Evaluation of Shoulder Strength and Deltoid Stiffness After Reverse Shoulder Arthroplasty (RSA)

NCT06222281 | Completed

• 1 other identifier: Elastography RSA
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to test the strength of the shoulder joint and elasticity of the deltoid muscle of the patients who had a reverse shoulder arthroplasty. The main questions are: • Whether there is a difference between the operated and healthy shoulders in terms of strength and deltoid elasticity of the patients. • Is there any correlation between the functional status, elasticity and strength of the operated shoulder? Participants will be asked to attend the isokinetic shoulder strength tests and shear wawe ultrasound elastography measurements. They will be also asked to fill the quick DASH and Constant score forms.

Conditions

Sonoelastography; Isokinetic Test

Keywords

elastography; Deltoid; shoulder strength; reverse shoulder arthroplasty

Outcome Measures

Primary Outcomes (8)

• shear wave elastography (SWE)

  SWE provides an indirect measure of a tissue's mechanical properties by quantifying the speed at which sound waves propagate through soft tissue. Shear wave elastography will be carried out once for both shoulders before the isokinetic tests

  Through study completion, an average of 8 weeks

• shoulder adduction strength

  adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit

  Through study completion, an average of 8 weeks

• shoulder adduction endurance

  endurance strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 180 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit.

  Through study completion, an average of 8 weeks

• modified Constant shoulder outcome score

  Patients will fill the constant score questionnaire to evaluate the functional status of operated shoulder. The modified Constant score will be used to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function

  It will be carried out once for each patient, through study completion, an average of 8 weeks

• American Shoulder Elbow Surgeons (ASES) orthopedic score

  The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.

  It will be carried out once for each patient, through study completion, an average of 8 weeks

• Quick shoulder disabilities arm shoulder and hand questionnaire (QuickDASH)

  Patients will fill the quick disabilities of the arm, shoulder, and hand outcome measure questionnaire (the quick-DASH) to evaluate the functional status of operated shoulder.his questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.t is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.

  It will be carried out once for each patient, through study completion, an average of 8 weeks

• shoulder abduction endurance

  to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynamometer, results will be presented in newton metre (nm) unit

  Through study completion, an average of 8 weeks

• shoulder abduction strength

  adduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit

  Through study completion, an average of 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were operated in the university hospital, department of orthopedics and traumatology

You may qualify if:

• Having undergone reverse shoulder arthroplasty surgery due to arthropathy because of unilateral rotator cuff tear
• Followed for at least 12 months after surgery.
• The other unoperated shoulder is healthy.

You may not qualify if:

• Patients with revision reverse shoulder arthroplasty
• Having inflammatory diseases
• Not having adequate range of motion to be able to perform isokinetic test

Sponsors & Collaborators

• Şensu Dinçer: lead

Study Sites (1)

Şensu Dinçer

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 24, 2024
• Study Start: May 20, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 25, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)