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SurgeonsNCT07876232

Comparison of Surgical Techniques for Anterior Shoulder Instability

A study testing Arthroscopic Dynamic Anterior Stabilization and Arthroscopic Bankart Repair in people with Surgeons and Shoulder Instability, run by Riga Stradins University at 1 site in Latvia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%). Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Surgeons, Shoulder Instability, Bankart Lesions
What is being tested?
Arthroscopic Dynamic Anterior Stabilization and Arthroscopic Bankart Repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteLatvia
Study dates
1 Nov 2024to 31 Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrejs Finogejevs, M.D. contact

+37129951841

andrejs.finogejevs@inbox.lv

Latvia1 site, 1 recruiting
  • ORTO Klīnika

    Riga

    Recruiting

Other trials in Latvia

About this study

Official title: Comparative Outcomes of Arthroscopic Surgical Techniques in Anterior Shoulder Instability With Glenoid Bone Loss 10-20%

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.

Read more

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

Read the detailed description

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.

Being tested
Arthroscopic Dynamic Anterior Stabilization, Arthroscopic Bankart Repair
Medical subject headings
Bankart Lesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic Dynamic Anterior StabilizationProcedure or surgery

    Also called DAS, Shoulder anterior stabilization

    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.

  • Arthroscopic Bankart RepairProcedure or surgery

    Also called Bankart, Labrum glenoidale fixation

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

Study groups in NCT07876232
Study groupRoleWhat they receive
Dynamic Anterior Stabilization (DAS) - surgical procedureExperimentalParticipants undergo arthroscopic dynamic anterior stabilization using the long head of the biceps tendon.
Receives: Procedure: Arthroscopic Dynamic Anterior Stabilization
Arthroscopic Bankart Repair - surgical procedureActive comparatorParticipants undergo arthroscopic Bankart repair using suture anchors.
Receives: Procedure: Arthroscopic Bankart Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent anterior shoulder instability

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

    Measured: Up to 24 months after surgery

Secondary outcomes (8)
  1. 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.

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

  2. 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

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

  3. 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.

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

  4. 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.

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

  5. Revision surgery

    The number and proportion of patients requiring additional surgical treatment because of recurrent instability, persistent symptoms, or complications will be recorded.

    Measured: 24 months after the index procedure.

  6. Postoperative complications

    Surgical and postoperative complications, including infection, stiffness, neurological complications, persistent pain, implant-related complications, and other adverse events, will be recorded.

    Measured: 24 - month follow-up after procedure.

  7. Surgery time

    The duration of surgery will be measured in minutes.

    Measured: From the start to completion of the surgical procedure

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2026
  2. Study start1 Nov 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07876232
Sponsor's protocol ID
2-PEK-4/694/2024
Status last verified
Nov 2025
First submitted
4 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is sensetive data of each patient

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic Dynamic Anterior Stabilization and Arthroscopic Bankart Repair in people with Surgeons and Shoulder Instability, run by Riga Stradins University at 1 site in Latvia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrejs Finogejevs, M.D. (+37129951841, andrejs.finogejevs@inbox.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent anterior shoulder instability (time frame: Up to 24 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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