Functional Outcomes Following Shoulder Surgery: A Prospective Database

Functional Outcome Following Shoulder Surgery: A Prospective Database

The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of shoulder 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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rotator Cuff Tear; Shoulder Instability

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. The database will be an essential element in the development of an academic shoulder service at the University of Ottawa. Many areas in shoulder surgery are in their infancy in terms of minimally invasive techniques. Several large areas require substantial research in order to refine decision making. The database will allow these questions to be answered using a retrospective model and will provide the background information required to mount larger scale randomized controlled trials. The nature of the database information collection will also allow meaningful research to be completed by the residents in the program in a timely and cost-effective manner. This will be in keeping with the training requirements in Orthopedic surgery and will help promote interest in the area of research for the trainees.The following are examples of questions that the database information could answer through research:

1. Does the length of time taken to access Orthopedic care influence the outcome of surgery in rotator cuff disease? in instability? in arthritis?
2. How does the choice of implant in arthroplasty affect outcome (stemmed implants versus resurfacing arthroplasty)?
3. In subscapularis repair, does technique influence outcome (open subscapularis repair versus arthroscopic subscapularis repair)?

• Study Type: Observational
• Enrollment (Actual): 1874

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

• All of the principal investigator's patients who are scheduled to undergo the following surgical procedures will be approached for participation in this study:

  • arthroscopic instability repairs
  • open instability repairs
  • arthroscopic rotator cuff repairs
  • shoulder arthroplasty
  • arthroscopic superior labral anterior posterior (SLAP) repairs.

Exclusion Criteria:

• Those patients who do not meet all of the above inclusion criteria will be excluded from the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
long term outcome and functional status	The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of shoulder surgery.	2 year follow up

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Peter Lapner, MD, OHRI

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2004
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: November 10, 2005
• First Submitted That Met QC Criteria: November 10, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: long term outcome; shoulder surgery; prospective database
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 2003658-01H