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

Recruiting in Palo Alto (17 mi)

Overseen byJoseph P Iannotti, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

To be eligible for inclusion, a primary anatomic total shoulder arthroplasty must be indicated for the patient.

Treatment Details

Interventions

Anatomic Total Shoulder Arthroplasty (Procedure)
Anatomic TSA using IRI Instrumentation (Device)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Anatomic TSA Using IRI InstrumentationExperimental Treatment2 Interventions

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.

Group II: Anatomic TSA using SOC InstrumentationActive Control1 Intervention

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.