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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Device: Total Knee Replacement; Device: Deuce

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Alexandria, Virginia, United States, 22307
      • Anderson Orthopaedic Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Year Knee Society Score	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 years
6-Week Knee Society Score	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 weeks
4-Month Knee Society Score	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 months
1-year Knee Society Score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Week X-rays	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.	6 weeks
4-month X-rays	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.	4 months
1-year X-rays	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.	1 year
2-year X-rays	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 years
2-year Patient Surveys	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).	2 years
6-week Functional Testing	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 weeks
4-month Functional Testing	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 months
1-year Functional Testing	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
2-year Functional Testing	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 years

Collaborators and Investigators

• Sponsor: Anderson Orthopaedic Research Institute
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Gerard A. Engh, MD, AORI

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (ESTIMATE): June 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 4, 2014
• Last Update Submitted That Met QC Criteria: July 10, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Bicompartmental Knee Arthroplasty
• Other Study ID Numbers: AORI2010-0103