Primary Generalized (Osteo)ArthritisPhase 3NCT01390038
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
A Phase 3 study testing Simpliciti™ Shoulder System in people with Primary Generalized (Osteo)Arthritis and Post-traumatic Arthrosis of Other Joints, Upper Arm, run by Stryker Trauma and Extremities at 14 sites in United States.
Trial summary
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Generalized (Osteo)Arthritis, Post-traumatic Arthrosis of Other Joints, Upper Arm
- What is being tested?
- Simpliciti™ Shoulder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2011to Dec 2014
- Phase
- Phase 3
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 25Show fewer
- 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
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
The Center
Bend, Oregon, 97701
Beverly Hills Orthopaedic Surgery
Beverly Hills, Michigan, 48025
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush Hospital
Chicago, Illinois, 60612
University of Missouri-Columbia
Columbia, Missouri, 65212
Bassett Healthcare Network Research Institute
Cooperstown, New York, 13326
Sports and Orthopaedic Specialists
Edina, Minnesota, 55439
Cleveland Clinic
Euclid, Ohio, 44119
Saint Agnes Medical Center
Fresno, California, 93720
Aurora Medical Center - Grafton
Grafton, Wisconsin, 53024
Knoxville Orthopaedic Clinic
Knoxville, Tennessee, 37917
Grossmont/Sharp Hospital
La Mesa, California, 91942
Yale University School of Medicine
New Haven, Connecticut, 06520
Munson Medical Center
Traverse City, Michigan, 49684
About this study
Official title: Simpliciti IDE Trial
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
- Being tested
- Simpliciti™ Shoulder System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simpliciti™ Shoulder SystemDevice
Total shoulder arthroplasty system
| Study group | Role | What they receive |
|---|---|---|
| Simpliciti™ Shoulder System | Experimental | The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. Receives: Device: Simpliciti™ Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
A subject is a Patient Success at 24-months if:
- There is NO continuous radiolucent line around the prosthesis; and
- The adjusted Constant Score is > 85 (successful outcome); and
- They did not have revision surgery; and
- They did not have a system-related serious adverse event.
Measured: 24 months
Secondary outcomes (6)
Quality of Life
Simple Shoulder Test
1 (worse) - 12 (best)
Measured: 24 months
Range of Motion
- Elevation in the scapula plane
- Internal rotation with arm at the side
- External rotation with arm at the side
Measured: 24 months
Strength
Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier
Measured: 24 months
Device Parameters
Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:
- Migration
- Osteolysis
- Subsidence
Measured: 24 months
American Shoulder and Elbow Surgeon Score
0 (worst) - 100 (best)
Measured: 24 Months
Pain: Visual Analog Scale
0 (best) - 10 (worst)
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Generalized (Osteo)ArthritisStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390038
- Sponsor's protocol ID
- G100284
- Status last verified
- Apr 2023
- First submitted
- 26 May 2011
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simpliciti IDE Trial
- ClinicalTrials.gov ID
- NCT01390038
- Acronym / sponsor ID
- G100284
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 14 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simpliciti™ Shoulder System | Experimental | Device: Simpliciti™ Shoulder SystemThe Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- Lack of sufficient sound bone to seat and support the implant such as:
- 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:
- Distant or systemic infection
- Medical conditions or balance impairments that could lead to falls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simpliciti™ Shoulder SystemTotal shoulder arthroplasty system | Device | Simpliciti™ Shoulder System |
Primary outcome
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.
6 secondary outcomes
Quality of Life
Time frame: 24 months
Range of Motion
Time frame: 24 months
Strength
Time frame: 24 months
Device Parameters
Time frame: 24 months
American Shoulder and Elbow Surgeon Score
Time frame: 24 Months
Pain: Visual Analog Scale
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simpliciti™ Shoulder System in people with Primary Generalized (Osteo)Arthritis and Post-traumatic Arthrosis of Other Joints, Upper Arm, run by Stryker Trauma and Extremities at 14 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 6 inclusion and 25 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: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2016). 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?
Device Success Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.