NCT01379755

Brief Summary

This is a comparison of the functional results and Varus-Valgus Stability in Single-radius versus Multi-radius Femoral Component for Total Knee Arthroplasty.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 14, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

June 8, 2011

Last Update Submit

July 13, 2011

Conditions

Osteoarthritis

Keywords

stabilitysingle-radiusmulti-radiustotal knee arthroplasty

Eligibility Criteria

Age48 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

56 total knee arthroplasties(TKAs) with a single-radius femoral design (Scorpio NRG) (single-radius(SR) group) and 59 total knee arthroplasties(TKAs) with multiradius femoral design (NexGen CR) (multi-radius(MR) group)

You may qualify if:

  • followed for a minimum of two years.

You may not qualify if:

  • Not followed for a minimum of two years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Joint Disease, Chonnam National University Hwasun Hospital

Hwasun-Gun, Jeollanam-do, 519-809, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jong Keun Seon, Professor

    Center for Joint Disease, Chonnam National University Hwasun Hospital, Jeonnam, Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 23, 2011

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

July 14, 2011

Record last verified: 2011-06

Locations

KR(1)