Does Implant Design Improve Postoperative Flexion?
Launched by DEPUY ORTHOPAEDICS · Sep 26, 2006
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Non-Inflammatory Arthritis
- • 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:
- • Existing conditions that would compromise participation
- • 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
About Depuy Orthopaedics
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, is a leading global provider of orthopedic medical devices, specializing in the development, manufacturing, and marketing of innovative solutions for joint reconstruction, trauma, and spinal care. With a commitment to advancing patient outcomes through cutting-edge technology and evidence-based practices, DePuy Orthopaedics actively engages in clinical trials to evaluate the safety and efficacy of its products. The company collaborates with healthcare professionals and institutions to ensure that its offerings meet the highest standards of quality and effectiveness, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Denver, Colorado, United States
Jacksonville, Florida, United States
Iowa City, Iowa, United States
Lakewood, Washington, United States
Patients applied
Trial Officials
Tammy O'Dell, EMT, CCRA, CCRC
Study Director
DePuy Orthopaedics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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