Arthrex Eclipse™ Shoulder Prosthesis

NCT01790113 | Terminated Results

• 1 other identifier: Arthrex 003
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 16

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Composite Clinical Success

  To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. 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. 2. 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. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.

  2 year

Study Arms (2)

Univer™ II

ACTIVE COMPARATOR

Univers™ II Total Shoulder Replacement

Device: Univers™

Eclipse™

EXPERIMENTAL

Eclipse™ Total Shoulder Replacement

Device: Eclipse™ Total Shoulder Replacement

Interventions

Univers™ DEVICE

Control

Univer™ II

Eclipse™ Total Shoulder Replacement DEVICE

Investigational

Eclipse™

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (16)

Banner Research

Sun City, Arizona, 85351, United States

Location

Orthopedics Stanford University

Redwood City, California, 94063, United States

Location

Western Orthopaedics

Denver, Colorado, 80218, United States

Location

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

Ellis and Badenhausen Orthopedics PSC

Louisville, Kentucky, 40223, United States

Location

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Peninsula Orthopaedics Associates, P.A.

Salisbury, Maryland, 21804, United States

Location

Essentia Health Duluth

Duluth, Minnesota, 55805, United States

Location

Excelsior Orthopedics

Amherst, New York, 14226, United States

Location

SUNY Upstate Medical Universtiy

East Syracuse, New York, 13057, United States

Location

Adena Health System

Chillicothe, Ohio, 45601, United States

Location

OhioHealth Research Institute at Grant Medical Center

Columbus, Ohio, 43215, United States

Location

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

University Orthopedics

Altoona, Pennsylvania, 16602, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19108, United States

Location

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

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Clinical Affairs Manager
• Organization: Arthrex

melissa.hirschberg@arthrex.com

2392161894

Study Officials

• Melissa Hirschberg

  Arthrex, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: February 4, 2013
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: February 3, 2021
• Results First Posted: January 29, 2021

Record last verified: 2019-10

Locations

US (16)