Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

April 4, 2023 updated by: DePuy Orthopaedics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
    • Texas
      • Austin, Texas, United States, 78746
    • Washington
      • Lakewood, Washington, United States, 98499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System
Device: Total Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
Other Names:
  • P.F.C.® Sigma™ RP Cruciate Substituting Knee System
Active Comparator: 2
P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System
Device: Total knee replacement
Fixed Cruciate Substituting Knee System
Other Names:
  • P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
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.
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: On-going to end of study
On-going to end of study
Revisions
Time Frame: On-going to end of study
On-going to end of study
Medical Imaging
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
SF-12 Patient Outcomes
Time Frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Orthopaedics

Investigators

  • Study Director: Tammy L O'Dell, EMT, CCRA, DePuy Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2001

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRP-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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