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NCT Number: NCT00923858

The Natural History of Asymptomatic Rotator Cuff Tears

The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish the probability that an asymptomatic rotator cuff tear, identified in the context of contralateral symptoms, will become symptomatic over time. To determine with ultrasound the probability that a rotator cuff tear will enlarge over time. To determine if symptom progression correlates with enlargement of the rotator cuff tear and/or degenerative changes on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1 year time points over a 5 year period. The study subjects will have repeat physical exam, ultrasound and radiographic examinations. A control group of normal patients will also be followed for comparison.

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Key information

Conditions

Rotator Cuff Tear Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

The specific aims of our study are:

  • To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
  • To determine which epidemiological factors correlate with symptomatic progression.
  • To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
  • To determine the value of routine sonographic scanning of the asymptomatic shoulder.

Who can participate

Healthy volunteers accepted: No

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

Group 1 (Cohorts I & II) Inclusion Criteria:

  • Participants who enrolled at age 65 years or younger will remain in the study.
  • Less than 11 annual visits of non-operative surveillance of study shoulder.
  • Less than 3 annual visits following a rotator cuff repair of study shoulder.

Group 1 (Cohorts I & II) Exclusion Criteria:

  • Workman's Compensation claim involving the shoulders.
  • Use of crutch, cane or weight-bearing device on study shoulder.
  • Moderate or severe glenohumeral arthritis.
  • Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
  • Inability to return for routine study visits.
  • Traumatic injury to rotator cuff.
  • Rotator Cuff Tear greater than 30mm in width.
  • Advanced fatty muscle degeneration.

Patients who are currently enrolled but require a shoulder replacement will not remain in the study. Cohorts I & II will now be considered the control group for comparison to those enrolled in this next recruitment period.

Group 2 (Cohort III) Inclusion Criteria:

  • Age 65 years or younger.
  • Surgical candidate for primary, double-row repair of a rotator.
  • Able to comply with post operative therapy protocol.
  • Bilateral partial or full thickness rotator cuff tears: one symptomatic requiring surgery and the contralateral shoulder asymptomatic.

Group 2 (Cohort III) Exclusion Criteria:

  • Workman's Compensation claim involving the shoulders.
  • Use of crutch, cane or weight-bearing device on study shoulder.
  • Moderate or severe glenohumeral arthritis.
  • Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
  • Inability to return for routine study visits.
  • Traumatic injury to rotator cuff.
  • Rotator Cuff Tear greater than 30mm in width.
  • Advanced fatty muscle degeneration.

Treatment and study plan

Primary outcomes

  1. Standardized Shoulder Ultrasound & Radiographs

    Time frame: Through study completion, an average of 1 per year

    The ultrasound involves measurement of rotator cuff tear (if present) and assessment of muscle degeneration. Radiographs will be used to document any bony changes.

Secondary outcomes

  1. American Shoulder & Elbow Survey (ASES)

    Time frame: Through study completion, an average of 1 per year

    Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder & elbow in different planes of motion. Pain and weakness with various activities are also addressed. (Range 0-100, higher scores indicate better outcomes)

  2. Western Ontario Rotator Cuff (WORC) Index

    Time frame: Through study completion, an average of 1 per year

    Disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to rotator cuff tendinopathy. (Range: 0-2100, normalized to 0-100, higher scores indicate worst possible symptoms)

  3. Short Form Health Survey (SF-12)

    Time frame: Through study completion, an average of 1 per year

    General health assessment composed of two scales, Physical Component Summary and Mental Component Summary (Range: 0-100, higher scores indicate better health)

Other outcomes

  1. Physical Examination by the study coordinator (Range of motion)

    Time frame: Through study completion, an average of 1 per year

    Research team member measures shoulder range of motion using a goniometer.

  2. Physical Examination by the study coordinator (Strength)

    Time frame: Through study completion, an average of 1 per year

    Research team member measures shoulder strength measured with a dynamometer.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Asymptomatic Cuff Tears: A Model for Pain Development - Part B

Important dates

Study start
2005
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2009
Registry last updated
Aug 31, 2022

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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