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Arthrex Eclipse™ Shoulder Prosthesis

This study is currently recruiting participants.
Verified November 2017 by Arthrex, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790113
First Posted: February 13, 2013
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Arthrex, Inc.
  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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

    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: October 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is > 21 years of age
  • The subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections)
  • 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.

  • 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.
  • The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis.
  • 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.
  • 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:

  • 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.
  • 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.
  • 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.
  • The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.
  • The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.
  • The subject has documented history of foreign-body sensitivity.
  • Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period
  • The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.
  • The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.
  • The subject is at high risk for poor healing or confounding outcomes [(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)]
  • The subject is on immune-stimulating or immunosuppressive agents
  • The subject has co-morbidity that reduces life expectancy < 36 month.
  • The subject seeking or receiving workman's compensation for shoulder injury,
  • The subject is > 350 lbs.
  • The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)
  • The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures)
  • The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)
  • The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers)
  • The subject is a prisoners or wards of the state
  • The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)
  • The subject has an active or chronic infection, either systemic or local.
  • The subject has pathologic fractures of the affected shoulder
  • The subject has acute trauma of the affected shoulder
  • The subject has osteoporosis defined as a bone density T score of < or = -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
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): NCT01790113


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

Locations
United States, Arizona
Banner Research/The CORE Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Susan Mauro    623-455-7125    susan.mauro@thecoreinstitute.com   
Principal Investigator: Arash Araghi, DO         
Sub-Investigator: John A Brown, MD         
United States, California
Orthopedics Stanford University School of Medicine Active, not recruiting
Redwood City, California, United States, 94305
United States, Colorado
Western Orthopaedics Recruiting
Denver, Colorado, United States, 80218
Contact: Libby Mauter       Libby.Mauter@gmail.com   
Contact: Jackie Bader       jbader@western-ortho.com   
Principal Investigator: Benjamin Sears, MD         
Sub-Investigator: Armodios Hatzidakis, MD         
United States, Florida
Shands Hospital /University of Florida Withdrawn
Gainesville, Florida, United States, 32611
United States, Illinois
Rush Orthopaedics at Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60607
United States, Kentucky
Ellis and Badenhausen Orthopedics PSC Terminated
Louisville, Kentucky, United States, 40223
United States, Maryland
Medstar Health Research Institute/Medstar Union Hospital Terminated
Baltimore, Maryland, United States, 21237
Peninsula Orthopaedics Associates, P.A. Active, not recruiting
Salisbury, Maryland, United States, 21804
United States, Minnesota
Essentia Health Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Robert J Shultz, RN    218-786-4126    rshultz@eirh.org   
Principal Investigator: Jeffery Klassen, MD         
United States, New York
Excelsior Orthopedics Foundation of WNY Terminated
Amherst, New York, United States, 14226
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
Adena Bone & Joint Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Samantha K Johnson       sjohnson6@adena.org   
Principal Investigator: Brian Cohen, MD         
Sub-Investigator: Scott Shemory, MD         
OhioHealth Research Institute at Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: Beth Archer    614-566-8394    Beth.Archer@ohiohealth.com   
Contact: Elizabeth Ferguson    614-566-9783    Elizabeth.Ferguson@ohiohealth.com   
Principal Investigator: Nathan Long, D.O.         
United States, Pennsylvania
University Orthopedics Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Penny S Adams    814-944-4532    padams@blairortho.com   
Contact: Martina Synder    814-204-1191    msnyder@blairortho.com   
Principal Investigator: Joshua Port, MD         
Sub-Investigator: William Tyndall, MD         
Rothman Institute Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics) Terminated
Lexington, South Carolina, United States, 29072
Sponsors and Collaborators
Arthrex, Inc.
Investigators
Principal Investigator: Anthony Romeo, M.D. Midwest Orthopaedics at Rush University
  More Information

Responsible Party: Arthrex, Inc.
ClinicalTrials.gov Identifier: NCT01790113     History of Changes
Other Study ID Numbers: Arthrex 003
First Submitted: February 11, 2013
First Posted: February 13, 2013
Last Update Posted: November 21, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases