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

Zimmer Biomet

Status: Terminated

Conditions: Knee Arthritis; Osteoarthritis; Degenerative Arthritis; Rheumatoid Arthritis

Treatments: Device: I-beam design; Device: Cruciate design

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00588783

104-U-013

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

1

Treatment:

Device: I-beam design

2

Treatment:

Device: Cruciate design