NCT01522781

Brief Summary

The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1998

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1998

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

10 years

First QC Date

January 24, 2012

Last Update Submit

January 27, 2012

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome of the Sigma knee at 10 years

    Patient satisfaction scores SF 12 and Oxford American Knee society score

    10 years

Secondary Outcomes (1)

  • Radiographic outcomes at 10 years

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing total knee replacement in Fife

You may qualify if:

  • All patients undergoing total knee replacement in Fife

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fife Health Board

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic Surgeon. Lead investigator

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 1, 2012

Study Start

October 1, 1998

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

GB(1)