Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Knee Arthritis
Intervention: Simplex® Bone Cement (Device); Cobalt™ Bone Cement (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Biomet Orthopedics, Inc.
Summary
The purpose of this study is to collect radiographic and clinical outcomes of total knee
replacement using Simplex® or Cobalt™ Bone Cement.
Clinical Details
Study design: Cohort, Prospective
Primary outcome: Radiographic analysis and Knee Society Score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Biomet Orthopedics, Inc., Warsaw, Indiana 46581, United States
Additional Information
Starting date: November 2006
Ending date: November 2017
Last updated: January 3, 2008
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