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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00588887
Other study ID # 105-U-014
Secondary ID
Status Terminated
Phase N/A
First received December 21, 2007
Last updated June 19, 2017
Start date June 2005
Est. completion date June 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 range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date June 2008
Est. primary completion date February 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 compartments are involved.

- Patients requiring correction of varus, valgus, or posttraumatic deformity.

- Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

- Patients with infection, sepsis, or osteomyelitis.

Study Design


Intervention

Device:
Duracon®
This group utilizes the Duracon® prostheses for total knee replacement.
Vanguard™
This group will utilize the Vanguard™ prostheses for total knee replacement.

Locations

Country Name City State
United States Biomet Orthopedics, Inc. 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 Range of motion, Knee Society Score, Duration of surgery 1 year
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