Predictors of Poor Outcomes in 1038 Sigma Knees
This study has been completed.
Sponsor:
NHS Fife
Collaborator:
De Puy International
Information provided by (Responsible Party):
Ivan Brenkel, NHS Fife
ClinicalTrials.gov Identifier:
NCT01515449
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.
| Condition |
|---|
|
Total Knee Replacement |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Predictors of Poor Outcomes in 1038 Sigma Knees |
Resource links provided by NLM:
Further study details as provided by NHS Fife:
Primary Outcome Measures:
- Predictors of poor outcomes using 3 measures [ Time Frame: 10 years ] [ Designated as safety issue: No ]A prospective database was set up in October 1998. Patient details were collected preoperatively, intra operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American Knee Society Score was done at each visit
| Enrollment: | 1038 |
| Study Start Date: | October 1998 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients undergoing total knee replacement in Fife
Criteria
Inclusion Criteria:
All patients undergoing total knee replacement in Fife
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ivan Brenkel, Consultant Orthopaedic Surgeon, NHS Fife |
| ClinicalTrials.gov Identifier: | NCT01515449 History of Changes |
| Other Study ID Numbers: | IIS2010002 |
| Study First Received: | January 18, 2012 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on May 22, 2013