Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears

NCT ID: NCT03717571

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2020-09-30

Brief Summary

Degenerative partial and complete rupture of the rotator cuff is a common injury among elder patients. However, the clinical manifestation varies largely with some patients having severe pain and limiting range of motion and others having no complaints. The basic functions of the rotator cuff are to facilitate shoulder motion and stabilization and centering of the glenohumeral joint. The objective of this study is to quantify the difference in superior glenohumeral translation in patients with degenerative rotator cuff tear compared to healthy control subjects and to determine the effect of isolated complete supraspinatus tear and combined complete supraspinatus and either partial infraspinatus or partial subscapularis tear.

Detailed Description

The study will examine a cohort of 10 patients with isolated complete supraspinatus muscle tear and 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear, and a cohort of 10 age-matched healthy control persons. The participants will be recruited from the Clinic of Orthopaedics and Traumatology at the University Hospital Basel. Inclusion criteria: 45 years < age < 65 years; degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear; unilateral rotator cuff tear. Exclusion criteria: traumatic tendon ruptures; prior treatment of the ipsilateral upper extremity; clinical history of the contralateral glenohumeral joint; no complete supraspinatus muscle tear; tears in more than two rotator cuff muscles; neuromuscular disorders affecting upper limb movement; additional pathologies that influence the mobility of the shoulder joint; inability to provide informed consent.

Patients will complete the health questionnaire and reflective markers and electromyographic sensors will be placed on anatomical landmarks and shoulder muscles, respectively, before loaded and unloaded abduction and flexion arm movements will be performed. Centre of rotation of both shoulders will be calculated to determine glenohumeral translation. This parameter will be compared between patient groups and control subjects using linear mixed models with group membership and load as fixed factor and subject as random factor. The critical shoulder angle will be included as covariate into the model to detect a potential modulating role of this factor on glenohumeral translation.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Control group

age and sex matched healthy control persons

Glenohumeral translation assessment

Intervention Type: DIAGNOSTIC_TEST

amount of glenohumeral translation under load

isolated tear

patients with isolated complete supraspinatus muscle tear

Glenohumeral translation assessment

Intervention Type: DIAGNOSTIC_TEST

amount of glenohumeral translation under load

combined tear

patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear

Glenohumeral translation assessment

Intervention Type: DIAGNOSTIC_TEST

amount of glenohumeral translation under load

Interventions

Glenohumeral translation assessment

amount of glenohumeral translation under load

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 45 years ≤ age ≤ 65 years
• Degenerative complete supraspinatus muscle tear or complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear
• Unilateral rotator cuff tear

• 45 years ≤ age ≤ 65 years

Exclusion Criteria

• Traumatic tendon ruptures
• Incomplete supraspinatus muscle tear
• Tears in more than two rotator cuff muscles
• Prior conservative treatment or surgery of the ipsilateral upper extremity
• Clinical history of the contralateral glenohumeral joint
• Range of motion < 90° in abduction and flexion
• Neuromuscular disorders affecting upper limb movement
• Additional pathologies that influence the mobility of the shoulder joints
• Inability to provide informed consent

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annegret Mündermann, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

EKNZ 2018-01692

Identifier Type: -

Identifier Source: org_study_id