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

Sponsored by:	DePuy Orthopaedics
Information provided by:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT00289107

Purpose

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

Condition	Intervention	Phase
Total Knee Replacement	Device: Total Knee Arthroplasty Device: Total knee replacement	Phase IV

MedlinePlus related topics: Knee Replacement

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 P.F.C.® Sigma™ Rotating Platform Cruciate Substituting vs P.F.C.® Sigma™ Cruciate Substituting Knee Primary Cases

Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:

Knee Society score [ 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 [ Time Frame: On-going to end of study ] [ Designated as safety issue: Yes ]
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:	150
Study Start Date:	May 2001
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

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 P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting 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 (AVN) of bone

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289107

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Study Director:

Tammy L O'Dell, EMT, CCRA

DePuy Orthopaedics

More Information

No publications provided

Responsible Party:	DePuy Orthopaedics, Inc. ( Tammy O'Dell, EMT, CCRA )
Study ID Numbers:	SRP-3
Study First Received:	February 7, 2006
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00289107 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:

Total Knee Replacement
Knee Prosthesis

ClinicalTrials.gov processed this record on May 07, 2009