The Natural History of Asymptomatic Rotator Cuff Tears

Study Overview
=================
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Rotator Cuff Tear

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control - participants from cycles 1 & 2<br>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<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotator Cuff, Ultrasound, Pain, Tear Progression