A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
NCT ID: NCT01704326
Last Updated: 2012-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2006-09-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
75 Years
ALL
Yes
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Locations
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Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States
Orthopaedic Surgery Specialists, Ltd.
Park Ridge, Illinois, United States
Henry County Center for Orthopedic Surgery & Sports Medicine
New Castle, Indiana, United States
Iowa Orthopaedic Center, PC
Des Moines, Iowa, United States
Countries
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Other Identifiers
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DEUK01
Identifier Type: -
Identifier Source: org_study_id