Scorpio® Cruciate Retaining (CR) Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthropathy of Knee

In brief

The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.

Key facts

Study ID

NCT00965146

Run by

Stryker Orthopaedics

People needed

215

Starts

2001-06-01

Last updated by the study team

2017-11-17

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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