Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
215 participants
INTERVENTIONAL
2001-06-30
Brief Summary
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Detailed Description
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The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.
Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.
The objectives of this study are to:
1. Evaluate the effect of system component design on functional performance.
2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
3. Evaluate complications and the rates in which they occur.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Scorpio® CR Total Knee System
Scorpio® CR Total Knee System Study Device
Scorpio® CR Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
Interventions
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Scorpio® CR Total Knee System
All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria
2. The subject is morbidly obese, \>60% over ideal body weight for frame and height.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
6. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements.
8. The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
9. The subject has had a knee fusion to the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.
12. The subject is pregnant.
21 Years
80 Years
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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C. Lowry Barnes, MD
Role: STUDY_CHAIR
Foundation for Musculoskeletal Research and Education
Lawrence Morawa, MD
Role: PRINCIPAL_INVESTIGATOR
Dearborn Orthopaedics
Arthur Malkani, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish Physician Group
Frank Kolisek, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Research Foundation, Inc.
Steven Harwin, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Medical Center
Locations
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Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, United States
Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, United States
Jewish Physician Group
Louisville, Kentucky, United States
Dearborn Orthopaedics
Dearborn, Michigan, United States
Beth Israel Medical Center
New York, New York, United States
Countries
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Other Identifiers
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48
Identifier Type: -
Identifier Source: org_study_id