Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
1 other identifier
interventional
157
1 country
14
Brief Summary
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2011
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
April 14, 2016
CompletedApril 25, 2023
April 1, 2023
3.3 years
May 26, 2011
February 16, 2016
April 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Device Success Rate
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 Outcomes (6)
Quality of Life
24 months
Range of Motion
24 months
Strength
24 months
Device Parameters
24 months
American Shoulder and Elbow Surgeon Score
24 Months
- +1 more secondary outcomes
Study Arms (1)
Simpliciti™ Shoulder System
EXPERIMENTALThe Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Lack of sufficient sound bone to seat and support the implant such as:
- Rapid joint destruction, marked bone loss or bone resorption;
- Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and
- 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:
- Glenohumeral joint infection
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Saint Agnes Medical Center
Fresno, California, 93720, United States
Grossmont/Sharp Hospital
La Mesa, California, 91942, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Rush Hospital
Chicago, Illinois, 60612, United States
Beverly Hills Orthopaedic Surgery
Beverly Hills, Michigan, 48025, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Sports and Orthopaedic Specialists
Edina, Minnesota, 55439, United States
University of Missouri-Columbia
Columbia, Missouri, 65212, United States
Bassett Healthcare Network Research Institute
Cooperstown, New York, 13326, United States
Cleveland Clinic
Euclid, Ohio, 44119, United States
The Center
Bend, Oregon, 97701, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37917, United States
Aurora Medical Center - Grafton
Grafton, Wisconsin, 53024, United States
Results Point of Contact
- Title
- Josh Myers
- Organization
- Tornier/Wright Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
July 8, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
April 25, 2023
Results First Posted
April 14, 2016
Record last verified: 2023-04