Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
NCT ID: NCT00289107
Last Updated: 2023-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
149 participants
INTERVENTIONAL
2001-04-01
2007-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System
Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
2
P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Total knee replacement
Fixed Cruciate Substituting Knee System
Interventions
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Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
Total knee replacement
Fixed Cruciate Substituting Knee System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid arthritis
* Other inflammatory arthritis
* Avascular necrosis (AVN) of bone
* Post-Traumatic Arthritis
* Juvenile Rheumatoid Arthritis
Exclusion Criteria
* Charcot neuropathy.
* Psycho-social disorders that would limit rehabilitation.
* Greater than 75 years of age at the time of surgery.
* Prior ipsilateral knee arthroplasty.
* Metabolic disorders of calcified tissues, such as Paget's disease.
* Severe diabetes mellitus.
* Joint replacement due to autoimmune disorders.
* Skeletal immaturity
18 Years
75 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Tammy L O'Dell, EMT, CCRA
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Greensboro, North Carolina, United States
Austin, Texas, United States
Lakewood, Washington, United States
Countries
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Other Identifiers
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SRP-3
Identifier Type: -
Identifier Source: org_study_id
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