Status:
COMPLETED
Does Implant Design Improve Postoperative Flexion?
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Non-inflammatory Arthritis
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee su...
Detailed Description
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®...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00380861
Start Date
March 1 2006
End Date
December 1 2009
Last Update
July 24 2023
Active Locations (4)
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1
Doug Dennis
Denver, Colorado, United States, 80210
2
Heekin Orthopaedics
Jacksonville, Florida, United States, 32204
3
University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
Iowa City, Iowa, United States, 01075
4
Lakewood Orthopaedic Surgeons
Lakewood, Washington, United States, 98499