NCT01704326CompletedNot Applicable
A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 59
- Locations
- 4
- Primary Endpoint
- Change in Knee Society Score
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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.
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 greater than or equal to
- •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.
Outcomes
Primary Outcomes
Change in Knee Society Score
Time Frame: Preoperative-2 years
Assess knee pain, function and range of motion using the Knee Society Clinical Rating System
Secondary Outcomes
- Patient Satisfaction(6 weeks, 3 months, 6 months, 1 year and 2 years)
- Oxford Knee Outcome Questionnaire(Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years)
- Radiographic Evaluation(6 weeks, 1 year and 2 years)
- Adverse Events(When Necessary)
Investigators
Study Sites (4)
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