Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments

NCT01801241 | Completed Results FDA Device

• 1 other identifier: IPP-12-245
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative care that is standard of care and specific to the surgeon and patients decisions for care. The only difference between the study groups will be the type of surgical instruments used to place the glenoid guide pin. In all cases the surgeon is able and allowed to use their own surgical judgment to place the guide pin, prepare the bone and place the desired implant. In cases that are randomized to the IRIS group the surgeon can use any and all of the standard instruments or guides provided by the implant manufacturer as the surgeon would use in the group of patients randomized to the standard surgical group. If the surgeon chooses not to use the IRIS instruments then this would be noted as a deviation in plan, the reasons recorded and the patient would be excluded from the study without post operative imaging and there pre - operative and intra - operative data would be analyzed for the purpose of understanding the reasons for failure of the IRIS technology to provide surgical assistance for guide pin placement. For patients included in the post operative data analysis will a study specific shoulder CT scan prior to discharge from the hospital to assess the position of the implant. Deviation in the location and position of the implant as compared plan will be our primary outcome measure. Investigators will compare difference between technologies, differences within and between surgeons and the influence of the severity of the pre operative pathology on the two methods of surgical care.

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 standard of care instrumentation and intelligent reusable instrumentation will be compared (Inclination and Version). Inclination: the angle measurement of the position of the glenoid surface or glenoid implant in the superior-inferior direction. Version: the angle measurement of the position of the glenoid surface or glenoid implant in the anterior-posterior direction.

  Two weeks post surgery

• Difference in Glenoid Component Placement (AP and SP).

  The overall difference in component placement between standard of care instrumentation and intelligent reusable instrumentation 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 (2)

Anatomic TSA using SOC Instrumentation

ACTIVE COMPARATOR

During Anatomic Total Shoulder Arthroplasty, the surgeon will use the pre operative CT scan at least two weeks prior to surgery to define the glenoid pathology, select the implant of choice and plan the placement of that implant in the desired position. This information will be available to the surgeon at the time of surgery but the SmartBone models and the IRI will not be available. The surgeon will have pre operative x-rays and the pre operative CT scan provided by the radiology department for intra - use. The surgeon will perform the surgery using any of the instruments provided for guide pin placement operative the. These include a wide variety of free hand and adjustable guides that assist the surgeon for placement of the guide pin for location and trajectory.

Procedure: Anatomic Total Shoulder Arthroplasty

Anatomic TSA Using IRI Instrumentation

EXPERIMENTAL

During Anatomic Total Shoulder Arthroplasty, the surgeon will have use of the SmartBone model of the patient's anatomy and glenoid guide-pin location, and the Intelligent Reuseable Instrument for placement of the glenoid implant.

Device: Anatomic TSA using IRI Instrumentation; Procedure: Anatomic Total Shoulder Arthroplasty

Interventions

Anatomic TSA using IRI Instrumentation DEVICE

Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Intelligent Reusable Instrument (IRI) to transfer the pre-operative plan for glenoid implant positioning to the patient's anatomy.

Anatomic TSA Using IRI Instrumentation

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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.

Anatomic TSA Using IRI Instrumentation; Anatomic TSA using SOC Instrumentation

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 (2)

• 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

• Iannotti JP, Weiner S, Rodriguez E, Subhas N, Patterson TE, Jun BJ, Ricchetti ET. Three-dimensional imaging and templating improve glenoid implant positioning. J Bone Joint Surg Am. 2015 Apr 15;97(8):651-8. doi: 10.2106/JBJS.N.00493.

  PMID: 25878309 DERIVED

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: Cheif of Staff, Executive Administration Florida

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)