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I-beam and Cruciate Tibial Components Used in Total Knee Replacement

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00588783
Enrollment
100
Registered
2008-01-09
Start date
2006-08-31
Completion date
2008-10-31
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Arthritis, Knee Arthritis, Osteoarthritis, Rheumatoid Arthritis

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.

Interventions

DEVICEI-beam design

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

DEVICECruciate design

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

Sponsors

New Lexington Clinic
CollaboratorOTHER
Biomet Orthopedics, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients with infection, sepsis, or osteomyelitis.

Design outcomes

Primary

MeasureTime frame
Revision rate10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026