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

Sponsor

Biomet Orthopedics, LLC (Industry)

Overall Status

Terminated

CT.gov ID

NCT00588783

Collaborator

New Lexington Clinic (Other)

100

Enrollment

Location

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis Osteoarthritis Rheumatoid Arthritis Knee Arthritis	Device: I-beam design Device: Cruciate design

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1	Device: I-beam design This group will utilize tibial components with an I-beam design for total knee replacement.
2	Device: Cruciate design This group will utilize tibial components with cruciate designs for total knee replacement.

Arm

Intervention/Treatment

Device: I-beam design

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

Device: Cruciate design

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

Outcome Measures

Primary Outcome Measures

Revision rate [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biomet Orthopedics, LLC	Warsaw	Indiana	United States	46581

Sponsors and Collaborators

Biomet Orthopedics, LLC
New Lexington Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biomet Orthopedics, LLC

ClinicalTrials.gov Identifier:

NCT00588783

Other Study ID Numbers:

104-U-013

First Posted:

Jan 9, 2008

Last Update Posted:

Jun 21, 2017

Last Verified:

Jun 1, 2017

Additional relevant MeSH terms:

Arthritis

Osteoarthritis

Study Results

No Results Posted as of Jun 21, 2017