Outcome Following Orthopaedic Surgery

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: NCT00261066
Recruitment Status : Recruiting
First Posted : December 2, 2005
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
By investigating the long-term functional status of patients who have undergone various types of orthopaedic surgery we will have a basis for devising guidelines for future patients and surgeons.

Condition or disease
Osteoarthritis of Knee

Detailed Description:
The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of orthopaedic surgery. These data will yield a valuable database that can be used to address future research questions. For example, there are three common surgical treatments for medial osteoarthritis of the knee: tibial osteotomy, Oxford partial knee replacement, or total knee replacement. No clear guidelines exist regarding which treatment options are optimal for which patients. By gathering functional data from patients who have undergone these treatments, we will have a basis for devising such guidelines.

Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Database for Orthopaedic Surgery
Study Start Date : September 2001
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Koos [ Time Frame: 10y ]

Secondary Outcome Measures :
  1. ShortForm-12 [ Time Frame: 10Years ]

  2. Tegner-ulca [ Time Frame: 10Years ]

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
Patients who are scheduled to undergo orthopaedic surgery at The Ottawa Hospital.

Inclusion Criteria:

  • All patients who are scheduled to undergo orthopaedic surgery are eligible to be included in the database.

Exclusion Criteria:

  • Those patients who do not meet 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): NCT00261066

Contact: Geoffrey Dervin, MD 613-737-8920

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

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00261066     History of Changes
Other Study ID Numbers: OHREB 2003209-01H
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
Functional outcome
Orthopaedic surgery

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases