Status:
COMPLETED
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
Lead Sponsor:
Anderson Orthopaedic Research Institute
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Knee Arthroplasty
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
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 replace...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01140815
Start Date
September 1 2007
End Date
May 1 2013
Last Update
August 4 2014
Active Locations (1)
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1
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22307