Does Implant Design Improve Postoperative Flexion?

July 21, 2023 updated by: DePuy Orthopaedics

Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects

This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.

Study Type

Interventional

Enrollment (Actual)

93

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
    • Colorado
      • Denver, Colorado, United States, 80210
        • Doug Dennis
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Heekin Orthopaedics
    • Iowa
      • Iowa City, Iowa, United States, 01075
        • University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery
    • Washington
      • Lakewood, Washington, United States, 98499
        • Lakewood Orthopaedic Surgeons

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Non-Inflammatory Arthritis
  • Age = 40-70 years
  • Male or female
  • Suitable for devices in study
  • Needing primary simultaneous bilateral knee replacements
  • Willing to consent and authorize release of personal health information
  • Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,

Exclusion Criteria:

  • Existing conditions that would compromise participation
  • Multiple joint involvement
  • Pregnant/lactating women
  • Inflammatory arthritis
  • Fixed flexion contracture greater than 20 degrees
  • Previous knee replacement of any type
  • Needing device(s) not specified in protocol
  • The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
  • Those who have participated in an investigation in the last 3 months
  • Those involved in personal injury litigation, medical-legal or workers compensation claims
  • Failure to follow surgical technique details specified in the protocol

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PFC Sigma RP-F
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
Device: Total knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
Active Comparator: PFC Sigma RP
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.
Device: Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Passive Flexion at 6 Months
Time Frame: 6 months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee
Time Frame: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
Patient Specific Anthropometrics
Time Frame: Collected at pre-op
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
Collected at pre-op
American Knee Society (AKS) Score
Time Frame: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.
Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
KOOS Pain Sub-score
Time Frame: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
Time Frame: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
Patellar Crepitus Defined as No Crepitus, FINE or COARSE
Time Frame: Collected at Pre-operative, 6 weeks and 6 and 12 months
Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.
Collected at Pre-operative, 6 weeks and 6 and 12 months
Subject Satisfaction
Time Frame: Collected pre-and post-op, reported at 12-months
Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients
Collected pre-and post-op, reported at 12-months
Single Leg Active Flexion (SLAF)
Time Frame: Pre-op, 6- and 12-months
Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.
Pre-op, 6- and 12-months

Collaborators and Investigators

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

Sponsor

DePuy Orthopaedics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimated)

September 27, 2006

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04092

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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