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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00589485
Other study ID # 102-U-012
Secondary ID
Status Withdrawn
Phase N/A
First received December 21, 2007
Last updated June 19, 2017
Start date November 2006
Est. completion date November 2006

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 collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.


Description:

The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2006
Est. primary completion date November 2006
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:

- Infection, sepsis, and osteomyelitis

Study Design


Intervention

Device:
Simplex® Bone Cement
This arm will utilize Simplex® Bone Cement in total knee replacement.
Cobalt™ Bone Cement
This arm utilizes Cobalt™ Bone Cement in total knee replacement.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Zimmer Biomet New Lexington Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic analysis and Knee Society Score 10 years
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