Trial Outcomes & Findings for Comparison of Glenoid Position Using SmartBones (NCT NCT03035318)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

Four months post surgery

Results posted on

2021-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	DePuy Global® Anchor Peg Glenoid In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component. DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.	DePuy Instrumentation With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component. DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.	IRI With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component. IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.	RTI With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component. RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.	IRI With SmartBase In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component. IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.
Overall Study STARTED	24	25	25	25	27
Overall Study COMPLETED	22	21	21	23	20
Overall Study NOT COMPLETED	2	4	4	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Glenoid Position Using SmartBones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DePuy Global® Anchor Peg Glenoid n=22 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component. DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.	DePuy Instrumentation With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component. DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.	IRI With SmartBone™ n=23 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component. IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.	RTI With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component. RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.	IRI With SmartBase n=20 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component. IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.	Total n=107 Participants Total of all reporting groups
Age, Customized >=18 years	22 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	21 Participants n=4 Participants	20 Participants n=21 Participants	107 Participants n=8 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	12 Participants n=21 Participants	31 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	15 Participants n=4 Participants	8 Participants n=21 Participants	76 Participants n=8 Participants

PRIMARY outcome

Timeframe: Four months post surgery

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

Outcome measures

Outcome measures
Measure	DePuy Global® Anchor Peg Glenoid n=22 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component. DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.	DePuy Instrumentation With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component. DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.	IRI With SmartBone™ n=23 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component. IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.	RTI With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component. RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.	IRI With SmartBase n=20 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component. IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.
Difference in Glenoid Component Position (Inclination and Version) Version	3.9 degrees Standard Deviation 3.4	4.5 degrees Standard Deviation 3.9	4.0 degrees Standard Deviation 2.5	4.3 degrees Standard Deviation 3.3	3.7 degrees Standard Deviation 2.7
Difference in Glenoid Component Position (Inclination and Version) Inclination	3.5 degrees Standard Deviation 3.0	3.0 degrees Standard Deviation 3.2	3.0 degrees Standard Deviation 2.6	2.5 degrees Standard Deviation 1.8	2.5 degrees Standard Deviation 1.8

PRIMARY outcome

Timeframe: Four months post surgery

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

Outcome measures

Outcome measures
Measure	DePuy Global® Anchor Peg Glenoid n=22 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component. DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.	DePuy Instrumentation With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component. DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.	IRI With SmartBone™ n=23 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component. IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.	RTI With SmartBone™ n=21 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component. RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.	IRI With SmartBase n=20 Participants In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component. IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.
Difference in Glenoid Component Position (AP and IP) Anteroposterior Position	1.2 mm Standard Deviation 0.8	1.5 mm Standard Deviation 0.9	1.1 mm Standard Deviation 0.8	1.5 mm Standard Deviation 1.1	1.1 mm Standard Deviation 0.9
Difference in Glenoid Component Position (AP and IP) Superoinferior Position	1.2 mm Standard Deviation 1.1	1.4 mm Standard Deviation 0.9	1.6 mm Standard Deviation 1.0	1.3 mm Standard Deviation 0.9	1.1 mm Standard Deviation 0.9

SECONDARY outcome

Timeframe: Four months post surgery

Population: Outcome measures data not collected/ no patients analyzed for this OM.

Accuracy of glenoid component placement based on severity of glenoid morphology. Each shoulder was classified according to a modified Walch classification. 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).