Scorpio® Cruciate Retaining (CR) Outcomes Study

Not Applicable

Terminated

• Conditions: Arthropathy of Knee
• Interventions: Device: Scorpio® CR Total Knee System

• Registration Number: NCT00965146
• Lead Sponsor: Stryker Orthopaedics

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 commercially available and is intended for cemented use.

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.

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2009-07-23
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-25
• Results First Submitted: 2012-11-09
• Results First Submitted QC: 2013-02-12
• Results First Posted: 2013-02-15
• Status Verified: 2013-04
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

1. The subject is a male or non-pregnant female between the ages of 21-80.
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

1. Patient has inflammatory arthritis.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scorpio® CR Total Knee System	Scorpio® CR Total Knee System	Scorpio® CR Total Knee System Study Device

Primary Outcome Measures

Name	Time	Method
Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.	15 years	This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.
Evaluate Complication Rate.	15 years	This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

Trial Locations

Locations (5)

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

Foundation for Musculoskeletal Research and Education; 🇺🇸 Little Rock, Arkansas, United States