Functional Outcomes Following Shoulder Surgery: A Prospective Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00253864
Recruitment Status : Recruiting
First Posted : November 15, 2005
Last Update Posted : March 30, 2018
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief 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.

Condition or disease
Rotator Cuff Tear Osteoarthritis 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
Estimated Enrollment : 2500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Functional Outcome Following Shoulder Surgery: A Prospective Database
Study Start Date : November 2004
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. long term outcome and functional status [ Time Frame: 2 year follow up ]
    The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of shoulder surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00253864

Contact: Peter Lapner, MD 613-737-8377

Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Peter Lapner, MD OHRI

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00253864     History of Changes
Other Study ID Numbers: OHREB 2003658-01H
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Ottawa Hospital Research Institute:
shoulder surgery
prospective database
long term outcome

Additional relevant MeSH terms:
Rotator Cuff Injuries
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Shoulder Injuries
Tendon Injuries