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The Natural History of Asymptomatic Rotator Cuff Tears

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00923858
First received: June 16, 2009
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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.

Condition
Rotator Cuff Tear

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Asymptomatic Cuff Tears: A Model for Pain Development - Part B

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Standardized Shoulder Ultrasound & Radiographs [ Time Frame: Annually ]

Secondary Outcome Measures:
  • Patient completes ASES & MOS-26 [ Time Frame: Annually ]

Other Outcome Measures:
  • Physical Examination by the study coordinator [ Time Frame: Annually ]

Estimated Enrollment: 550
Study Start Date: July 2005
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited from orthopaedic surgeon's clinic.
Criteria

Group 1 (Cohorts I & II) Inclusion:

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:

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:

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:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923858

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Jay D Keener, MD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00923858     History of Changes
Other Study ID Numbers: IRB# 201103230
5R01AR051026 ( US NIH Grant/Contract Award Number )
Study First Received: June 16, 2009
Last Updated: March 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:
Rotator Cuff
Ultrasound
Pain
Tear Progression

ClinicalTrials.gov processed this record on June 28, 2017