Status:
COMPLETED
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
Lead Sponsor:
DePuy Orthopaedics
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Detailed Description
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the ...
Eligibility Criteria
Inclusion
- Osteoarthritis
- Rheumatoid arthritis
- Other inflammatory arthritis
- Avascular necrosis (AVN) of bone
- Post-Traumatic Arthritis
- Juvenile Rheumatoid Arthritis
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00289107
Start Date
April 1 2001
End Date
November 1 2007
Last Update
May 3 2023
Active Locations (3)
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1
Greensboro, North Carolina, United States, 27408
2
Austin, Texas, United States, 78746
3
Lakewood, Washington, United States, 98499