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Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty
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 focused on measuring Total Knee Replacement, Knee Prosthesis

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 (AVN) of bone Post-Traumatic Arthritis Juvenile Rheumatoid Arthritis 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

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 Cruciate Substituting Knee System

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

Outcomes

Primary Outcome Measures

Knee Society Score
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
April 4, 2023
Sponsor
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00289107
Brief Title
Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2001 (Actual)
Primary Completion Date
November 1, 2007 (Actual)
Study Completion Date
November 1, 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Juvenile Rheumatoid Arthritis, Avascular Necrosis
Keywords
Total Knee Replacement, Knee Prosthesis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System
Arm Title
2
Arm Type
Active Comparator
Arm Description
P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Intervention Type
Device
Intervention Name(s)
Total Knee Arthroplasty
Other Intervention Name(s)
P.F.C.® Sigma™ RP Cruciate Substituting Knee System
Intervention Description
Rotating Platform (RP) Cruciate Substituting Knee System
Intervention Type
Device
Intervention Name(s)
Total knee replacement
Other Intervention Name(s)
P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Intervention Description
Fixed Cruciate Substituting Knee System
Primary Outcome Measure Information:
Title
Knee Society Score
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
Time Frame
On-going to end of study
Title
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 (AVN) of bone Post-Traumatic Arthritis Juvenile Rheumatoid Arthritis 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy L O'Dell, EMT, CCRA
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States

12. IPD Sharing Statement

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Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

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