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Post Market Study of the 3DKnee™ With E-plus Insert (e-plus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Encore Medical, L.P.
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01551472
First received: March 8, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.


Condition Intervention
Degenerative Joint Disease
Osteoarthritis
Traumatic Arthritis
Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

    The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years.

    Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line.



Secondary Outcome Measures:
  • Change in Knee Society Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).

  • Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    The Western Ontario McMaster Arthritis Index is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It can be self-administered. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability.

  • Change in Oxford Knee Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    The Oxford Knee Score (OKS) is a patient-based outcomes measure consisting of 12 questions that is sensitive, simple and validated. It is based on a maximum score of 48.

  • Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • 6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
3DKnee™ with e-plus Insert
Subjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty.
Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

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. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.

Criteria

Inclusion Criteria:

  • Subject must be a candidate for a total primary knee replacement.
  • Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
  • Subject has a BMI ≤ 40.00 kg/m2
  • Subject is likely to be available for evaluation for the duration of the study
  • Subject is able and willing to sign the informed consent and follow study procedures
  • Subject is not pregnant
  • Subject must be between age 40 and age 75 at the time of consent

Exclusion Criteria:

  • Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
  • Subject has 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 or rheumatoid arthritis
  • Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
  • Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
  • Subject is currently a documented substance abuser (alcohol or other addictions)
  • Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
  • Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
  • Subject has a BMI > 40.00 kg/m2
  • Subject has loss of ligamentous structures
  • Subject has high levels of physical activity and is unwilling to modify levels of physical activity commensurate with recommendations
  • Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
  • Subject is a prisoner
  • Subject is pregnant
  • Subject has known materials sensitivity (to metals)
  • Subject is younger than 40 years (<40) or older than 75 years (>75) at the time of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551472

Contacts
Contact: Beth LG Brakewood, MPH 512-541-6408 beth.brakewood@djoglobal.com

Locations
United States, Alabama
USA Orthopedics Withdrawn
Mobile, Alabama, United States, 36693
United States, Arizona
Valley Bone & Joint Specialists Recruiting
Mesa, Arizona, United States, 85206
Principal Investigator: Salvatore G Lacognata, D.O.         
United States, California
Orthopaedic Surgery Specialists Recruiting
Burbank, California, United States, 91505
Principal Investigator: Shahan V Yacoubian, M.D.         
Sub-Investigator: Stephan V. Yacoubian, M.D.         
Orthopedic Specialists of North County Recruiting
Oceanside, California, United States, 92056
Principal Investigator: James Helgager, M.D.         
United States, Colorado
Colorado Orthopedic Consultants, PC Recruiting
Englewood, Colorado, United States, 80110
Principal Investigator: Jeffrey A. Arthur, D.O.         
United States, Florida
Coastal Orthopedics & Sports Medicine Withdrawn
Bradenton, Florida, United States, 34209
Institute for Orthopaedic Surgery and Sports Medicine Recruiting
Fort Myers, Florida, United States, 33919
Principal Investigator: George D. Markovich, M.D., FACS         
Mercy Hospital Withdrawn
Miami, Florida, United States, 33133
Florida Orthopaedic Institute Withdrawn
Temple Terrace, Florida, United States, 33637
United States, Maryland
OrthoMaryland Withdrawn
Baltimore, Maryland, United States, 21209
United States, Missouri
St. Peter's Bone & Joint Surgery Recruiting
St. Peters, Missouri, United States, 63376
Principal Investigator: John W. McAllister, M.D.         
United States, New Mexico
New Mexico Orthopedics Recruiting
Albuquerque, New Mexico, United States, 87106
Principal Investigator: Joshua T. Carothers, M.D.         
Sub-Investigator: Krishna R. Tripuraneni, M.D.         
United States, New York
NYU Hospital for Joint Diseases Not yet recruiting
New York, New York, United States, 10003
Principal Investigator: Claudette LaJam, M.D.         
United States, Texas
Texas Institute for Hip and Knee Surgery Recruiting
Austin, Texas, United States, 78751
Principal Investigator: David A. Dodgin, M.D.         
Sub-Investigator: Eric M. Heinrich, M.D.         
Sponsors and Collaborators
Encore Medical, L.P.
DJO Incorporated
  More Information

No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01551472     History of Changes
Other Study ID Numbers: PS-706
Study First Received: March 8, 2012
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014