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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System

Conditions
-----------------
Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Total Knee Replacement
* Device: Deuce


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total<br>The Smith and Nephew Total Knee System | Device: Total Knee Replacement<br>* Smith and Nephew Total Knee Replacement<br>|
| Experimental: Deuce<br>The Journey Deuce Bicompartmental Knee System | Device: Deuce<br>* Smith and Nephew Bicompartmental Knee Replacement<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty, Bicompartmental Knee Arthroplasty