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

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.

Conditions

• Anatomic Total Shoulder Arthroplasty

Interventions

DEVICE

Anatomic TSA using RTI

Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.

PROCEDURE

Anatomic Total Shoulder Arthroplasty

Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.

Sponsors & Collaborators

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Joseph P Iannotti, MD PhD · The Cleveland Clinic

• Eric T Ricchetti, MD · The Cleveland Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2013-12-31

Completion

2013-12-31

FDA Device

Yes

Countries

• United States

Study Locations