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The Natural History of Asymptomatic Rotator Cuff Tears

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00923858
First received: June 16, 2009
Last updated: April 11, 2013
Last verified: April 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient completes ASES & MOS-26 [ Time Frame: Annually ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Physical Examination by the study coordinator [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 405
Study Start Date: July 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Partial Thickness Tear
no intervention
Full Thickness Tear
no intervention
No Tear - Control Group
no intervention

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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are recruited from ultrasound and orthopaedic surgeon's clinic.

Criteria

Inclusion Criteria:

  • Had an ultrasound examination to investigate shoulder pain.
  • Discovered to have a partial or full-thickness rotator cuff tear on the"asymptomatic" contralateral side.
  • Verified as being asymptomatic at the initiation of this study.
  • Have no history of trauma and remain injury free during the duration of the study.
  • 18 years or older.

Exclusion Criteria:

  • Any pain (greater than 3/10 on the visual analog pain scale)either previous to or at the time of initiation of the study.
  • Patients who have had a traumatic episode to their asymptomatic shoulder during the intervening time period.
  • Patients with a medical condition such as inflammatory arthropathy, rheumatoid arthritis, psoriatic arthritis, or Lupus which can alter the natural history of rotator cuff disease.
  • Patients who have sought medical attention for problems of the shoulder (includes instability, arthritis, trauma, etc.).
  • Use of the upper extremity for weight bearing.
  • Routinely take NSAIDs or pain medication.
  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
Investigators
Principal Investigator: Ken Yamaguchi, 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
Study First Received: June 16, 2009
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014