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Predictors of Poor Outcomes in 1038 Sigma Knees

Predictors of Poor Outcomes in 1038 Sigma Knees

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01515449
Enrollment
1038
Registered
2012-01-24
Start date
1998-10-31
Completion date
2008-10-31
Last updated
2012-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

Brief summary

The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

Detailed description

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

Interventions

None listed

Sponsors

DePuy International
CollaboratorINDUSTRY
NHS Fife
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

All patients undergoing total knee replacement in Fife

Design outcomes

Primary

MeasureTime frameDescription
Predictors of poor outcomes using 3 measures10 yearsA 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026