- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01765699
Predicting Poor Outcomes After Primary Knee Arthroplasty
October 7, 2015 updated by: Newcastle-upon-Tyne Hospitals NHS Trust
Aim To identify through data analysis key patients, surgeon and operative dependent variables which will improve the performance of knee replacement for primary osteoarthritis
Research Question
- Can the investigators identify association between outcomes and patients characteristics using existing (already collected) datasets
- What are the characteristics of patients with poor outcome after knee replacement
- What can be done to improve the outcome of patients at risk of poor results
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a retrospective analysis of a prospectively collected single centre database.
Study Type
Observational
Enrollment (Actual)
1300
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have undergone primary knee arthroplasty in our centre.
Description
Inclusion Criteria:
- Primary knee arthroplasty
- Osteoarthritis
Exclusion Criteria:
- No consent for joint registry data collection
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 |
|---|---|
|
Primary knee arthroplasty
Patients with osteoarthritis of the knee undergoing primary knee arthroplasty
|
Patients undergoing primary knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in PROMS
Time Frame: 1,2,3 and 5 Years post op
|
1,2,3 and 5 Years post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Craig Gerrand, Consultant Orthopaedic Surgeon
- Study Director: David Deehan, Consultant Orthopaedic Surgeon
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
February 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
December 31, 2012
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
October 7, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3878
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.