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

Surgery Clinical Trial

— SSM-SI  

Official title:

Comparison of Different Surgical Stabilization Methods for Recurrent Anterior Shoulder Instability in Terms of Pain, Proprioceptive Sense, Functional Status, and Muscle Activation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154460
• Other study ID #: SSM-SI-35
• Status: Not yet recruiting
• Start date: December 18, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: October 2023
• Source: Izmir Democracy University
• Contact: Ferruh Taspinar, Prof. Dr.
• Phone: 05426853877
• Email: fztferruh[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 29, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Shoulder Instability
• Joint Instability
• Surgery

Intervention

Procedure:
• Laterjet Surgery
The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
• 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Democracy University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pain	Pain will be assessed by visual analog scale (VAS). A 10 cm horizontal line will be used for this. '0' means no pain and '10' means the worst possible pain	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of proprioceptive sensation	Positioning test will be used for the evaluation of proprioceptive sensation. Evaluation scores are calculated as the proportion of correct responses for repositioning.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of Range of Motion	A universal goniometer will be used for normal range of motion assessment. The normal limits of active range of motion are considered to be 180° for shoulder flexion, 180° for shoulder abduction, 90° for shoulder external rotation and 70-90° for shoulder internal rotation.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of Hand Grip Strength	Hand grip strength will be assessed with jamar hand dynamometer. In the test procedure, 3 measurements are made for hand grip and finger grip strengths with one-minute intervals between each measurement and the averages are recorded. High values mean high grip strength.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of functional status	DASH (Disability Arm Shoulder and Hand) questionnaire will be used. Each item has 5 response options ranging from 'no difficulty or no symptoms' to 'unable to perform the activity or very severe symptom' and is scored on a scale of 1 to 5 points. A scale score ranging from 0 (no disability) to 100 (most severe disability) is calculated.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of Shoulder Instability	WOSI (Western Ontario Shoulder Instability Index) will be used. The WOSI is a 21-item questionnaire used for patients with shoulder instability. Each question results in a number between 0 and 100 and the total score is presented as a number between 0 and 2100 points.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.
Primary	Assessment of Muscle Activation	Muscle activation will be evaluated by superficial EMG measurements. For this, the muscles with the best reaction around the shoulder joint were selected. These muscles were musculus infraspinatus, musculus middle deltoideus, musculus upper trapezius and musculus pectoralis major. The activation of the muscles will be evaluated during isometric contraction and during isotonic contractions performed in 3 different planes and results will be interpreted according to activation status. Data will be recorded during maximum voluntary isometric contraction (MVIC) and isotonic contraction (IC). During these contacts, the calculated "area" on the chart will be recorded. Additionally, the "IC/MVIC" percentage will be calculated to determine the workload on the muscle during the activity.	Subjects will be evaluated between a post-operative minimum of 4 months and a maximum of 2 years.