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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DePuy Orthopaedics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2006

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2006

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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