Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

DePuy Orthopaedics

ClinicalTrials.gov Identifier:

NCT00289094

First received: February 7, 2006

Last updated: September 30, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2006

Last Updated Date

September 30, 2011

Start Date ^ICMJE

May 2001

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor.

Original Primary Outcome Measures ^ICMJE

Knee Society scores

Change History

Complete list of historical versions of study NCT00289094 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Complications/Revisions,
Radiographic findings,
SF-12 patient outcomes

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Official Title ^ICMJE

Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis of Bone

Intervention ^ICMJE

Device: Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Retaining Knee System

Other Name: P.F.C.® Sigma™ RP Cruciate Retaining Knee System
Device: Total knee replacement
Fixed Cruciate Retaining Knee System

Other Name: P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System

Study Arm (s)

Active Comparator: 1
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System

Intervention: Device: Total Knee Arthroplasty
Active Comparator: 2
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System

Intervention: Device: Total knee replacement

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00289094

Other Study ID Numbers ^ICMJE

SRP-2

Has Data Monitoring Committee

Responsible Party

DePuy Orthopaedics

Study Sponsor ^ICMJE

DePuy Orthopaedics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Tammy L O'Dell, EMT, CCRA, CCRC

DePuy Orthopaedics

Information Provided By

DePuy Orthopaedics

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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