Clinical trial NCT01140815: Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
Official title: A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Bicompartmental Knee Arthroplasty
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2010-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 2-Year Knee Society Score
timeFrame: 2 years
measure: 6-Week Knee Society Score
timeFrame: 6 weeks
measure: 4-Month Knee Society Score
timeFrame: 4 months
measure: 1-year Knee Society Score
timeFrame: 1 year
Secondary outcomes:
measure: 6-Week X-rays
timeFrame: 6 weeks
measure: 4-month X-rays
timeFrame: 4 months
measure: 1-year X-rays
timeFrame: 1 year
measure: 2-year X-rays
timeFrame: 2 years
measure: 2-year Patient Surveys
timeFrame: 2 years
measure: 6-week Functional Testing
timeFrame: 6 weeks
measure: 4-month Functional Testing
timeFrame: 4 months
measure: 1-year Functional Testing
timeFrame: 1 year
measure: 2-year Functional Testing
timeFrame: 2 years
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
affiliation: AORI
name: Gerard A. Engh, MD
role: PRINCIPAL_INVESTIGATOR
References: