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Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Replacement
Total knee replacement
Sponsored by
DePuy Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Knee Society Scores
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.

Secondary Outcome Measures

Complications/Revisions
Medical Imaging
SF-12 Patient Outcomes

Full Information

First Posted
February 7, 2006
Last Updated
August 16, 2022
Sponsor
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00289094
Brief Title
Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA
Official Title
Multi-center, Prospective, Clinical Evaluation of the PFC Sigma Rotating Platform Cruciate Retaining Versus PFC Sigma Cruciate Retaining Knee Primary Cases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2001 (Actual)
Primary Completion Date
December 26, 2007 (Actual)
Study Completion Date
December 26, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis of Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System
Arm Title
2
Arm Type
Active Comparator
Arm Description
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement
Other Intervention Name(s)
P.F.C.® Sigma™ RP Cruciate Retaining Knee System
Intervention Description
Rotating Platform (RP) Cruciate Retaining Knee System
Intervention Type
Device
Intervention Name(s)
Total knee replacement
Other Intervention Name(s)
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System
Intervention Description
Fixed Cruciate Retaining Knee System
Primary Outcome Measure Information:
Title
Knee Society Scores
Description
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.
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary Outcome Measure Information:
Title
Complications/Revisions
Time Frame
On-going to end of study.
Title
Medical Imaging
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Title
SF-12 Patient Outcomes
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy L O'Dell, EMT, CCRA, CCRC
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

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Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA

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