- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00999570
High Volume Specialty Knee Replacement Surgeons Achieve Better Clinical and Quality-of-Life Scores
October 21, 2009 updated by: Singapore General Hospital
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary total knee replacements are becoming a commonly performed procedure.
Many general orthopaedists can perform large numbers of such surgeries.
Thus, we aim to find out if there is value of having surgeons with AR fellowship training to perform primary total knee arthroplasty.
This has an implication in the direction of the training of future AR surgeons and in the distribution of operative cases.
Study Type
Observational
Enrollment (Actual)
3458
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
-
-
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Singapore, Singapore, 169608
- Singapore General Hospital
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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
37 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients seen at Singapore General Hospital who require total knee arthroplasty
Description
Inclusion Criteria:
- patients who require total knee arthroplasty seen during the specified period
Exclusion Criteria:
- revision total knee arthroplasty
- unicompartmental or bicompartmental knee arthroplasty
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients operated by AR trained surgeons
patients who had their total knee replacements performed by surgeons who have completed a fellowship training in adult reconstruction surgery
|
|
|
Patients operated by non-AR surgeons
patients who had their total knee replacements performed by orthopaedic surgeons who did not complete an adult reconstruction fellowship training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine whether specialty training or high volume of operative experience is associated with better clinical outcome and quality-of-life scores.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine which other factors are predictors of better outcome score and quality-of-life scores.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sok Chuen Tan, MBBS, MRCS, Singapore General Hospital
- Study Director: Seng Jin Yeo, FRCS, FAMS, Singapore General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2004
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
October 20, 2009
First Submitted That Met QC Criteria
October 21, 2009
First Posted (Estimate)
October 22, 2009
Study Record Updates
Last Update Posted (Estimate)
October 22, 2009
Last Update Submitted That Met QC Criteria
October 21, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2009/626/D
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.