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CompletedNCT01390038Updated Apr 25, 2023Results posted

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

A Phase 3 interventional study of Simpliciti™ Shoulder System in Primary Generalized (Osteo)Arthritis and Post-traumatic Arthrosis of Other Joints, Upper Arm, sponsored by Stryker Trauma and Extremities. Completed at 14 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Stryker Trauma and Extremities · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
157
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Primary Generalized (Osteo)Arthritis
  • Post-traumatic Arthrosis of Other Joints, Upper Arm

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 157 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
157 participants (actual)

Study arms

  • Experimental
    Simpliciti™ Shoulder System

    The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.

    Device: Simpliciti™ Shoulder System

Interventions

  • DeviceSimpliciti™ Shoulder System

    Total shoulder arthroplasty system

06

What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. Quality of Life

    Simple Shoulder Test 1 (worse) - 12 (best)

    Time frame: 24 months

  2. Range of Motion

    * Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side

    Time frame: 24 months

  3. Strength

    Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier

    Time frame: 24 months

  4. Device Parameters

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

    Time frame: 24 months

  5. American Shoulder and Elbow Surgeon Score

    0 (worst) - 100 (best)

    Time frame: 24 Months

  6. Pain: Visual Analog Scale

    0 (best) - 10 (worst)

    Time frame: 24 Months

07

Results

Posted Apr 14, 2016

Participant flow

Participant flow — Overall Study
MilestoneSimpliciti™ Shoulder System
Started157
Completed149
Not completed8
Withdrew: Death1
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject4
Withdrew: Simpliciti system removal2

Outcome measures

PrimaryDevice 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.

Time frame:
24 months
Reported as:
Number · participants
Device Success Rate
participantsSimpliciti™ Shoulder System
Device Success Rate134
SecondaryQuality of Life

Simple Shoulder Test 1 (worse) - 12 (best)

Time frame:
24 months
Reported as:
Mean · units on a scale
Quality of Life
units on a scaleSimpliciti™ Shoulder System
Quality of Life10.8 ± 1.7
SecondaryRange of Motion

* Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side

Time frame:
24 months
Reported as:
Mean · Degrees
Range of Motion
DegreesSimpliciti™ Shoulder System
Elevation in the Scapular Plan146.6 ± 23.7
Internal Rotation73.9 ± 1635
External Rotation56.4 ± 15.4
SecondaryStrength

Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier

Time frame:
24 months
Reported as:
Mean · Pounds
Strength
PoundsSimpliciti™ Shoulder System
Strength15.7 ± 7.8
SecondaryDevice Parameters

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

Time frame:
24 months
Reported as:
Number · Percentage of participants
Device Parameters
Percentage of participantsSimpliciti™ Shoulder System
Migration0
Osteolysis0
Subsidence0
SecondaryAmerican Shoulder and Elbow Surgeon Score

0 (worst) - 100 (best)

Time frame:
24 Months
Reported as:
Mean · units on a scale
American Shoulder and Elbow Surgeon Score
units on a scaleSimpliciti™ Shoulder System
American Shoulder and Elbow Surgeon Score91.9 ± 11.4
SecondaryPain: Visual Analog Scale

0 (best) - 10 (worst)

Time frame:
24 Months
Reported as:
Mean · units on a scale
Pain: Visual Analog Scale
units on a scaleSimpliciti™ Shoulder System
Pain: Visual Analog Scale0.5 ± 1.2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Simpliciti™ Shoulder System—4/157 (2.5%)51/157 (32.5%)
Most frequent serious events
Most frequent serious events
EventSimpliciti™ Shoulder System
Aseptic Glenoid LooseningMusculoskeletal and connective tissue disorders1/157
Arthrofibrosis, treated shoulderMusculoskeletal and connective tissue disorders1/157
InfectionInfections and infestations1/157
WeaknessMusculoskeletal and connective tissue disorders1/157
Most frequent other events
Most frequent other events
EventSimpliciti™ Shoulder System
OsteoarthritisMusculoskeletal and connective tissue disorders39/157
PainMusculoskeletal and connective tissue disorders12/157

Baseline characteristics

Age, Continuous
Age, Continuous(years)Simpliciti™ Shoulder System
Mean65.5 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Simpliciti™ Shoulder System
Female45
Male112
08

Study locations

14 sites
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01390038
Lead sponsor
Stryker Trauma and Extremities
Responsible party
Sponsor
First posted
Jul 8, 2011
Start date
Jul 2011
Primary completion
Nov 2014
Completion
Dec 2014
Results posted
Apr 14, 2016
Last update
Apr 25, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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