Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears

Rotator Cuff Tear or Rupture, Not Specified as Traumatic Clinical Trial

— ROTCUFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717571
• Other study ID #: EKNZ 2018-01692
• Status: Completed
• Start date: October 4, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2020
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Rupture

Intervention

Diagnostic Test:
• Glenohumeral translation assessment
amount of glenohumeral translation under load

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glenohumeral translation	Amount of glenohumeral translation under load	Baseline
Secondary	Disabilities of arm, shoulder and Hand (DASH)	assessed using the Quick DASH (0 - no problems, 100 - extreme problems)	Baseline
Secondary	Shoulder function	assessed using the Constant Shoulder Score (0 - no problems, >30 extreme problems)	Baseline
Secondary	Shoulder pain	assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)	Baseline
Secondary	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
Secondary	Muscle activity	root mean square of the electromyography (EMG) signal during the arm movements calculated and normalised to the maximal obtained signal intensity	Baseline
Secondary	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