Scorpio® Cruciate Retaining (CR) Outcomes Study

An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System

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

Study Overview

• Status: Terminated
• Conditions: Arthropathy of Knee
• Intervention / Treatment: Device: Scorpio® 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 Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Foundation for Musculoskeletal Research and Education
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Orthopaedic Research Foundation, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Physician Group
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • Dearborn Orthopaedics
  • New York
    • New York, New York, United States, 10021
      • Beth Israel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scorpio® CR Total Knee System; Scorpio® CR Total Knee System Study Device	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.; Other Names: Scorpio® Cruciate Retaining (CR) Total Knee System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Study Chair: C. Lowry Barnes, MD, Foundation for Musculoskeletal Research and Education; Principal Investigator: Lawrence Morawa, MD, Dearborn Orthopaedics; Principal Investigator: Arthur Malkani, MD, Jewish Physician Group; Principal Investigator: Frank Kolisek, MD, Orthopaedic Research Foundation, Inc.; Principal Investigator: Steven Harwin, MD, Beth Israel Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): July 23, 2009

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Osteoarthritis, traumatic arthritis, avascular necrosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 48