Study Results
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View full resultsBasic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2006-03-01
2009-12-01
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
DOUBLE
Study Groups
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PFC Sigma RP-F
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
PFC Sigma RP
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.
Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement
Interventions
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Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement
Eligibility Criteria
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Inclusion Criteria
* Age = 40-70 years
* Male or female
* Suitable for devices in study
* Needing primary simultaneous bilateral knee replacements
* Willing to consent and authorize release of personal health information
* Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,
Exclusion Criteria
* Multiple joint involvement
* Pregnant/lactating women
* Inflammatory arthritis
* Fixed flexion contracture greater than 20 degrees
* Previous knee replacement of any type
* Needing device(s) not specified in protocol
* The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
* Those who have participated in an investigation in the last 3 months
* Those involved in personal injury litigation, medical-legal or workers compensation claims
* Failure to follow surgical technique details specified in the protocol
40 Years
70 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Tammy O'Dell, EMT, CCRA, CCRC
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Doug Dennis
Denver, Colorado, United States
Heekin Orthopaedics
Jacksonville, Florida, United States
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
Iowa City, Iowa, United States
Lakewood Orthopaedic Surgeons
Lakewood, Washington, United States
Countries
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References
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Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available.
Other Identifiers
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04092
Identifier Type: -
Identifier Source: org_study_id
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