Status:
TERMINATED
Scorpio® Cruciate Retaining (CR) Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthropathy of Knee
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.
Detailed Description
The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercial...
Eligibility Criteria
Inclusion
- The subject is a male or non-pregnant female between the ages of 21-80.
- The subject requires a primary cemented total knee replacement.
- The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- The subject has intact collateral ligaments.
- The subject has signed the IRB approved, study specific Informed Patient Consent Form.
- The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion
- Patient has inflammatory arthritis.
- The subject is morbidly obese, \>60% over ideal body weight for frame and height.
- The subject has a history of total or unicompartmental reconstruction of the affected joint.
- Patient has had a high tibial osteotomy or femoral osteotomy.
- The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements.
- The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- The subject has had a knee fusion to the affected joint.
- The subject has an active or suspected latent infection in or about the knee joint.
- The subject is a prisoner.
- The subject is pregnant.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00965146
Start Date
June 1 2001
Last Update
November 17 2017
Active Locations (5)
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1
Foundation for Musculoskeletal Research and Education
Little Rock, Arkansas, United States, 72205
2
Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana, United States, 46237
3
Jewish Physician Group
Louisville, Kentucky, United States, 40202
4
Dearborn Orthopaedics
Dearborn, Michigan, United States, 48124