NCT07183774

Brief Summary

Sarcopenia is the loss of muscle mass due to aging, which consequently leads to a decline in muscle function. It is considered an independent risk factor for falls and fractures, disability, postoperative complications, and mortality. Rotator cuff tears are known to be influenced by systemic diseases such as diabetes, hypercholesterolemia, thyroid disorders, and osteoporosis. The aim of our study is to investigate whether there is a relationship between sarcopenia and rotator cuff tears, and if so, to determine the location and type of the tear.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

September 14, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Rotator cuff syndromeRotator cuff tearSarcopenia

Outcome Measures

Primary Outcomes (1)

  • STAR value

    Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method. In this method, gait speed, handgrip strength (measured with a dynamometer), and the chair stand test will first be conducted. For gait speed, a 6-meter walking track will be used, and patients will be instructed to walk at their normal pace. The time will be recorded with a stopwatch, and each patient will perform the test three times, with the average recorded in meters per second (m/s). Subsequently, anterior thigh muscle thickness will be measured using ultrasonography. Based on this comprehensive evaluation, patients will be categorized as non-sarcopenic, pre-sarcopenic, or sarcopenic.

    Baseline

Secondary Outcomes (1)

  • Radiologic evaluation of shoulder MRI

    Baseline

Study Arms (2)

Patients with rotator cuff tear

Patients with parsiyel or full thickness rotator cuff tear in supraspinatus tendon

Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.

Patients without rotator cuff tear

Patients without tear in supraspnatus tendon

Diagnostic Test: Sarcopenia will be assessed using the STAR (Sonographic Thigh Adjustment Ratio) method.

Interventions

A detailed evaluation of shoulder MRI scans will be conducted. The presence and severity of supraspinatus tendon tears, as well as the presence of muscle atrophy (assessed using the tangent sign), will be recorded. In addition, tears in other rotator cuff tendons, signs of tendinitis, and any other pathological findings will also be documented.

Also known as: Shoulder MRIs of patients in each of these three categories will be analyzed to assess the presence, type, and severity of rotator cuff tears.
Patients with rotator cuff tearPatients without rotator cuff tear

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study's target population will be patients aged 40 to 75 who have experienced shoulder pain for longer than three months and who have been physically evaluated and found to have rotator cuff syndrome.

You may qualify if:

  • Patients with rotator cuff syndrome
  • Aged between 40 and 75 years

You may not qualify if:

  • History of previous shoulder surgery
  • Presence of shoulder pathology other than rotator cuff syndrome
  • History of surgical intervention involving the hip or thigh region
  • Being wheelchair-bound or bedridden
  • Presence of an oncologic disease
  • Diagnosis of any neurological disorder
  • Presence of cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Haydarpaşa Numune Research and Training Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Atala NA, Bongiovanni SL, Galich AM, Bruchmann MG, Rossi LA, Tanoira I, Ranalletta M. Is sarcopenia a risk factor for rotator cuff tears? J Shoulder Elbow Surg. 2021 Aug;30(8):1851-1855. doi: 10.1016/j.jse.2020.10.001. Epub 2020 Nov 4.

  • Chung SW, Yoon JP, Oh KS, Kim HS, Kim YG, Lee HJ, Jeong WJ, Kim DH, Lee JS, Yoon JW. Rotator cuff tear and sarcopenia: are these related? J Shoulder Elbow Surg. 2016 Sep;25(9):e249-55. doi: 10.1016/j.jse.2016.02.008. Epub 2016 Apr 12.

  • Han DS, Wu WT, Hsu PC, Chang HC, Huang KC, Chang KV. Sarcopenia Is Associated With Increased Risks of Rotator Cuff Tendon Diseases Among Community-Dwelling Elders: A Cross-Sectional Quantitative Ultrasound Study. Front Med (Lausanne). 2021 May 5;8:630009. doi: 10.3389/fmed.2021.630009. eCollection 2021.

  • Kara M, Kara O, Durmus ME, Analay P, Sener FE, Citir BN, Korkmaz GO, Unlu Z, Tiftik T, Gurcay E, Mulkoglu C, Yalcinkaya B, Bagcier F, Aksakal MF, Erdogan K, Sertcelik A, Cakir B, Kaymak B, Ozcakar L. The Relationship Among Probable SARCopenia, Osteoporosis and SuprasPinatus Tendon Tears in Postmenopausal Women: The SARCOSP Study. Calcif Tissue Int. 2024 Apr;114(4):340-347. doi: 10.1007/s00223-024-01183-7. Epub 2024 Feb 12.

  • Kim JH, Jang I, Jeong S, Shin J, Yoon S, Lee H, Lee S. Examining the Relationship Between Sarcopenia and Rotator Cuff Tears: A Retrospective Comparative Study. J Clin Med. 2025 Jan 2;14(1):220. doi: 10.3390/jcm14010220.

MeSH Terms

Conditions

Rotator Cuff InjuriesSarcopeniaShoulder Pain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPain

Central Study Contacts

sibel Suzen Ozbayrak, M.D.

CONTACT

Elem Yorulmaz, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

January 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations