Functional Outcomes Following Shoulder Surgery: A Prospective Database

This study is currently recruiting participants.
Verified January 2014 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00253864
First received: November 10, 2005
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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
Rotator Cuff Tear
Osteoarthritis
Shoulder Instability

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Functional Outcome Following Shoulder Surgery: A Prospective Database

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • long term outcome and functional status [ Time Frame: 2 year follow up ] [ Designated as safety issue: No ]
    The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of shoulder surgery.


Estimated Enrollment: 2500
Study Start Date: November 2004
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
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)?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253864

Contacts
Contact: Peter Lapner, MD 613-737-8377

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

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00253864     History of Changes
Other Study ID Numbers: OHREB 2003658-01H
Study First Received: November 10, 2005
Last Updated: January 21, 2014
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014