Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears

NCT03717571 | Completed

• 1 other identifier: EKNZ 2018-01692
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Outcome Measures

Primary Outcomes (1)

• Glenohumeral translation

  Amount of glenohumeral translation under load

  Baseline

Secondary Outcomes (6)

• Disabilities of arm, shoulder and Hand (DASH)

  Baseline

• Shoulder function

  Baseline

• Shoulder pain

  Baseline

• Critical shoulder angle (CSA)

  Baseline

• Muscle activity

  Baseline

Study Arms (3)

Control group

age and sex matched healthy control persons

Diagnostic Test: Glenohumeral translation assessment

isolated tear

patients with isolated complete supraspinatus muscle tear

Diagnostic Test: Glenohumeral translation assessment

combined tear

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

Diagnostic Test: Glenohumeral translation assessment

Interventions

Glenohumeral translation assessment DIAGNOSTIC_TEST

amount of glenohumeral translation under load

Control group; combined tear; isolated tear

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 45 years ≤ age ≤ 65 years

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Annegret Mündermann, PhD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: October 4, 2018
• Primary Completion: February 22, 2019
• Study Completion: September 30, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

CH (1)