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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00588783
Other study ID # 104-U-013
Secondary ID
Status Terminated
Phase N/A
First received December 21, 2007
Last updated June 19, 2017
Start date August 2006
Est. completion date October 2008

Study information

Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
I-beam design
This group will utilize tibial components with an I-beam design for total knee replacement.
Cruciate design
This group will utilize tibial components with cruciate designs for total knee replacement.

Locations

Country Name City State
United States Biomet Orthopedics, LLC Warsaw Indiana

Sponsors (2)

Lead Sponsor Collaborator
Biomet Orthopedics, LLC New Lexington Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Revision rate 10 years
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