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Longitudinal Study of Asymptomatic Rotator Cuff Tears

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085942
First Posted: March 12, 2010
Last Update Posted: December 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital
  Purpose
The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.

Condition
Rotator Cuff Tear

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Study of Asymptomatic Rotator Cuff Tears. A Eight Year Follow-up of Symptomatic Status and Tear Characteristics Like Tear Size, Muscle Atrophy and Fatty Degeneration

Resource links provided by NLM:


Further study details as provided by Stefan Moosmayer, Martina Hansen's Hospital:

Primary Outcome Measures:
  • Symptoms from a rotator cuff tear [ Time Frame: 8 years ]
    The symptomatic status of initially asymptomatic rotator cuff tears is followed up by reexamination after three and eight years

  • Tear characteristics on MRI and sonography [ Time Frame: 8 years ]
    Tear characteristics from initially asymptomatic rotator cuff tears are followed up by reexamination by MRI and sonography after three and eight years


Enrollment: 50
Study Start Date: October 2008
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asymptomatic rotator cuff tear
Subjects identified with an asymptomatic rotator cuff tear

Detailed Description:
Fifty subjects with an asymptomatic rotator cuff tear were identified in an earlier study. Clinical, sonographic and MRI reexamination of these subjects is performed after an interval of three years. Findings of interest include: (1) the symptomatic status of the subjects (still asymptomatic or symptomatic); (2)tear size on sonography and MRI (unchanged or increased); (3)degree of muscle atrophy on MRI (unchanged or deteriorated); (4)degree of fatty muscle degeneration on MRI (unchanged or deteriorated). We want to analyze whether a change in these tear characteristics is associated with a change of the symptomatic status of these subjects.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects identified with an asymptomatic rotator cuff tear
Criteria

Inclusion Criteria:

  • Subjects with an asymptomatic rotator cuff tear at least in one shoulder, tear demonstrated both on MRI and sonography, ASES score exceeding 90 points

Exclusion Criteria:

  • Earlier periods with shoulder pain and dysfunction, earlier treatment for shoulder problems
  Contacts and Locations
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): NCT01085942


Locations
Norway
Martina Hansen's Hospital
Baerum, Norway, 1306
Sponsors and Collaborators
Martina Hansen's Hospital
Investigators
Principal Investigator: Stefan Moosmayer, MD Martina Hansen's Hospital
  More Information

Publications:
Responsible Party: Stefan Moosmayer, MD, PhD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT01085942     History of Changes
Other Study ID Numbers: 288-05082 (REK)
2006049 ( Other Identifier: Helse Soer-Oest )
First Submitted: March 11, 2010
First Posted: March 12, 2010
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Stefan Moosmayer, Martina Hansen's Hospital:
rotator cuff tear
asymptomatic
natural course
tear characteristics
Asymptomatic rotator cuff tears
Natural course of rotator cuff tears

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