Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00589485
• Collaborator: New Lexington Clinic (Other)
• Enrollment: 0
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Knee Arthritis	Device: Simplex® Bone Cement; Device: 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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
1	Device: Simplex® Bone Cement; This arm will utilize Simplex® Bone Cement in total knee replacement.
2	Device: Cobalt™ Bone Cement; This arm utilizes Cobalt™ Bone Cement in total knee replacement.

Outcome Measures

Primary Outcome Measures

1. Radiographic analysis and Knee Society Score [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biomet Orthopedics, LLC	Warsaw	Indiana	United States	46581

Sponsors and Collaborators

• Zimmer Biomet
• New Lexington Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00589485
• Other Study ID Numbers: 102-U-012
• First Posted: Jan 9, 2008
• Last Update Posted: Jun 21, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Arthritis; Cobalt

Study Results

No Results Posted as of Jun 21, 2017