Arthrex Eclipse™ Shoulder Prosthesis

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Device: Univers™; Device: Eclipse™ Total Shoulder Replacement

• Registration Number: NCT01790113
• Lead Sponsor: Arthrex, Inc.

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.

Study Timeline

• Study Start: 2013-02-04
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-13
• Primary Completion: 2019-06-07
• Study Completion: 2019-06-07
• Status Verified: 2019-10
• Results First Submitted: 2019-12-13
• Results First Submitted QC: 2021-01-11
• Results First Posted: 2021-01-29
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 303

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Univer™ II	Univers™	Univers™ II Total Shoulder Replacement
Eclipse™	Eclipse™ Total Shoulder Replacement	Eclipse™ Total Shoulder Replacement

Primary Outcome Measures

Name	Time	Method
Composite Clinical Success	2 year	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.

Trial Locations

Locations (16)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Western Orthopaedics; 🇺🇸 Denver, Colorado, United States

Orthopedics Stanford University; 🇺🇸 Redwood City, California, United States

Banner Research; 🇺🇸 Sun City, Arizona, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Peninsula Orthopaedics Associates, P.A.; 🇺🇸 Salisbury, Maryland, United States

SUNY Upstate Medical Universtiy; 🇺🇸 East Syracuse, New York, United States

Essentia Health Duluth; 🇺🇸 Duluth, Minnesota, United States

Medstar Health Research Institute; 🇺🇸 Hyattsville, Maryland, United States

Excelsior Orthopedics; 🇺🇸 Amherst, 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

Palmetto Health Orthopedics (formerly Providence Orthopedics Group, LLC_Moore Orthopedics); 🇺🇸 Columbia, South Carolina, United States

Ellis and Badenhausen Orthopedics PSC; 🇺🇸 Louisville, Kentucky, United States