NCT00588783

Brief Summary

The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
9 months 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
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2.2 years

First QC Date

December 21, 2007

Last Update Submit

June 19, 2017

Conditions

Degenerative ArthritisOsteoarthritisRheumatoid ArthritisKnee Arthritis

Outcome Measures

Primary Outcomes (1)

  • Revision rate

    10 years

Study Arms (2)

1

Device: I-beam design

2

Device: Cruciate design

Interventions

I-beam designDEVICE

This group will utilize tibial components with an I-beam design for total knee replacement.

1
Cruciate designDEVICE

This group will utilize tibial components with cruciate designs for total knee replacement.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include patients requiring total knee replacement.

You may qualify if:

  • Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
  • Patients requiring correction of varus, valgus, or posttraumatic deformity
  • Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

You may not qualify if:

  • Patients with infection, sepsis, or osteomyelitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomet Orthopedics, LLC

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 9, 2008

Study Start

August 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

US(1)