Arthrex Eclipse™ Shoulder Prosthesis

This study is currently recruiting participants.
Verified March 2014 by Arthrex, Inc.
Sponsor:
Information provided by (Responsible Party):
Arthrex, Inc.
ClinicalTrials.gov Identifier:
NCT01790113
First received: February 11, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.


Condition Intervention
Osteoarthritis
Device: Univers™
Device: Eclipse™ Total Shoulder Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease

Resource links provided by NLM:


Further study details as provided by Arthrex, Inc.:

Primary Outcome Measures:
  • Composite Clinical Success [ Time Frame: 2 year ] [ Designated as safety issue: No ]

    Composite of Clinical Success includes:

    1. constant score change of greater than 10
    2. Adjusted Constant Score greater than or equal to 54
    3. Radiographical Success: Patient meets acceptance criteria for humeral radiolucency, humeral migration/subsidence, glenoid radiolucency, glenoid migration/subsidence, device condition and periprosthetic fracture.


Estimated Enrollment: 350
Study Start Date: January 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Univer™ II
Univers™ II Total Shoulder Replacement
Device: Univers™
Control
Experimental: Eclipse™
Eclipse™ Total Shoulder Replacement
Device: Eclipse™ Total Shoulder Replacement
Investigational

Detailed Description:

The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is > 21 years of age
  2. The subject has continued symptoms in target shoulder despite at least 6 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections)
  3. The subject has a diagnosis in the target shoulder of one or more of the following: osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis.
  4. The subject presents with pain and functional impairment in the index shoulder, measured by an Adjusted Constant Score of ≤50. Note: The Adjusted Constant Score will be calculated from the raw Constant Score to establish patient eligibility.
  5. The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis.
  6. The subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study.
  7. The subject has been informed of the nature of the study and provided written consent as approved by the sites local Institutional Review Board or Ethic Review Board.

Exclusion Criteria:

  1. The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement.
  2. The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone.
  3. The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation.
  4. The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.
  5. The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.
  6. The subject has documented history of foreign-body sensitivity.
  7. Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period
  8. The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.
  9. The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.
  10. The subject is at high risk for poor healing or confounding outcomes [(i.e.: clinically significant/ being actively treated for renal, hepatic, cardiac hematologic disease or poorly controlled diabetes (HbA1c > 10 mg/dl)]
  11. The subject is on immune-stimulating or immunosuppressive agents
  12. The subject has co-morbidity that reduces life expectancy < 36 month.
  13. The subject seeking or receiving workman's compensation for shoulder injury,
  14. The subject is > 350 lbs
  15. The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)
  16. The subject has had surgery in the affected extremity in the last 12 months.
  17. The subject has disabilities of other joints that require pain management therapy.
  18. The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)
  19. The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids)
  20. The subject is a prisoners or wards of the state
  21. The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)
  22. The subject has an active or chronic infection, either systemic or local.
  23. The subject has pathologic fractures of the affected shoulder
  24. The subject has acute trauma of the affected shoulder
  25. The subject has osteoporosis defined as a bone density T score of < -2.5. (A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry)bone mineral density measurement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790113

Contacts
Contact: Melissa Hirschberg 239-216-1894 melissa.hirschberg@arthrex.com

Locations
United States, Arizona
Banner Research/The CORE Institute Not yet recruiting
Sun City, Arizona, United States, 85351
Contact: Bethany Larsen    623-537-5695    bethany.larsen@thecoreinstitute.com   
Principal Investigator: Arash Araghi, DO         
Sub-Investigator: John A Brown, MD         
United States, California
Orthopedics Stanford University School of Medicine Recruiting
Redwood City, California, United States, 94305
Contact: Elizabeth Handley    650-721-7614    ehandley@stanford.edu   
Principal Investigator: John Costouros, M.D.         
United States, Florida
Shands Hospital /University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Chris Koenig    352-273-7372    koenicj@ortho.ufl.edu   
Contact: MaryBeth Horodyski, EdD, ATC, LAT, FNATA    352-273-7074    horodmb@ortho.ufl.edu   
Principal Investigator: Kevin W Farmer, MD         
United States, Illinois
Rush Orthopaedics at Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60607
Contact: Mukesh Ahuja    312-563-2214    mahuja@rushortho.com   
Principal Investigator: Anthony Romeo, M.D.         
Sub-Investigator: Nikhil Verma, M.D.         
United States, Kentucky
Ellis and Badenhausen Orthopedics PSC Recruiting
Louisville, Kentucky, United States, 40223
Contact: Erin Gish    502-587-1236    Erin.Gish@Hotmail.com   
Principal Investigator: Mark Smith, M.D.         
United States, Maryland
Medstar Health Research Institute/Medstar Union Hospital Recruiting
Baltimore, Maryland, United States, 21237
Contact: Flossine Brown, BS    410-554-4451    Flossine.Brown@medstar.net   
Principal Investigator: Jason Stein, MD         
Peninsula Orthopaedics Associates, P.A. Recruiting
Salisbury, Maryland, United States, 21804
Contact: Trish Ireland    410-749-4154 ext 189    tireland@peninsulaortho.com   
Principal Investigator: Thomas A Brandon, M.D.         
United States, Minnesota
Essentia Health Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Robert J Shultz, RN    218-786-4126    rshultz@eirh.org   
Contact: Erica Chopskie       Erica.Chopskie@eirh.org   
Principal Investigator: Jeffery Klassen, MD         
United States, New York
Excelsior Orthopedics Foundation of WNY Recruiting
Amherst, New York, United States, 14226
Contact: Jamie Radtke    716-250-6494    JRadtke@excelsiorortho.com   
Contact: Annie Cumbo    716-250-6494    ACumbo@excelsiorortho.com   
Principal Investigator: Paul Patterson, M.D.         
SUNY Upstate Medical Universtiy Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig    315-464-8618    CraigT@upstate.edu   
Principal Investigator: Kevin Setter, M.D.         
United States, Ohio
Ahuja Medical Center University Hospital Not yet recruiting
Beachwood, Ohio, United States, 44122
Contact: Yousef Shishani    954-756-1011      
Principal Investigator: Rueben Gobezie, M.D.         
OhioHealth Research Institute at Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Lauren Allison, RN    614-566-8394    lalliso3@ohiohealth.com   
Contact: Jennifer Mull    614-566-8195    jmull2@ohiohealth.com   
Principal Investigator: Nathan Long, D.O.         
United States, Pennsylvania
Blair Orthopedic Associate, Inc Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Vicki Lassak    814-204-1191    vlassak@blairortho.com   
Principal Investigator: Joshua Port, MD         
United States, South Carolina
Providence Orthopaedics Group, LLC_Moore Orthopaedics Recruiting
Lexington, South Carolina, United States, 29072
Contact: Jay Patel, PhD    803-227-8582    jay.patel@moorecenter.com   
Contact: Greg Mangione, PA       greg.mangione@mooreclinic.com   
Principal Investigator: Earl McFadden, M.D.         
United States, Wisconsin
Midwest Orthopedic Speacility Hospital _Wheaton Franciscan Helathcare-Frankin Inc. Withdrawn
Franklin, Wisconsin, United States, 53132
Sponsors and Collaborators
Arthrex, Inc.
Investigators
Principal Investigator: Anthony Romeo, M.D. Midwest Orthopaedics at Rush University
  More Information

No publications provided

Responsible Party: Arthrex, Inc.
ClinicalTrials.gov Identifier: NCT01790113     History of Changes
Other Study ID Numbers: Arthrex 003
Study First Received: February 11, 2013
Last Updated: March 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Verapamil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014