Functional Outcomes Following Shoulder Surgery: A Prospective Database

Osteoarthritis Clinical Trial

Official title:

Functional Outcome Following Shoulder Surgery: A Prospective Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253864
• Other study ID #: 2003658-01H
• Status: Completed
• Start date: November 2004
• Est. completion date: January 2020

Study information

• Verified date: August 2022
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1874
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Instability

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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