Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Withdrawn

• Conditions: Traumatic Arthritis; Knee Arthritis; Osteoarthritis; Rheumatoid Arthritis
• Interventions: Device: Cobalt™ Bone Cement; Device: Simplex® Bone Cement

• Registration Number: NCT00589485
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-03
• Study First Posted: 2008-01-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Cobalt™ Bone Cement	-
1	Simplex® Bone Cement	-

Primary Outcome Measures

Name	Time	Method
Radiographic analysis and Knee Society Score	10 years

Trial Locations

Locations (1)

Biomet Orthopedics, LLC; 🇺🇸 Warsaw, Indiana, United States