Phase 4
N=50
Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System
Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT01140815 ↗Enrolled (actual)
50
Serious AEs
8.0%
Results posted
Aug 2014
Primary outcome: Primary: 2-Year Knee Society Score — 91.3; 94.2 units on a scale 0-100
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Total Knee Replacement (Device); Deuce (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Anderson Orthopaedic Research Institute
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-Year Knee Society Score |
91.3; 94.2 | — |
| PRIMARY 6-Week Knee Society Score |
75; 83.3 | — |
| PRIMARY 4-Month Knee Society Score |
87.1; 91.3 | — |
| PRIMARY 1-year Knee Society Score |
88.6; 91.7 | — |
| SECONDARY 6-Week X-rays |
0; 0 | — |
| SECONDARY 4-month X-rays |
0; 0 | — |
| SECONDARY 1-year X-rays |
2; 3 | — |
| SECONDARY 2-year X-rays |
6; 4 | — |
| SECONDARY 2-year Patient Surveys |
41; 43 | — |
| SECONDARY 6-week Functional Testing |
36.5; 35.1 | — |
| SECONDARY 4-month Functional Testing |
25.5; 26.7 | — |
| SECONDARY 1-year Functional Testing |
25; 23.9 | — |
| SECONDARY 2-year Functional Testing |
25.1; 23.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01140815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.