Trial Outcomes & Findings for Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments (NCT NCT01801241)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Two weeks post surgery

Results posted on

2021-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Anatomic TSA Using SOC Instrumentation 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. 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 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 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. Anatomic TSA using IRI Instrumentation: 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 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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.
Overall Study STARTED	29	27
Overall Study COMPLETED	21	25
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anatomic TSA Using SOC Instrumentation n=21 Participants 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. 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 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 n=25 Participants 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. Anatomic TSA using IRI Instrumentation: 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 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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	25 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks post surgery

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.

Outcome measures

Outcome measures
Measure	Anatomic TSA Using SOC Instrumentation n=21 Participants 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. 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 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 n=25 Participants 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. Anatomic TSA using IRI Instrumentation: 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 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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.
Difference in Glenoid Component Placement (Inclination and Version) Inclination	4.1 degree Interval 2.7 to 5.5	3.1 degree Interval 2.1 to 4.2
Difference in Glenoid Component Placement (Inclination and Version) Version	4.3 degree Interval 3.1 to 5.5	4.0 degree Interval 3.0 to 5.1

PRIMARY outcome

Timeframe: Two weeks post surgery

The overall difference in component placement between standard of care instrumentation and intelligent reusable instrumentation will be compared (Anteroposterior position and Superoinferior position).

Outcome measures

Outcome measures
Measure	Anatomic TSA Using SOC Instrumentation n=21 Participants 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. 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 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 n=25 Participants 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. Anatomic TSA using IRI Instrumentation: 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 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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.
Difference in Glenoid Component Placement (AP and SP). Anteroposterior position	1.7 mm Interval 1.2 to 2.2	1.1 mm Interval 0.8 to 1.5
Difference in Glenoid Component Placement (AP and SP). Superoinferior position	1.5 mm Interval 0.9 to 2.2	0.9 mm Interval 0.5 to 1.3

SECONDARY outcome

Timeframe: Two weeks post surgery

Population: Outcome measures data not collected/ no patients analyzed for this OM. A broader study including different surgeons is required to test the effectiveness of this technology.

Investigators will compare the placement of the glenoid component between the two technologies within and between the two surgeons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two weeks post surgery

Population: The Walch classification of glenoid morphology is the most commonly used system describing glenohumeral pathology in primary osteoarthritis. Glenoids were classified as asymmetric moderate-to severe posterior glenoid bone loss (Walch type-C or moderate to-severe type-B2 and B3 glenoids), without bone loss (Walch type-A1 glenoid), posterior bone loss requiring \<10 degrees of correction (Walch type-B1 or mild type-B2 and B3 glenoids), or symmetric glenoid bone loss (Walch type-A2 glenoid).

Investigators will evaluate the difference in glenoid component position between SOC and IRI technologies based on severity of shoulder pathology (using Walch classifications), if the difference between the severity of shoulder pathology is less than p-value 0.05. If p-value is greater than 0.05, investigators will not evaluate the difference in the glenoid component position between SOC and IRI.

Outcome measures

Outcome measures
Measure	Anatomic TSA Using SOC Instrumentation n=21 Participants 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. 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 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 n=25 Participants 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. Anatomic TSA using IRI Instrumentation: 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 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 in the two arms, with the exception of the tools used to place the guide pin for placement of the glenoid implant.
Effect of Severity of Shoulder Pathology B1	2 Participants	2 Participants
Effect of Severity of Shoulder Pathology B2	6 Participants	12 Participants
Effect of Severity of Shoulder Pathology A1	4 Participants	3 Participants
Effect of Severity of Shoulder Pathology A2	7 Participants	5 Participants
Effect of Severity of Shoulder Pathology C	2 Participants	3 Participants

Adverse Events

Anatomic TSA Using SOC Instrumentation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anatomic TSA Using IRI Instrumentation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph P. Iannotti, MD, PhD

Cleveland Clinic Foundation

Phone: 216-287-1149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place