A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.
Condition or disease
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.
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Layout table for eligibility information
Ages Eligible for Study:
30 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.
Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
Patient is 30 to 75 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 five years postoperative.
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 greater than or equal to 40.
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 followup (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 has a known sensitivity to materials in the device.