- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589485
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
June 19, 2017 updated by: Zimmer Biomet
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.
Study Overview
Status
Withdrawn
Intervention / Treatment
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Warsaw, Indiana, United States, 46581
- Biomet Orthopedics, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population will include patients who require total knee replacement.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
|
This arm will utilize Simplex® Bone Cement in total knee replacement.
|
2
|
This arm utilizes Cobalt™ Bone Cement in total knee replacement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic analysis and Knee Society Score
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
January 3, 2008
First Posted (Estimate)
January 9, 2008
Study Record Updates
Last Update Posted (Actual)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 19, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102-U-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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