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Functional and Radiographic Outcomes After Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT01405781
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2011
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Tashjian, University of Utah

Brief Summary:
The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.

Condition or disease
Shoulder Pain Osteoarthritis of Glenohumeral Joint Rotator Cuff Tear Arthropathy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Functional and Radiographic Outcomes After Shoulder Surgery
Study Start Date : May 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems. [ Time Frame: From 6 months ]

Secondary Outcome Measures :
  1. To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair [ Time Frame: from 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City.
Criteria

Inclusion Criteria:

  • Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City. All patients presenting complain of shoulder pain will be given the DRAM survey preoperative and then evaluated a minimum of 6 months postoperative.

Exclusion Criteria:

  • All patients who have undergone total shoulder arthroplasty not utilizing a lesser tuberosity osteotomy or who have prior failed rotator cuff repair in the affected shoulder will be excluded.
  • All patients who have undergone an open repair of the supraspinatus or infraspinatus rotator cuff tendons will not be eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405781


Locations
United States, Utah
University Of Utah Orthopedics Center
Salt Lake City, Utah, United States, 84108
Veterans Administration Hospital Salt Lake City
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Robert z Tashjian, MD University Of Utah Orthopedics Center

Responsible Party: Robert Tashjian, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01405781     History of Changes
Other Study ID Numbers: 46622
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Osteoarthritis
Shoulder Pain
Rotator Cuff Injuries
Joint Diseases
Rotator Cuff Tear Arthropathy
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Arthralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Chondrocalcinosis
Crystal Arthropathies