Comparison of Glenoid Position Using SmartBones

NCT03035318 | Completed Results FDA Device

• 1 other identifier: 14-789
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid implant placement comparing four groups of patients. Group 1 consists of 3D imaging and computer-generated surgical planning using standard DePuy instrumentation for placement of the glenoid implant. This group is considered the standard of care. Group 2 consists of 3D imaging and computer-generated surgical planning, with use of a SmartBone to trial the standard DePuy instrumentation. (Group 2 is Group 1 with addition of the use of a SmartBone.) Group 3 consists of 3D imaging and computer-generated surgical planning, with use of the IRI technology including a SmartBone, but with metal legs instead of plastic legs in the IRB#13-652 study. Group 4 consists of 3D imaging and computer-generated surgical planning, with use of the RTI technology including a SmartBone. We will measure implant placement based on 3D CT imaging. We will measure pre-operative bone quality using quantitative CT scan to measure trabecular bone volume and correlate these findings with bone samples removed from the humeral head 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 humeral head 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 humeral stem. By comparing a computer generated pre-operative plan to the post-operative glenoid component placement, we will be looking at three outcomes. First, we will determine the overall difference in glenoid component placement between the four treatment groups. Second, we will compare the placement between the technologies within and among surgeons. Third, we will evaluate the difference in implant position between technologies based on severity of pathology. The quality of the humeral head sample will be correlated to the possible loosening of the implants.

Conditions

Anatomic Total Shoulder Arthroplasty

Keywords

Anatomic Total Shoulder Arthroplasty; Glenoid; Patient-specific instrumentation; Computer simulation; Computer assisted tomography

Outcome Measures

Primary Outcomes (2)

• Difference in Glenoid Component Position (Inclination and Version)

  The overall distance between glenoid component placement between Standard Manufacturer Instrumentation and Patient Specific Instrumentation will be compared (Inclination and Version).

  Four months post surgery

• Difference in Glenoid Component Position (AP and IP)

  The overall distance between glenoid component placement between Standard Manufacturer Instrumentation and Patient Specific Instrumentation will be compared (Anteroposterior Position and Superoinferior Position).

  Four months post surgery

Secondary Outcomes (1)

• Accuracy of Glenoid Component Placement Based on Severity of Glenoid Morphology

  Four months post surgery

Study Arms (5)

DePuy Global® Anchor Peg Glenoid

ACTIVE COMPARATOR

In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component.

Device: DePuy Global® Anchor Peg Glenoid Instrumentation

DePuy Instrumentation with SmartBone™

EXPERIMENTAL

In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component.

Device: DePuy Global® Anchor Peg Instrumentation with SmartBone™

IRI with SmartBone™

EXPERIMENTAL

In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component.

Device: IRI with SmartBone™

RTI with SmartBone™

EXPERIMENTAL

In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component.

Device: RTI with SmartBone™

IRI with SmartBase

EXPERIMENTAL

In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component.

Device: IRI with SmartBase

Interventions

DePuy Global® Anchor Peg Glenoid Instrumentation DEVICE

Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.

DePuy Global® Anchor Peg Glenoid

DePuy Global® Anchor Peg Instrumentation with SmartBone™ DEVICE

Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.

DePuy Instrumentation with SmartBone™

IRI with SmartBone™ DEVICE

Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.

IRI with SmartBone™

RTI with SmartBone™ DEVICE

Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.

RTI with SmartBone™

IRI with SmartBase DEVICE

Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.

IRI with SmartBase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of glenohumeral osteoarthritis
• Anatomic Total Shoulder Arthroplasty

You may not qualify if:

• Age \< 18 or \> 80

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Orthopaedic and Rheumatologic Institute

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 30, 2017
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• 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)