Scorpio® Cruciate Retaining (CR) Outcomes Study

This study has been terminated.
(Terminated due to lagging follow-up.)
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00965146
First received: August 11, 2009
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Arthropathy of Knee
Device: Scorpio® CR Total Knee System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings. [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.

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


Enrollment: 215
Study Start Date: June 2001
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00965146     History of Changes
Other Study ID Numbers: 48
Study First Received: August 11, 2009
Results First Received: November 9, 2012
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 01, 2014