Longitudinal Study of Asymptomatic Rotator Cuff Tears

January 19, 2018 updated by: Stefan Moosmayer, Martina Hansen's Hospital

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

The purpose of this study is to analyze the natural course of asymptomatic rotator cuff tears.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Sandvika, Norway, 1306
        • Martina Hansen's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects identified with an asymptomatic rotator cuff tear

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asymptomatic rotator cuff tear
Subjects identified with an asymptomatic rotator cuff tear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 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
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martina Hansen's Hospital

Investigators

  • Principal Investigator: Stefan Moosmayer, MD, Martina Hansen's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 288-05082 (REK)
  • 2006049 (Other Identifier: Helse Soer-Oest)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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