Skip to main content
Clinical Trials/NCT00253864
NCT00253864
Completed
Not Applicable

Functional Outcome Following Shoulder Surgery: A Prospective Database

Ottawa Hospital Research Institute1 site in 1 country90 target enrollmentNovember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear
Sponsor
Ottawa Hospital Research Institute
Enrollment
90
Locations
1
Primary Endpoint
Western Ontario Rotator Cuff Index
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.

Detailed Description

The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results. For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
January 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • arthroscopic rotator cuff repairs that occurred between 2007-2009
  • enrolled in previous study comparing single vs double-row fixation

Exclusion Criteria

  • withdrew from original study
  • unable or unwilling to provide written informed consent
  • excluded from original study

Outcomes

Primary Outcomes

Western Ontario Rotator Cuff Index

Time Frame: 10 year post operative

The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

Secondary Outcomes

  • Constant Score(10 year post operative)
  • American Shoulder and Elbow Surgeons Score(10 year post operative)
  • Strength(10 year post operative)

Study Sites (1)

Loading locations...

Similar Trials