Post-Market Study of the 3DKnee™ System

March 15, 2021 updated by: Encore Medical, L.P.

Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Study Type

Observational

Enrollment (Actual)

229

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
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Longo Orthopedics
    • California
      • Fresno, California, United States, 93710
        • Center for Excellence
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • OrthoMaryland
      • Silver Spring, Maryland, United States, 20910
        • Metro Orthopedics and Sports Therapy
    • Missouri
      • Camdenton, Missouri, United States, 65020
        • Leslie Orthopedics and Sports Medicine
      • Saint Peters, Missouri, United States, 63376
        • St. Peter's Bone & Joint Surgery
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Center for Joint Replacement
    • Utah
      • Saint George, Utah, United States, 84790
        • Rimrock Orthopedics

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are over 18 years of age and are candidates for a primary total knee replacement.

Description

Inclusion Criteria:

  • This must be a primary knee replacement on this knee.
  • Patient is over 18 years of age or older

  • Have knee joint disease related to one or more of the following

    • degenerative joint disease, including osteoarthritis or traumatic arthritis
    • Avascular necrosis of the femoral condyles
    • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
    • Moderate valgus, varus, or flexion deformities
    • Rheumatoid arthritis
  • Patient is likely to be available for evaluation for the duration of the study
  • Able and willing to sign the informed consent and follow study procedures
  • Patient is not pregnant

Exclusion Criteria:

  • Is younger than 18 years of age
  • If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
  • Infection, or history of infection, acute or chronic, local or systemic
  • Alcoholism or other addictions
  • Muscular, neurological or vascular deficiencies which compromise the affected extremity
  • Obesity
  • Insufficient bone quality
  • Loss of ligamentous structures
  • High levels of physical activity
  • Materials sensitivity
  • Prisoner
  • Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
  • Patient is pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3DKnee
Post Market Study
Device: 3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
efficacy of total knee system
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
change in Knee Society Score
Time Frame: 5 year
5 year
change in pain from pre-op to post-op
Time Frame: 5 year
5 year
patient satisfaction
Time Frame: 5 year
5 year
change in WOMAC Osteoarthritis Index from pre-surgery
Time Frame: 5 year
5 year
change in Oxford Knee Score from pre-surgery
Time Frame: 5 year
5 year

Collaborators and Investigators

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

Sponsor

Encore Medical, L.P.

Investigators

  • Principal Investigator: John W. McAllister, M.D., St. Peter's Bone and Joint Surgery
  • Principal Investigator: Barry J Waldman, M.D., OrthoMaryland

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.

Helpful Links

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)

February 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS - 700

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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