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

NCT06154460 | Completed

• 1 other identifier: SSM-SI-35
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Anterior Shoulder Instability

Keywords

Joint Instability; Shoulder Joint; Orthopedic Procedurs; Shoulder Pain; Proprioception; Functional Status; Electromyography

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

Laterjet Surgery Group

This group will consist of individuals who underwent laterjet surgery.

Procedure: Laterjet Surgery

Reimplissage Surgery Group

This group will consist of individuals who underwent reimplissage surgery.

Procedure: Reimplissage Surgery

Capsular Reconstruction Surgery Group

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

Procedure: Capsular Reconstruction

Interventions

Laterjet Surgery PROCEDURE

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

Also known as: LS

Laterjet Surgery Group

Reimplissage Surgery 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.

Also known as: RS

Reimplissage Surgery Group

Capsular Reconstruction 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

Also known as: CR

Capsular Reconstruction Surgery Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The sample of the study will consist of individuals who have undergone surgery in the Department of Orthopedics and Traumatology of Dokuz Eylül University Hospital due to instability diagnosis and who have returned to their activities of daily living. The research groups will consist of 30 patients with at least 10 patients each for 3 different surgical methods. These methods will be compared with each other in terms of pain, proprioceptive sensation, functional status and muscle activation. According to the reviewed studies, the number of individuals to be included in the study was determined as 30 individuals in total, 10 in each group.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Instability; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mustafa Özkan, Prof. Dr.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Betul Taspinar, Prof. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: December 4, 2023
• Study Start: December 18, 2023
• Primary Completion: May 10, 2024
• Study Completion: June 29, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)