The Natural History of Asymptomatic Rotator Cuff Tears

NCT00923858 | Completed

• 2 other identifiers: IRB# 2011032305R01AR051026
• Study Type: observational
• Target: 495
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff; Ultrasound; Pain; Tear Progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• American Shoulder & Elbow Survey (ASES)

  Through study completion, an average of 1 per year

• Western Ontario Rotator Cuff (WORC) Index

  Through study completion, an average of 1 per year

• Short Form Health Survey (SF-12)

  Through study completion, an average of 1 per year

Other Outcomes (2)

• Physical Examination by the study coordinator (Range of motion)

  Through study completion, an average of 1 per year

• Physical Examination by the study coordinator (Strength)

  Through study completion, an average of 1 per year

Study Arms (2)

Control - participants from cycles 1 & 2

no intervention. Control group is composed of participants from Cohort I (recruited during our first grant cycle) and from Cohort II (recruited during our second grant cycle). Continued observation is planned for those controls, partial tears and full tears who enrolled in study at age 65 years or younger and have less than 11 years of follow up.

Cuff Tear Cohort III

These participants are being recruited from our clinical population and have been scheduled to undergo a standard of care rotator cuff repair and post op therapy. One shoulder has been indicated for rotator cuff repair and the contralateral shoulder is asymptomatic. Both shoulders will be monitored.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from orthopaedic surgeon's clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Workman's Compensation claim involving the shoulders.
• Use of crutch, cane or weight-bearing device on study shoulder.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay D Keener, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: July 1, 2005
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)