Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00289094
• Date of registration: 07/02/2006
• Primary sponsor: DePuy Orthopaedics
• Public title: Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
• Scientific title: Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
• Date of first enrolment: May 2001
• Target sample size: 99
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00289094
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Contacts

• Name: Tammy L O'Dell, EMT, CCRA, CCRC
• Affiliation: DePuy Orthopaedics

Key inclusion & exclusion criteria

Inclusion Criteria:

- Osteoarthritis

- Rheumatoid Arthritis

- Other inflammatory arthritis

- Avascular necrosis of bone

Exclusion Criteria:

- Prior ipsilateral TKA

- Metabolic disorders

- Joint replacement due to autoimmune disorders



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Avascular Necrosis of Bone

Osteoarthritis

Rheumatoid Arthritis

Intervention(s)

Device: Total Knee Arthroplasty

Device: Total knee replacement

Primary Outcome(s)

Knee Society Scores [Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

Secondary Outcome(s)

Complications/Revisions [Time Frame: On-going to end of study.]

Medical Imaging [Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

SF-12 Patient Outcomes [Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.]

Secondary ID(s)

SRP-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors