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

NCT ID: NCT06222281

Last Updated: 2025-11-18

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

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-06-25

Brief Summary

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

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.

Detailed Description

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

The ultrasound elastography is a measurement method that has become increasingly common recently and can measure some mechanical properties of tissue. Measurements can be made using two different techniques: strain and shear wave elastography (SWEUS). SWEUS provides objective and reproducible data collection about the elasticity of the tissue and is less affected by the user than the strain technique. The mechanical properties of the deltoid muscle are among the main factors affecting surgical results in patients undergoing reverse shoulder replacement surgery. Glenohumeral joint function is affected by the post-operative tension of the deltoid. Excessive tension in the deltoid muscle may cause restriction of movement and pain, as well as conditions such as instability and insufficient force production. Lack of elasticity of deltoid muscle may also lead to functional deficit of shoulder. Previous studies have found a linear correlation between muscle activity and muscle elasticity values measured by MR elastography (MRE). However, MRE is an expensive method that requires large equipment and space, and it is a more difficult method for patients, which may include various difficulties in patient positioning. Ultrasound elastography is a method that is highly investigated for clinical use because it is cheaper and easier to apply than MRE. Isokinetic dynamometer is one of the most objective methods used to measure muscle activity and strength.Thus, it is imperative to reveal the mechanical properties of deltoid muscle, which carries the most of the mechanical load in the shoulder region after the operation, as well as the relationship between them.

The medical history of patients who had undergone reverse prosthesis surgery in the Department of Orthopedics and Traumatology, and their postoperative files will be screened. Patients who meet the inclusion and exclusion criteria will be invited to the study.

Their demographic information will be recorded. The visual pain scale (VAS) and will be questioned to evaluate the pain status. Functional status of the patients, and the patients will be asked to complete the Constant score and the quick arm, shoulder and hand problems questionnaire (Q-DASH) under supervision. They will be asked to answer. Shear wave elastographic measurement and isokinetic tests of both shoulders will be carried out in the sports medicine department. Measurement outcomes of both shoulders will be compared.

Conditions

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

Sonoelastography Isokinetic Test

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

CROSS_SECTIONAL

Eligibility Criteria

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

Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

Şensu Dinçer

OTHER

Sponsor Role lead

Responsible Party

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

Şensu Dinçer

medical doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Şensu Dinçer

Istanbul, , 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.

Elastography RSA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Subscap Reverse Shoulder Arthroplasty
NCT05344898 RECRUITING NA