Status:
TERMINATED
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Osteoarthritis
Arthritis, Rheumatoid
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring an...
Detailed Description
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Si...
Eligibility Criteria
Inclusion
- Osteoarthritis
- Rheumatoid arthritis
- Avascular necrosis (AVN) of bone
- Other inflammatory arthritis
- Post-traumatic arthritis
- Juvenile rheumatoid arthritis
Exclusion
- Prior ipsilateral TKA
- Metabolic disorders
- Joint replacement due to autoimmune disorders
- History of recent/active joint sepsis
- Charcot neuropathy
- Psycho-social disorders that would limit rehabilitation
- Greater than 75 years of age at the time of surgery
- Severe diabetes mellitus
- Skeletal immaturity
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00289081
Start Date
February 1 2001
End Date
June 1 2006
Last Update
May 13 2014
Active Locations (4)
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1
La Jolla, California, United States, 92037
2
West Coast Orthopaedic Specialists
Crystal River, Florida, United States, 34429
3
Melbourne, Florida, United States, 32901
4
Cleveland Heights, Ohio, United States, 44118