Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears (ROTCUFF)

ROTCUFF - Measuring Load-induced Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears and Asymptomatic Subjects: 3-dimensional Motion Analysis Versus Single Plane Fluoroscopy

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Intervention / Treatment: Diagnostic test: Glenohumeral translation assessment

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4031
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• 10 patients with isolated complete supraspinatus muscle tear
• 10 patients with complete supraspinatus muscle tear and either partial infraspinatus muscle tear or partial subscapularis muscle tear
• 10 healthy control subjects

Description

Inclusion criteria patients

• 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 patients

• 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

Inclusion criteria healthy control subjects

• 45 years ≤ age ≤ 65 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; age and sex matched healthy control persons	Diagnostic test: Glenohumeral translation assessment; amount of glenohumeral translation under load
isolated tear; patients with isolated complete supraspinatus muscle tear	Diagnostic test: Glenohumeral translation assessment; 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	Diagnostic test: Glenohumeral translation assessment; amount of glenohumeral translation under load

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glenohumeral translation	Amount of glenohumeral translation under load	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of arm, shoulder and Hand (DASH)	assessed using the Quick DASH (0 - no problems, 100 - extreme problems)	Baseline
Shoulder function	assessed using the Constant Shoulder Score (0 - no problems, >30 extreme problems)	Baseline
Shoulder pain	assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)	Baseline
Critical shoulder angle (CSA)	measured on frontal plane radiographs in neutral arm position available from the clinical consultation. The CSA is the angle between the line connecting the superior with the inferior border of the glenoid fossa and the line connecting the inferior border of the glenoid fossa with the most inferolateral point of the acromion	Baseline
Muscle activity	root mean square of the electromyography (EMG) signal during the arm movements calculated and normalised to the maximal obtained signal intensity	Baseline
Glenohumeral translation from fluoroscopy	the perpendicular distance of the centre of the glenohumeral joint and the x-axis of the scapula coordinate system will be measured. Glenohumeral translation will be defined as the difference in this distance between the abducted arm positions and the resting arm position	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Annegret Mündermann, PhD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): February 22, 2019
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Rupture
• Other Study ID Numbers: EKNZ 2018-01692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No