Longitudinal Study of Asymptomatic Rotator Cuff Tears

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stefan Moosmayer, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01085942
First received: March 11, 2010
Last updated: October 11, 2013
Last verified: October 2013
  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

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

Primary Outcome Measures:
  • Symptoms from a rotator cuff tear [ Time Frame: 8 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2016 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 11, 2010
Last Updated: October 11, 2013
Health Authority: The National Committees for Research Ethics in Norway:
Norwegian Social Science Data Services, Norway:

Keywords provided by 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:
Lacerations
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014