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NCT01905241 · ClinicalTrials.gov registry record · NA
Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01905241 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 20 participants.
The verdict
NCT01905241, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Glenoid component loosening is the most common complication of total shoulder arthroplasty. Loosening is associated with malposition of the implant as well as the quality of the glenoid bone. Past studies from our research group have addressed these problems by investigating novel surgical technologies to increase the accuracy of glenoid implant placement. Over the course of multiple IRB approved clinical trials, use of our preoperative planning software in combination with patient specific instrumentation (PSI) or intelligent reusable instrumentation (IRI) has proven to more accurately place the glenoid guide pin than conventional standard of care techniques. Continuing the investigator's work, the investigators propose a clinical case series to evaluate a new surgical instrumentation technique that combines the features of PSI with the IRI technology that investigators have termed Real Time Instrumentation (RTI). Investigators will measure implant placement with RSA and 3D CT imaging. Investigators will measure pre-operative bone quality using quantitative CT to measure trabecular bone volume and correlate these findings with bone samples removed from the glenoid and measured by microCT and mechanical testing of the bone samples. These bone samples will be obtained as part of the routine preparation of the glenoid bone for implant placement. This bone tissue is normally removed and discarded as part of the standard of care for preparation of the bone for placement of the glenoid. Investigators have performed all of the work required to define both the safety of all components of the proposed study in the completed PSI study and the ongoing IRI study. Since application to the IRB for study of the IRI technology Custom Orthopaedic Solutions has received in April 2013 FDA approval for this technology.
Interventions
- PROCEDURE Anatomic Total Shoulder Arthroplasty
- DEVICE Anatomic TSA using RTI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01905241
The ClinicalTrials.gov registry entry for NCT01905241 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anatomic Total Shoulder Arthroplasty is the first listed.
NCT01905241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01905241 about?
NCT01905241 is a clinical study titled "Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty". Glenoid component loosening is the most common complication of total shoulder arthroplasty. Loosening is associated with malposition of the implant as well as the quality of the glenoid bone. Past studies from our research group have addressed these problems by investigating novel surgical technolog...
What is the current status of trial NCT01905241?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01905241?
The interventions under investigation include: Anatomic Total Shoulder Arthroplasty (PROCEDURE), Anatomic TSA using RTI (DEVICE).
Who is sponsoring clinical trial NCT01905241?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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