankart Repair in Surgeons, Shoulder Instability and Bankart Lesions, sponsored by Riga Stradins University. Recruiting at 1 site in Latvia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Riga Stradins University · Not applicable, Interventional, and Treatment
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
Health condition(s) or problem(s) studied Recurrent Anterior Shoulder (glenohumeral) Instability with subcritical glenoid bone loss (10- 20%.
Interventions Intervention 1: Arthroscopic Bankart Repair Arthroscopic repair of the anterior capsulolabral complex using suture anchors to restore anterior glenohumeral stability.
Intervention 2: Dynamic Anterior Stabilization (DAS) Arthroscopic dynamic anterior stabilization using the long head of the biceps tendon to augment the anterior labrum and provide additional dynamic stabilization of the glenohumeral joint.
This was a single-center, prospective comparative clinical study. Patients presenting with complaints of recurrent anterior shoulder instability were prospectively screened for eligibility according to clinical and radiological criteria and selected for the study.
All patients underwent preoperative magnetic resonance imaging (MRI) for the assessment of soft-tissue injuries and computed tomography (CT) for the evaluation of glenoid bone loss.
30 patients underwent dynamic anterior stabilization (DAS group), whereas 30 patients underwent isolated Bankart repair (Bankart group), which is the control group. Group allocation was performed using a computer program.
Surgical Procedures and Tissue Sampling All surgical procedures were performed arthroscopically by one surgeon. Intraoperative tissue specimens were obtained from both groups for subsequent histopathological examination. In the DAS group, a bone specimen was collected from the anterior glenoid surface together with a segment of the long head of the biceps tendon. In the Bankart group, specimens were obtained from the anterior glenoid bone surface and the anterior labrum. All specimens were processed according to the same standardized histopathological protocol.
Ethics Approval and Informed Consent The study was conducted in accordance with the principles in the Declaration of Helsinki and the Oviedo Convention. Ethical approval was obtained from Riga Stradins University (No. 2-PEK-4/694/2024, 29 November 2024).
Written informed consent was obtained from all participants before enrollment in the study.
If random allocation, the trial is reported according to CONSORT and provides the registration information. The journal also requires an ICMJE-recognized registry, the original protocol, and this document is an unpublished CONSORT checklist as supplementary files.
Operative time and the requirement for additional postoperative analgesic medication were also recorded.
Preview, not for official use. All patients underwent the same standardized postoperative rehabilitation protocol regardless of treatment allocation. Histopathological Examination All collected tissue specimens were fixed in 10% neutral-buffered formalin and embedded in paraffin. Bone core biopsies obtained from the anterior glenoid measured approximately 6-8 mm in length, whereas soft-tissue specimens (both LHB and Labrum) measured approximately 8-12 mm. Sections of 3 μm thickness were prepared and stained with hematoxylin and eosin.
Histopathological assessment of the soft-tissue specimens included evaluation of inflammatory cell infiltration. The number of inflammatory cells, including lymphocytes and leukocytes, was assessed in ten high-power fields at x400 magnification and expressed as cells per mm3.
Bone tissue histomorphometry was performed according to the 2012 update of the American Society for Bone and Mineral Research (ASBMR) Histomorphometry Nomenclature Committee recommendations. The assessed parameters included core length, tissue area, bone area, and bone volume. Osteonecrosis was defined by the presence of bone trabeculae containing empty osteocyte lacunae, and the results were expressed as the percentage of necrotic bone trabeculae.
Peritrabecular fibrosis was graded using a four-point scale: grade 0, regular bone trabeculae with distinct paratrabecular borders; grade 1, focal budding, hooks, spikes, or paratrabecular apposition of new bone; grade 2, diffuse paratrabecular new bone formation with thickening of the trabeculae and occasional focal interconnections; and grade 3, extensive interconnected new bone formation with substantial effacement of the marrow spaces. Statistical Analysis: Categorical and non-parametric data were analyzed using the Chi-square test and the Mann-Whitney U test, respectively. Correlations between the clinical or histopathological variables were evaluated using the Pearson Chi-square (χ2) test. A p-value of \<0.05 was considered statistically significant. The GraphPad Prism 12 software was used for data analysis.
Riga Stradins University is the lead sponsor of 19 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo arthroscopic dynamic anterior stabilization using the long head of the biceps tendon.
Procedure: Arthroscopic Dynamic Anterior Stabilization
Participants undergo arthroscopic Bankart repair using suture anchors.
Procedure: Arthroscopic Bankart Repair
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
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
Recurrent anterior shoulder instability
Number/proportion of patients experiencing postoperative redislocation and/or symptomatic subluxation.
Time frame: Up to 24 months after surgery
American Shoulder and Elbow Surgeons (ASES) score.
Shoulder function is evaluated using the ASES score, ranging from 0 to 100, with higher scores indicating better shoulder function.
Time frame: Baseline, 1, 3, 6, 12, 24 months postoperatively.
Constant - Murley Score
Shoulder function is evaluated using the Constant - Murley Score, including pain, activities of daily living, range of motion, and strength. Ranging from 0 to 100 points, where higher scores indicate better shoulder function
Time frame: Baseline, 1, 3, 6, 12, 24 months postoperatively.
Visual Analogue Scale (VAS)
Shoulder pain will be assessed with the Visual Analogue Scale (VAS), where higher scores indicate greater pain intensity. Ranging from 0 to 10 points.
Time frame: Baseline, 1, 3, 6, 12, 24 months postoperatively.
Return to sport and work
The proportion of patients returning to their previous level of sporting activity and/or work and the time required to return will be recorded.
Time frame: 1, 3, 6, 12, 24 months postoperatively.
Revision surgery
The number and proportion of patients requiring additional surgical treatment because of recurrent instability, persistent symptoms, or complications will be recorded.
Time frame: 24 months after the index procedure.
Postoperative complications
Surgical and postoperative complications, including infection, stiffness, neurological complications, persistent pain, implant-related complications, and other adverse events, will be recorded.
Time frame: 24 - month follow-up after procedure.
Surgery time
The duration of surgery will be measured in minutes.
Time frame: From the start to completion of the surgical procedure
Postoperative medication use
The type, duration, and amount of postoperative analgesic and anti-inflammatory medication will be recorded and compared between the DAS and Bankart groups.
Time frame: 1, 3, 6, 12, 24 months postoperatively.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — It is sensetive data of each patient
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Bankart Lesions
Riga Stradins University