Trial Outcomes & Findings for Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty (NCT NCT01905241)

Results Overview

The overall difference in component placement between Real Time Instrumentation, IRI (historical data) and standard of care instrumentation (historical data) and will be compared ((Inclination and Version).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Two weeks post surgery

Results posted on

2021-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Anatomic TSA Using RTI During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy. Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative 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 with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anatomic TSA Using RTI n=20 Participants During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy. Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative 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 with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.
Age, Customized >=18 years	20 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks post surgery

The overall difference in component placement between Real Time Instrumentation, IRI (historical data) and standard of care instrumentation (historical data) and will be compared ((Inclination and Version).

Outcome measures

Outcome measures
Measure	Anatomic TSA Using RTI n=20 Participants During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy. Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative 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 with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.
Difference in Glenoid Component Placement (Inclination and Version) Inclination	2.0 degrees Standard Deviation 1.7
Difference in Glenoid Component Placement (Inclination and Version) Version	5.3 degrees Standard Deviation 3.7

PRIMARY outcome

Timeframe: Two weeks post surgery

The overall difference in component placement between Real Time Instrumentation, IRI (historical data) and standard of care instrumentation (historical data) and will be compared (Anteroposterior Position and Superoinferior Position).

Outcome measures

Outcome measures
Measure	Anatomic TSA Using RTI n=20 Participants During Anatomic Total Shoulder Arthroplasty (TSA), the surgeon will have use of the SmartBone and the bone cement mold made from the SmartBone (the RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy. Anatomic TSA using RTI: Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative 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 with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.
Difference in Glenoid Component Placement (AP and SP) Anteroposterior Position	1.4 mm Standard Deviation 0.9
Difference in Glenoid Component Placement (AP and SP) Superoinferior Position	1.1 mm Standard Deviation 1.0

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 RTI, IRI and standard of care technologies within and between the two surgeons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two weeks post surgery

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

Investigators will evaluate the difference in glenoid component position between RTI, IRI (historical data) and standard of care (historical data) technologies based on severity of shoulder pathology.

Outcome measures

Outcome data not reported

Adverse Events

Anatomic TSA Using RTI

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