Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
71 participants
INTERVENTIONAL
2006-10-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Primary
Post market study
3DKnee
Subjects with knee osteoarthritis and willing to participate in the study
Interventions
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3DKnee
Subjects with knee osteoarthritis and willing to participate in the study
Eligibility Criteria
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Inclusion Criteria
* Have knee joint disease related to one or more of the following
* degenerative joint disease, including osteoarthritis or traumatic arthritis
* Avascular necrosis of the femoral condyles
* Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
* Moderate valgus, varus, or flexion deformities
* Rheumatoid arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures
* Patient is not pregnant
* Patient must be over 18 years of age
Exclusion Criteria
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
* Is younger than 18 years of age
18 Years
ALL
No
Sponsors
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Encore Medical, L.P.
INDUSTRY
Responsible Party
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DJO Surgical
Principal Investigators
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John McAllister, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Peter's Bone and Joint Surgery
Locations
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St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, United States
Countries
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Related Links
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Sponsor Company home page
Other Identifiers
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PS - 703
Identifier Type: -
Identifier Source: org_study_id
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