Rheumatoid Arthritis Clinical Trial
Official title:
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
| Verified date | June 2017 |
| Source | Zimmer Biomet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.
| Status | Withdrawn |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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Biomet Orthopedics, LLC | Warsaw | Indiana |
| Lead Sponsor | Collaborator |
|---|---|
| Zimmer Biomet | New Lexington Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Radiographic analysis and Knee Society Score | 10 years |
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