Arthrex Eclipse™ Shoulder Prosthesis

NCT ID: NCT01790113

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-04
• Study Completion Date: 2019-06-07

Brief Summary

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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Univer™ II

Univers™ II Total Shoulder Replacement

Group Type: ACTIVE_COMPARATOR

Univers™

Intervention Type: DEVICE

Control

Eclipse™

Eclipse™ Total Shoulder Replacement

Group Type: EXPERIMENTAL

Eclipse™ Total Shoulder Replacement

Intervention Type: DEVICE

Investigational

Interventions

Univers™

Control

Intervention Type: DEVICE

Eclipse™ Total Shoulder Replacement

Investigational

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Hirschberg

Role: STUDY_DIRECTOR

Arthrex, Inc.

Locations

Banner Research

Sun City, Arizona, United States

Orthopedics Stanford University

Redwood City, California, United States

Western Orthopaedics

Denver, Colorado, United States

Midwest Orthopaedics at Rush

Chicago, Illinois, United States

Ellis and Badenhausen Orthopedics PSC

Louisville, Kentucky, United States

Medstar Health Research Institute

Hyattsville, Maryland, United States

Peninsula Orthopaedics Associates, P.A.

Salisbury, Maryland, United States

Essentia Health Duluth

Duluth, Minnesota, United States

Excelsior Orthopedics

Amherst, New York, United States

SUNY Upstate Medical Universtiy

East Syracuse, New York, United States

Adena Health System

Chillicothe, Ohio, United States

OhioHealth Research Institute at Grant Medical Center

Columbus, Ohio, United States

Southern Oregon Orthopedics

Medford, Oregon, United States

University Orthopedics

Altoona, Pennsylvania, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics)

Columbia, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Arthrex 003

Identifier Type: -

Identifier Source: org_study_id