Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty

April 21, 2023 updated by: Stryker Trauma GmbH

Simpliciti IDE Trial

The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93720
        • Saint Agnes Medical Center
      • La Mesa, California, United States, 91942
        • Grossmont/Sharp Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Hospital
    • Michigan
      • Beverly Hills, Michigan, United States, 48025
        • Beverly Hills Orthopaedic Surgery
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Edina, Minnesota, United States, 55439
        • Sports and Orthopaedic Specialists
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Network Research Institute
    • Ohio
      • Euclid, Ohio, United States, 44119
        • Cleveland Clinic
    • Oregon
      • Bend, Oregon, United States, 97701
        • The Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Knoxville Orthopaedic Clinic
    • Wisconsin
      • Grafton, Wisconsin, United States, 53024
        • Aurora Medical Center - Grafton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult subject 22 years or older
  • Clinical indication for total shoulder replacement due to primary diagnosis of arthritis. Primary arthritis for this study includes osteoarthritis, and/or traumatic arthritis.
  • Scapula and proximal humerus must have reached skeletal maturity
  • Subject with a Constant Score ≥ 20
  • Willing and able to comply with the protocol
  • Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)

Exclusion Criteria:

  • Lack of sufficient sound bone to seat and support the implant such as:

    1. Rapid joint destruction, marked bone loss or bone resorption;
    2. Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
    3. Osteomalacia
  • Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene

  • Infection at or near the site of implantation, including:

    1. Glenohumeral joint infection
    2. Osteomyelitis
  • Distant or systemic infection
  • Medical conditions or balance impairments that could lead to falls
  • Prior open shoulder surgery on the shoulder to be treated in the study including failed rotator cuff surgery, but excluding successful shoulder arthroscopy
  • Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff
  • Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery
  • Metabolic disorders which may impair bone function
  • Nonfunctional deltoid muscle
  • Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint)
  • Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease
  • Currently, or within the last 6 months, or planning to be on chemotherapy or radiation
  • Currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
  • Female subjects who are pregnant or planning to become pregnant within the study period
  • In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice
  • History of any cognitive or mental health status that would interfere with study participation
  • Alcohol or drug abuse
  • Engages in manual labor or sports activities that could affect shoulder outcome
  • Currently enrolled in any clinical research study that might interfere with the current study endpoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Simpliciti™ Shoulder System
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Device: Simpliciti™ Shoulder System
Total shoulder arthroplasty system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Success Rate
Time Frame: 24 months

A subject is a Patient Success at 24-months if:

  1. There is NO continuous radiolucent line around the prosthesis; and
  2. The adjusted Constant Score is > 85 (successful outcome); and
  3. They did not have revision surgery; and
  4. They did not have a system-related serious adverse event.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 24 months

Simple Shoulder Test

1 (worse) - 12 (best)
24 months
Range of Motion
Time Frame: 24 months
  • Elevation in the scapula plane
  • Internal rotation with arm at the side
  • External rotation with arm at the side
24 months
Strength
Time Frame: 24 months
Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier
24 months
Device Parameters
Time Frame: 24 months

Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:

  • Migration
  • Osteolysis
  • Subsidence
24 months
American Shoulder and Elbow Surgeon Score
Time Frame: 24 Months
0 (worst) - 100 (best)
24 Months
Pain: Visual Analog Scale
Time Frame: 24 Months
0 (best) - 10 (worst)
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Trauma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G100284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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