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

Terminated

• Conditions: Rheumatoid Arthritis; Degenerative Arthritis; Knee Arthritis; Osteoarthritis
• Interventions: Device: Cruciate design; Device: I-beam design

• Registration Number: NCT00588783
• Lead Sponsor: Biomet Orthopedics, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Cruciate design	-
1	I-beam design	-

Primary Outcome Measures

Name	Time	Method
Revision rate	10 years

Trial Locations

Locations (1)

Biomet Orthopedics, LLC; 🇺🇸 Warsaw, Indiana, United States