Functional Outcomes Following Shoulder Surgery: A Prospective Database

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00253864
Study type	Observational
Source	Ottawa Hospital Research Institute
Contact
Status	Completed
Phase
Start date	November 2004
Completion date	January 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.