Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
April Armstrong, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00779415
First received: October 22, 2008
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.


Condition
Rotator Cuff Tear

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Creation of a database of patients with partial rotator cuff tears documented by MRI. [ Time Frame: Retrospective review from 1/1/02 to 12/31/06, four years. ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Partial Rotator Cuff Tear
Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department

Detailed Description:

We plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the Hershey Medical Center. Participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. Data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department.

Criteria

Inclusion Criteria:

  • Patients examined at the Hershey Medical Center from 1/1/02-12/31/06 with a documented MRI report of a partial thickness tear of the rotator cuff that was treated non-operatively.

Exclusion Criteria:

  • Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00779415

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: April D Armstrong, MD Milton S. Hershey Medical Center
  More Information

Publications:
Responsible Party: April Armstrong, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00779415     History of Changes
Other Study ID Numbers: IRB26682EP
Study First Received: October 22, 2008
Last Updated: February 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Partial Thickness
Rotator Cuff

ClinicalTrials.gov processed this record on May 21, 2015