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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
June 16, 2009
March 8, 2017
July 2005
May 2021   (Final data collection date for primary outcome measure)
Standardized Shoulder Ultrasound & Radiographs [ Time Frame: Annually ]
  • Standardized Shoulder Ultrasound & Radiographs [ Time Frame: Annually ]
  • Physical Examination by the study coordinator [ Time Frame: Annually ]
Complete list of historical versions of study NCT00923858 on ClinicalTrials.gov Archive Site
Patient completes ASES & MOS-26 [ Time Frame: Annually ]
Same as current
Physical Examination by the study coordinator [ Time Frame: Annually ]
Not Provided
 
The Natural History of Asymptomatic Rotator Cuff Tears
Asymptomatic Cuff Tears: A Model for Pain Development - Part B
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.

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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients are recruited from orthopaedic surgeon's clinic.
Rotator Cuff Tear
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
550
July 2021
May 2021   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00923858
IRB# 201103230
5R01AR051026 ( US NIH Grant/Contract Award Number )
No
Not Provided
No
Not Provided
Washington University School of Medicine
Washington University School of Medicine
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Jay D Keener, MD Washington University School of Medicine
Washington University School of Medicine
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP