Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Nancy Parks, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01140815
First received: May 28, 2010
Last updated: July 10, 2014
Last verified: July 2014

May 28, 2010
July 10, 2014
September 2007
May 2013   (final data collection date for primary outcome measure)
  • 2-Year Knee Society Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
  • 6-Week Knee Society Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
  • 4-Month Knee Society Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
  • 1-year Knee Society Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.
  • 2-Year Knee Society Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores.
  • 6-Week Knee Society Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores.
  • 4-Month Knee Society Score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores.
  • 1-year Knee Society Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores.
Complete list of historical versions of study NCT01140815 on ClinicalTrials.gov Archive Site
  • 6-Week X-rays [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.
  • 4-month X-rays [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.
  • 1-year X-rays [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.
  • 2-year X-rays [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.
  • 2-year Patient Surveys [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).
  • 6-week Functional Testing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
  • 4-month Functional Testing [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
  • 1-year Functional Testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
  • 2-year Functional Testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.
  • 6-Week x-rays [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities
  • 4-month X-rays [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities
  • 1-year x-rays [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities
  • 2-year X-rays [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities
  • 6-week Patient Surveys [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire and a patient satisfaction survey.
  • 4-month Patient Surveys [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire and a patient satisfaction survey.
  • 1-year Patient Surveys [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire and a patient satisfaction survey.
  • 2-year Patient Surveys [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire and a patient satisfaction survey.
  • 6-week Functional Testing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed.
  • 4-month Functional Testing [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed.
  • 1-year Functional Testing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed.
  • 2-year Functional Testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed.
Not Provided
Not Provided
 
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Arthroplasty
  • Device: Total Knee Replacement
    Smith and Nephew Total Knee Replacement
  • Device: Deuce
    Smith and Nephew Bicompartmental Knee Replacement
  • Active Comparator: Total
    The Smith and Nephew Total Knee System
    Intervention: Device: Total Knee Replacement
  • Experimental: Deuce
    The Journey Deuce Bicompartmental Knee System
    Intervention: Device: Deuce
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
  • Patient is 30 to 65 years of age, inclusive.
  • Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
  • Patient plans to be available for follow-up through 2 years postoperative.

Exclusion Criteria:

  • Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
  • Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
  • Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
  • Patient has BMI > 35.
  • Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
  • Patient has an active infection, local or systemic.
  • Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
  • Patient has ACL deficiency in the study knee.
  • Patient has hip arthritis and/or replacement.
  • Patient has lateral compartment disease.
  • Patient is pregnant or plans to become pregnant during the course of the study.
  • Patient is on workman's compensation.
  • Patient has a known sensitivity to materials in the device.
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01140815
AORI2010-0103
Yes
Nancy Parks, Anderson Orthopaedic Research Institute
Anderson Orthopaedic Research Institute
Smith & Nephew, Inc.
Principal Investigator: Gerard A. Engh, MD AORI
Anderson Orthopaedic Research Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP