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CompletedNCT01515449Updated Jan 24, 2012

Predictors of Poor Outcomes in 1038 Sigma Knees

An observational study in Total Knee Replacement, sponsored by NHS Fife. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2012-01-24.

Sponsored by NHS Fife · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,038
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Total Knee Replacement
03

In context

Lead sponsor

NHS Fife is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing total knee replacement in Fife

Eligibility criteria

Inclusion Criteria:

All patients undergoing total knee replacement in Fife

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,038 participants (actual)
06

What researchers measure

Primary outcomes

  1. Predictors of poor outcomes using 3 measures

    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

    Time frame: 10 years

07

Study locations

1 site
  • NHS Fife
    Kirkcaldy, Fife KY2 5AH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01515449
Lead sponsor
NHS Fife
Collaborators
DePuy International
Responsible party
Ivan Brenkel (Consultant Orthopaedic Surgeon, NHS Fife) — Principal investigator
First posted
Jan 24, 2012
Start date
Oct 1998
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jan 24, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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