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Completed

NCT Number: NCT01085942

Longitudinal Study of Asymptomatic Rotator Cuff Tears

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

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Martina Hansen's Hospital

Sandvika, 1306, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 12, 2010
Registry last updated
Jan 23, 2018

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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