Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
258 participants
INTERVENTIONAL
2013-08-31
2019-09-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
NCT03726554
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
NCT02452957
Sidus Stem-Free Shoulder IDE Study
NCT01878253
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
NCT01390038
Patient Reported Outcome After Stemmed Versus Stemless Total Shoulder Arthroplasty for Glenohumeral Osteoarthritis.
NCT03877315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. American Shoulder and Elbow Surgeons (ASES) Score
2. Single Assessment Numeric Evaluation (SANE)
3. Constant Score
4. Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence
5. Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Comprehensive Mini Humeral Stem
The Comprehensive® Shoulder System with mini stem component, which will be the control device for this clinical investigation and was 510(k) cleared under K060692 on May 30, 2006.
The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
Mini Stem
The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
Comprehensive Nano Humeral Component
The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
Nano
The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mini Stem
The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
Nano
The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with non-inflammatory degenerative joint disease including osteoarthritis.
* Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint)
* Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful.
* Patients requiring unilateral or staged bilateral shoulder arthroplasty
* Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact).
* Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity.
* Patients with an ASES score ≤ 40.
Exclusion Criteria
* Patients found at the time of intraoperative examination to have a single cyst \>1 cm in size or multiple cysts at the implantation site
* Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site.
* Patients with cuff tear arthropathy.
* Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
* Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
* Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing.
* Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram.
* Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions.
* Bone cancer, either primary or secondary, that affects the shoulder.
* Patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
* Patients with a life expectancy of less than three years.
* Patients diagnosed with severe shoulder instability
* Patients diagnosed with subscapularis incompetence
* Patients diagnosed with any condition that may limit their ability to complete the consent form or would affect their capability or willingness to return to the clinic for assessments and/or follow directions (i.e. mental illness)
* Patients with known metal allergy
* Patients who refuse to sign the Institutional Review Board (IRB) approved consent form
* Patients who are found intraoperatively to require a specific treatment and are unable to be randomized.
21 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Institute for Sports, Knees, and Shoulders
Scottsdale, Arizona, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Ortho NorthEast
Fort Wayne, Indiana, United States
Orthopedic Clinic
Shreveport, Louisiana, United States
Towson Orthopaedic Associates
Towson, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Buffalo
Buffalo, New York, United States
Joint Implant Surgeons
New Albany, Ohio, United States
Campbell Clinic Orthopaedics
Germantown, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Bon Secours St. Francis Medical Center
Midlothian, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G110207
Identifier Type: OTHER
Identifier Source: secondary_id
ORTHO.CA.GE1.12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.