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Completed

NCT Number: NCT03717571

Superior Glenohumeral Translation in Patients With Degenerative Rotator Cuff Tears

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.

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Key information

Conditions

Rotator Cuff Tear or Rupture, Not Specified as Traumatic Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glenohumeral translation assessment

Diagnostic Test

amount of glenohumeral translation under load

Primary outcomes

  1. Glenohumeral translation

    Time frame: Baseline

    Amount of glenohumeral translation under load

Secondary outcomes

  1. Disabilities of arm, shoulder and Hand (DASH)

    Time frame: Baseline

    assessed using the Quick DASH (0 - no problems, 100 - extreme problems)

  2. Shoulder function

    Time frame: Baseline

    assessed using the Constant Shoulder Score (0 - no problems, >30 extreme problems)

  3. Shoulder pain

    Time frame: Baseline

    assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)

  4. Critical shoulder angle (CSA)

    Time frame: Baseline

    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

  5. Muscle activity

    Time frame: Baseline

    root mean square of the electromyography (EMG) signal during the arm movements calculated and normalised to the maximal obtained signal intensity

  6. Glenohumeral translation from fluoroscopy

    Time frame: Baseline

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: ROTCUFF

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 24, 2018
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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