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

NCT01905241 | Completed Results FDA Device

• 1 other identifier: 13-652
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anatomic total shoulder arthroplasty; Glenoid; Patient specific information; Computer simulation; Computer assisted tomography

Outcome Measures

Primary Outcomes (2)

• Difference in Glenoid Component Placement (Inclination and Version)

  The overall difference in component placement between Real Time Instrumentation, IRI (historical data) and standard of care instrumentation (historical data) and will be compared ((Inclination and Version).

  Two weeks post surgery

• Difference in Glenoid Component Placement (AP and SP)

  The overall difference in component placement between Real Time Instrumentation, IRI (historical data) and standard of care instrumentation (historical data) and will be compared (Anteroposterior Position and Superoinferior Position).

  Two weeks post surgery

Secondary Outcomes (2)

• Difference in Glenoid Component Position Within and Between Surgeons

  Two weeks post surgery

• Effect of Severity of Shoulder Pathology

  Two weeks post surgery

Study Arms (1)

Anatomic TSA using RTI

EXPERIMENTAL

During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.

Device: Anatomic TSA using RTI; Procedure: Anatomic Total Shoulder Arthroplasty

Interventions

Anatomic TSA using RTI DEVICE

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.

Anatomic TSA using RTI

Anatomic Total Shoulder Arthroplasty PROCEDURE

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.

Anatomic TSA using RTI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age less than 18.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Orthopaedic and Rheumatologic Institute

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Hendel MD, Bryan JA, Barsoum WK, Rodriguez EJ, Brems JJ, Evans PJ, Iannotti JP. Comparison of patient-specific instruments with standard surgical instruments in determining glenoid component position: a randomized prospective clinical trial. J Bone Joint Surg Am. 2012 Dec 5;94(23):2167-75. doi: 10.2106/JBJS.K.01209.

  PMID: 23224387 BACKGROUND

Results Point of Contact

• Title: Joseph P. Iannotti, MD, PhD
• Organization: Cleveland Clinic Foundation

IANNOTJ@ccf.org

216-287-1149

Study Officials

• Joseph P Iannotti, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Eric T Ricchetti, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Staff, Executive Administration Florida

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 18, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)