The Effects of Different Surgical Stabilization Methods in Recurrent Anterior Shoulder Instability

NCT ID: NCT06154460

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-06-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. Conservative and surgical treatments of instability are available. There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported.Therefore, the aim of this study was to compare different surgical stabilization methods in terms of pain, proprioceptive sensation, functional status and muscle activation in recurrent anterior shoulder instability, which is very common in adults.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. It is more common in young males. While damage is limited to the capsule and labrum in most instabilities seen in young people, rotator cuff tear is also observed in 89% of those over 40 years of age. Trauma is the main cause of shoulder instability. While 96% of shoulder instabilities develop as a result of a blow to the arm in abduction or external rotation of the shoulder with excessive flexion, approximately 4% occur without trauma. Anterior instability occurs when the shoulder is forced into abduction and external rotation by impact, and posterior instability occurs when the shoulder in slight flexion and adduction is hit. The glenohumeral joint is an unstable joint because the depth and size of the glenoid fossa are not fully compatible with the humerus and as a result, the range of motion is wider compared to other joints in the body. While articular surface congruence, articular version, glenoid labrum, capsule and ligaments constitute static factors in ensuring stability; rotator cuff, biceps tendon, intra-articular negative pressure and muscles that form scapulothoracic movements (Trapezoid, Serratus Anterior, Rhomboids, Latissimus Dorsi) constitute dynamic factors. Insufficiency of one or more of these structures causes instability. Conservative and surgical treatments of instability are available. Conservative treatment includes nonoperative methods. These methods consist of electrophysical agents, heat-light agents, exercise and manual treatment methods and proceed through a certain protocol according to the patient's condition and symptoms. In cases where medical and physical therapies are not sufficient, surgical treatment procedures are initiated.

Reimplisasagge, capsular reconstruction and laterjet methods are commonly used in surgical treatments. Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect. The possibility of loss of internal and external rotation as a result of infraspinatus tendon transfer after reimplissage is a matter of debate. Allografts or autografts are used for capsular reconstruction, which is another surgical method. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted. The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.

There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported. Therefore, the aim of our study was to compare these commonly applied methods in terms of pain, proprioceptive sensation, functional status and muscle activation and the hypothesis of the study was as follows; Hypothesis of the Study: Laterjet, reimplissage and capsular reconstruction surgical procedures in recurrent anterior shoulder instabilities affect pain, proprioceptive sensation, functional status and muscle activation differently.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Anterior Shoulder Instability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laterjet Surgery Group

This group will consist of individuals who underwent laterjet surgery.

Laterjet Surgery

Intervention Type PROCEDURE

The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.

Reimplissage Surgery Group

This group will consist of individuals who underwent reimplissage surgery.

Reimplissage Surgery

Intervention Type PROCEDURE

Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect.

Capsular Reconstruction Surgery Group

This group will consist of individuals who underwent capsular reconstruction surgery.

Capsular Reconstruction

Intervention Type PROCEDURE

Allografts or autografts are used for capsular reconstruction. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laterjet Surgery

The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.

Intervention Type PROCEDURE

Reimplissage Surgery

Reimplissagge operation, which means "to fill", is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect.

Intervention Type PROCEDURE

Capsular Reconstruction

Allografts or autografts are used for capsular reconstruction. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LS RS CR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older,
* At least 4 months after surgery,
* Not having any diagnosed neurological problem

Exclusion Criteria

* Having an additional diagnosis that would cast doubt on the assessments (rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric disorders, etc.),
* Pregnancy status or suspicion
* Having undergone a different surgery such as a fracture with instability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ferruh Taşpınar

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mustafa Özkan, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Betul Taspinar, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Izmir Democracy University

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SSM-SI-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Results of Rotator Cuff Repair
NCT01549912 COMPLETED