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OsteoarthritisNCT01790113

Arthrex Eclipse™ Shoulder Prosthesis

A study testing Univers™ and Eclipse™ Total Shoulder Replacement in people with Osteoarthritis, run by Arthrex, Inc. at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Univers™ and Eclipse™ Total Shoulder Replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
16 sitesUnited States
Study dates
4 Feb 2013to 7 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University Orthopedics

    Altoona, Pennsylvania, 16602

  • Excelsior Orthopedics

    Amherst, New York, 14226

  • Midwest Orthopaedics at Rush

    Chicago, Illinois, 60612

  • Adena Health System

    Chillicothe, Ohio, 45601

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

    Columbia, South Carolina, 29203

  • OhioHealth Research Institute at Grant Medical Center

    Columbus, Ohio, 43215

  • Western Orthopaedics

    Denver, Colorado, 80218

  • Essentia Health Duluth

    Duluth, Minnesota, 55805

  • SUNY Upstate Medical Universtiy

    East Syracuse, New York, 13057

  • Medstar Health Research Institute

    Hyattsville, Maryland, 20782

  • Ellis and Badenhausen Orthopedics PSC

    Louisville, Kentucky, 40223

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504

  • Rothman Institute

    Philadelphia, Pennsylvania, 19108

  • Orthopedics Stanford University

    Redwood City, California, 94063

  • Peninsula Orthopaedics Associates, P.A.

    Salisbury, Maryland, 21804

  • Banner Research

    Sun City, Arizona, 85351

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Univers™, Eclipse™ Total Shoulder Replacement
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Univers™Device

    Control

  • Eclipse™ Total Shoulder ReplacementDevice

    Investigational

Study groups in NCT01790113
Study groupRoleWhat they receive
Univer™ IIActive comparatorUnivers™ II Total Shoulder Replacement
Receives: Device: Univers™
Eclipse™ExperimentalEclipse™ Total Shoulder Replacement
Receives: Device: Eclipse™ Total Shoulder Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study start4 Feb 2013
  3. Primary completion7 Jun 2019
  4. Study completion7 Jun 2019

Why it stopped: Eclipse Shoulder System received 510(k) clearance on July 26, 2019.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790113
Sponsor's protocol ID
Arthrex 003
Status last verified
Oct 2019
First submitted
11 Feb 2013
Last updated
3 Feb 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Univers™ and Eclipse™ Total Shoulder Replacement in people with Osteoarthritis, run by Arthrex, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Clinical Success (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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Arthrex Eclipse™ Shoulder Prosthesis (NCT01790113) | AzTrials