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Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00589485
Enrollment
0
Registered
2008-01-09
Start date
2006-11-30
Completion date
2006-11-30
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

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.

Interventions

DEVICESimplex® Bone Cement

This arm will utilize Simplex® Bone Cement in total knee replacement.

DEVICECobalt™ Bone Cement

This arm utilizes Cobalt™ Bone Cement in total knee replacement.

Sponsors

New Lexington Clinic
CollaboratorOTHER
Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Radiographic analysis and Knee Society Score10 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026