Arthrex Eclipse™ Shoulder Prosthesis

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Univers™; Device: Eclipse™ Total Shoulder Replacement

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.

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Research
  • California
    • Redwood City, California, United States, 94063
      • Orthopedics Stanford University
  • Colorado
    • Denver, Colorado, United States, 80218
      • Western Orthopaedics
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopaedics at Rush
  • Kentucky
    • Louisville, Kentucky, United States, 40223
      • Ellis and Badenhausen Orthopedics PSC
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Medstar Health Research Institute
    • Salisbury, Maryland, United States, 21804
      • Peninsula Orthopaedics Associates, P.A.
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Duluth
  • New York
    • Amherst, New York, United States, 14226
      • Excelsior Orthopedics
    • East Syracuse, New York, United States, 13057
      • SUNY Upstate Medical Universtiy
  • Ohio
    • Chillicothe, Ohio, United States, 45601
      • Adena Health System
    • Columbus, Ohio, United States, 43215
      • OhioHealth Research Institute at Grant Medical Center
  • Oregon
    • Medford, Oregon, United States, 97504
      • Southern Oregon Orthopedics
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • University Orthopedics
    • Philadelphia, Pennsylvania, United States, 19108
      • Rothman Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics)

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Univer™ II; Univers™ II Total Shoulder Replacement	Device: Univers™; Control
Experimental: Eclipse™; Eclipse™ Total Shoulder Replacement	Device: Eclipse™ Total Shoulder Replacement; Investigational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Clinical Success	To be considered a success, the eclipse subject must meet the following composite clinical success criteria: An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is > or = to 10 and a final Adjusted Constant Score > or + to 54.; Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol.; No reoperation, removal or modification of any study component up to the subject's completion of the study.; No serious device-related complications up to the subject's completion of the study.	2 year

Collaborators and Investigators

• Sponsor: Arthrex, Inc.
• Investigators: Study Director: Melissa Hirschberg, Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2013
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Arthrex 003