Trial Outcomes & Findings for Patient Specific Instruments Versus Standard Surgical Instruments (NCT NCT01430468)

Results Overview

Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in degrees.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

1 month post op

Results posted on

2020-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Glenoid Positioning System For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component	Standard Group Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Overall Study STARTED	22	22
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Glenoid Positioning System For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component	Standard Group Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Overall Study Physician Decision	2	1
Overall Study Withdrawal by Subject	5	5

Baseline Characteristics

Patient Specific Instruments Versus Standard Surgical Instruments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glenoid Positioning System n=15 Participants For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component	Standard Group n=16 Participants Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.	Total n=31 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 6.8 • n=5 Participants	67.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	68.2 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Pre-operative retroversion	-14.8 Degrees STANDARD_DEVIATION 10.1 • n=5 Participants	-11.3 Degrees STANDARD_DEVIATION 13.3 • n=7 Participants	-13.0 Degrees STANDARD_DEVIATION 11.8 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month post op

Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in degrees.

Outcome measures

Outcome measures
Measure	Glenoid Positioning System n=15 Participants For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component	Standard Group n=16 Participants Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Comparing Glenoid Component Positioning to Pre Operative Planning	4.3 Degrees Standard Deviation 4.5	6.9 Degrees Standard Deviation 4.4

SECONDARY outcome

Timeframe: Intra-operative

Population: Number participants with deviation in the surgery than expected by the pre-operative simulator.

Intra-operative photographs will be used to qualitatively, not quantitatively, to document the surgical steps and may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator. No quantitative data will be collected from the photographs.

Outcome measures

Outcome measures
Measure	Glenoid Positioning System n=15 Participants For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments. Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component	Standard Group n=16 Participants Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Intra-operative Photographs	0 Participants	0 Participants

Adverse Events

Glenoid Positioning System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Group

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: 216-445-5151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place