- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261066
Outcome Following Orthopaedic Surgery
November 1, 2023 updated by: Ottawa Hospital Research Institute
A Prospective Database for Orthopaedic Surgery
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.
Study Overview
Status
Active, not recruiting
Conditions
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
Enrollment (Actual)
8439
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- Ottawa Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who are scheduled to undergo orthopaedic surgery at The Ottawa Hospital.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Koos
Time Frame: 10y
|
baseline,1y-2y-5y-7y10y
|
10y
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ShortForm-12
Time Frame: 10Years
|
baseline,1y-2y-5y-7y10y
|
10Years
|
|
Tegner-ulca
Time Frame: 10Years
|
baseline,1y-2y-5y-7y10y
|
10Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Geoffrey Dervin, MD, OHRI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2003
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (Estimated)
December 2, 2005
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHREB 2003209-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.