Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

May 12, 2014 updated by: DePuy Orthopaedics

Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Study Type

Interventional

Enrollment (Actual)

399

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
    • California
      • La Jolla, California, United States, 92037
    • Florida
      • Crystal River, Florida, United States, 34429
        • West Coast Orthopaedic Specialists
      • Melbourne, Florida, United States, 32901
    • Ohio
      • Cleveland Heights, Ohio, United States, 44118

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthritis
  • Rheumatoid arthritis
  • Avascular necrosis (AVN) of bone
  • Other inflammatory arthritis
  • Post-traumatic arthritis
  • Juvenile rheumatoid arthritis

Exclusion Criteria:

  • Prior ipsilateral TKA
  • Metabolic disorders
  • Joint replacement due to autoimmune disorders
  • 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
  • Severe diabetes mellitus
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society scores
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.

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

February 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

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 (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRP-1

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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