The Natural History of Asymptomatic Rotator Cuff Tears

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923858
• Other study ID #: IRB# 201103230
• Secondary ID: 5R01AR051026
• Status: Completed
• Start date: July 1, 2005
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The specific aims of our study are: 1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time. 2. To determine which epidemiological factors correlate with symptomatic progression. 3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography. 4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (50)

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Examination by the study coordinator (Range of motion)	Research team member measures shoulder range of motion using a goniometer.	Through study completion, an average of 1 per year
Other	Physical Examination by the study coordinator (Strength)	Research team member measures shoulder strength measured with a dynamometer.	Through study completion, an average of 1 per year
Primary	Standardized Shoulder Ultrasound & Radiographs	The ultrasound involves measurement of rotator cuff tear (if present) and assessment of muscle degeneration. Radiographs will be used to document any bony changes.	Through study completion, an average of 1 per year
Secondary	American Shoulder & Elbow Survey (ASES)	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)	Through study completion, an average of 1 per year
Secondary	Western Ontario Rotator Cuff (WORC) Index	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)	Through study completion, an average of 1 per year
Secondary	Short Form Health Survey (SF-12)	General health assessment composed of two scales, Physical Component Summary and Mental Component Summary (Range: 0-100, higher scores indicate better health)	Through study completion, an average of 1 per year