10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01522781

Enrollment

234

Registered

2012-02-01

Start date

1998-10-31

Completion date

2008-10-31

Last updated

2012-02-01

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

Detailed description

A prospective database was set up in October 1998. Patient details are collected pre-operatively, 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 has been done at each visit.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

All patients undergoing total knee replacement in Fife

Design outcomes

Primary

Measure	Time frame	Description
Clinical outcome of the Sigma knee at 10 years	10 years	Patient satisfaction scores SF 12 and Oxford American Knee society score

Secondary

Measure	Time frame	Description
Radiographic outcomes at 10 years	10 years	looking for failure by identitying lucent lines and osteolysis

Countries

United Kingdom

Outcome results