Functional and Radiographic Outcomes After Shoulder Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Robert Tashjian, University of Utah
ClinicalTrials.gov Identifier:
NCT01405781
First received: July 27, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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
Shoulder Pain
Osteoarthritis of Glenohumeral Joint
Rotator Cuff Tear Arthropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Functional and Radiographic Outcomes After Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems. [ Time Frame: From 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair [ Time Frame: from 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: May 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  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 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.
  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: NCT01405781

Locations
United States, Utah
Veterans Administration Hospital Salt Lake City
Salt Lake City, Utah, United States, 84108
University Of Utah Orthopedics Center
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
  More Information

No publications provided

Responsible Party: Robert Tashjian, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01405781     History of Changes
Other Study ID Numbers: 46622
Study First Received: July 27, 2011
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Shoulder Pain
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Arthralgia
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014