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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
  Purpose

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.


Condition Intervention Phase
Knee Arthroplasty
Device: Total Knee Replacement
Device: Deuce
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System

Resource links provided by NLM:


Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: September 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Total
The Smith and Nephew Total Knee System
Device: Total Knee Replacement
Smith and Nephew Total Knee Replacement
Experimental: Deuce
The Journey Deuce Bicompartmental Knee System
Device: Deuce
Smith and Nephew Bicompartmental Knee Replacement

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01140815

Locations
United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22307
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
Smith & Nephew, Inc.
Investigators
Principal Investigator: Gerard A. Engh, MD AORI
  More Information

No publications provided

Responsible Party: Nancy Parks, Knee Project Director, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01140815     History of Changes
Other Study ID Numbers: AORI2010-0103
Study First Received: May 28, 2010
Results First Received: November 25, 2013
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
Total Knee Arthroplasty
Bicompartmental Knee Arthroplasty

ClinicalTrials.gov processed this record on November 20, 2014