Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA - Full Text View

Sponsored by:	DePuy Orthopaedics
Information provided by:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00289094

Purpose

The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Condition	Intervention	Phase
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis of Bone	Device: Total Knee Arthroplasty Device: Total knee replacement	Phase IV

MedlinePlus related topics: Knee Replacement Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:

Knee Society scores [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complications/Revisions [ Time Frame: On-going to end of study. ] [ Designated as safety issue: Yes ]
Medical imaging [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: Yes ]
SF-12 patient outcomes [ Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	May 2001
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System	Device: Total Knee Arthroplasty Rotating Platform (RP) Cruciate Retaining Knee System
2: Active Comparator P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System	Device: Total knee replacement Fixed Cruciate Retaining Knee System

Detailed Description:

This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289094

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Study Director:

Tammy L O'Dell, EMT, CCRA, CCRC

DePuy Orthopaedics

More Information

No publications provided

Responsible Party:	DePuy Orthopaedics, Inc. ( Tammy O'Dell, EMT, CCRA )
Study ID Numbers:	SRP-2
Study First Received:	February 7, 2006
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00289094 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009