Functional and Radiographic Outcomes After Shoulder Surgery

NCT01405781 | Completed

• 1 other identifier: 46622
• Study Type: observational
• Target: 1,034
• Locations: 1 country
• Sites: 2

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.

Conditions

Shoulder Pain; Osteoarthritis of Glenohumeral Joint; Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

• To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems.

  From 6 months

Secondary Outcomes (1)

• To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair

  from 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

University Of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

Location

Veterans Administration Hospital Salt Lake City

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chondrocalcinosis; Arthritis; Crystal Arthropathies

Study Officials

• Robert z Tashjian, MD

  University Of Utah Orthopedics Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: May 1, 2011
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

US (2)