Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
Condition: Knee Arthroplasty
Intervention: Total Knee Replacement; Deuce
Intervention description: Smith and Nephew Total Knee Replacement; Smith and Nephew Bicompartmental Knee Replacement
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Total Knee Arthroplasty; Bicompartmental Knee Arthroplasty

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.
    

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.