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Scorpio® Cruciate Retaining (CR) Outcomes Study

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ClinicalTrials.gov Identifier: NCT00965146
Recruitment Status : Terminated (Terminated due to lagging follow-up.)
First Posted : August 25, 2009
Results First Posted : February 15, 2013
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Arthropathy of Knee Device: Scorpio® CR Total Knee System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 215 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Post-market, Non-randomized, Multi-center Study of the Outcomes of the Scorpio® Cruciate Retaining (CR) Total Knee System
Study Start Date : June 2001
Actual Primary Completion Date : July 23, 2009

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 Name: Scorpio® Cruciate Retaining (CR) Total Knee System




Primary Outcome Measures :
  1. Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings. [ Time Frame: 15 years ]
    This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

  2. Evaluate Complication Rate. [ Time Frame: 15 years ]
    This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965146


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

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00965146     History of Changes
Other Study ID Numbers: 48
First Posted: August 25, 2009    Key Record Dates
Results First Posted: February 15, 2013
Last Update Posted: November 17, 2017
Last Verified: April 2013

Keywords provided by Stryker Orthopaedics:
Osteoarthritis, traumatic arthritis, avascular necrosis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases