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NCT01936259 · ClinicalTrials.gov registry record · NA
Comprehensive Shoulder System Nano IDE
A NA study of Joint Disease, sponsored by Zimmer Biomet.
- Completed
- Registry status
- NA
- Development phase
- 258
- Enrollment target
- 12
- Study locations
NCT01936259: Completed NA study of Joint Disease, sponsored by Zimmer Biomet.
NCT01936259 is a NA study of Joint Disease that has completed, run by Zimmer Biomet. The registered enrollment target is 258 participants, above the 108-participant average among 4 other Joint Disease trials with a reported enrollment target (139% higher). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01936259, a NA study of Joint Disease, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- NA
- Development phase
- 258 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
Primary Outcome
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Conditions Studied
Interventions
- DEVICE Mini Stem
- DEVICE Nano
Study Locations (12)
Virginia
- University of Virginia - Charlottesville
- Bon Secours St. Francis Medical Center - Midlothian
Arizona
- Arizona Institute for Sports, Knees, and Shoulders - Scottsdale
Florida
- Holy Cross Hospital - Fort Lauderdale
Indiana
- Ortho NorthEast - Fort Wayne
Louisiana
- Orthopedic Clinic - Shreveport
Maryland
- Towson Orthopaedic Associates - Towson
Michigan
- William Beaumont Hospital - Royal Oak
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2013-08 |
| Est. Completion | 2019-09-27 |
| Phase | NA |
What the finished NCT01936259 record still lists
NCT01936259 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 4 other Joint Disease trials with a reported enrollment target (139% higher).
The record links to 1 condition, with Joint Disease appearing as the primary indexed condition, and to 2 interventions - of which Mini Stem is the first listed.
NCT01936259 lists 12 locations in 11 states (Virginia, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT01936259 about?
NCT01936259 is a clinical study titled "Comprehensive Shoulder System Nano IDE". The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
What is the current status of trial NCT01936259?
This trial is currently completed. It is a NA study. The enrollment target is 258 participants. The study started on 2013-08. Estimated completion is 2019-09-27.
What conditions does trial NCT01936259 study?
This clinical trial studies the following conditions: Joint Disease.
What interventions are being tested in trial NCT01936259?
The interventions under investigation include: Mini Stem (DEVICE), Nano (DEVICE).
Who is sponsoring clinical trial NCT01936259?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01936259 being conducted?
This trial has 12 study locations across Arizona, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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