Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
This study has been terminated.
Sponsor:
Biomet, Inc.
Collaborator:
New Lexington Clinic
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00589485
First received: December 21, 2007
Last updated: May 1, 2012
Last verified: May 2012
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![](https://webarchive.library.unt.edu/web/20121019031548im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.
Condition | Intervention |
---|---|
Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Knee Arthritis |
Device: Simplex® Bone Cement Device: Cobalt™ Bone Cement |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- Radiographic analysis and Knee Society Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Enrollment: | 100 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2017 |
Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
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.
|
![](https://webarchive.library.unt.edu/web/20121019031548im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study Population
The study population will include patients who require total knee replacement.
Criteria
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
![](https://webarchive.library.unt.edu/web/20121019031548im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20121019031548im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00589485 History of Changes |
Other Study ID Numbers: | 102-U-012 |
Study First Received: | December 21, 2007 |
Last Updated: | May 1, 2012 |
Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Cobalt Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012