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Trial record 66 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

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ClinicalTrials.gov Identifier: NCT03717571
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Rotator Cuff Tear or Rupture, Not Specified as Traumatic 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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




Primary Outcome Measures :
  1. Glenohumeral translation [ Time Frame: Baseline ]
    Amount of glenohumeral translation under load


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717571


Contacts
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Contact: Annegret Mündermann, PhD +41 61 328 5445 annegret.muendermann@unibas.ch
Contact: Corina Nüesch, PhD +41 61 265 9444 corina.nueesch@usb.ch

Locations
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Switzerland
University Hospital Basel Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact: Annegret Mündermann, PhD    +41 61 265 94 44    annegret.muendermann@unibas.ch   
Contact: Corina Nüesch, PhD    +41 61 265 94 44    corina.nueesch@usb.ch   
Sub-Investigator: Felix Malzner, BSc         
Sub-Investigator: Andreas M Müller, MD         
Sub-Investigator: Stefan Loske, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Annegret Mündermann, PhD University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03717571     History of Changes
Other Study ID Numbers: EKNZ 2018-01692
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rupture
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries