Study Results
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View full resultsBasic Information
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COMPLETED
30 participants
OBSERVATIONAL
2011-02-28
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Knee Prosthesis LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Subjects implanted with DePuy LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Knee Prosthesis Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Subjects implanted with DePuy Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Control
Subjects with normal knees
No interventions assigned to this group
Interventions
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Subjects implanted with DePuy LCS PS RP TKA
Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Subjects implanted with DePuy Sigma PS RP TKA
Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
Eligibility Criteria
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Inclusion Criteria
2. Potential subjects will have a body weight of less than 250 lbs.
3. Candidates must have an AKS score \>70 post-operatively.
4. Patients must have passive flexion of at least 100.
5. Implanted group must have either an LCS PS RP TKA, having an anatomical patella, or Sigma PS RP TKA; or normal knee group must have normal knee.
6. Must be willing to sign both Informed Consent and HIPAA forms.
Exclusion Criteria
2. Subjects not meeting study requirements.
20 Years
85 Years
ALL
Yes
Sponsors
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DePuy Orthopaedics
INDUSTRY
The University of Tennessee, Knoxville
OTHER
Responsible Party
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Richard Komistek
Principal Investigator
Principal Investigators
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Richard D. Komistek, Ph D
Role: PRINCIPAL_INVESTIGATOR
The University of Tennessee
Douglas Dennis, MD
Role: PRINCIPAL_INVESTIGATOR
Colorado Joint Replacement, Porter Adventist Hosp
Locations
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Colorado Joint Replacement
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Perkins Hall
Knoxville, Tennessee, United States
Science and Engineering Research Facility
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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R011373372
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
10035/IIS-000126
Identifier Type: -
Identifier Source: org_study_id
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