Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty

Completed · Not applicable

Conditions studied: Anatomic Total Shoulder Arthroplasty

In brief

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.

Key facts

Study ID
NCT01905241
Run by
The Cleveland Clinic
People needed
20
Starts
2013-07-01
Expected to finish
2013-12-01
Last updated by the study team
2021-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.