TIOSO-GPS: Patient Specific Instruments Versus Standard Surgical Instruments

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01430468
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial

Condition or Disease	Intervention/Treatment	Phase
Total Shoulder Arthroplasty	Procedure: Glenoid Positioning System	N/A

Detailed Description

This is a non blinded prospective randomized clinical trial to define the efficacy of a new technology developed at the Cleveland Clinic to improve the positioning of the glenoid component in total shoulder arthroplasty. The Cleveland Clinic research team has worked on the development and validation of this new technology for the last six years. The investigators have validated the pre-operative planning software and published the results in the peer review literature (1, 7, 8, 9). The investigators have used this software in the planning of total shoulder surgery over the last three years. The investigators have validated the accuracy and reproducibility of the patient-specific instrumentation in both cadaver shoulders and Sawbones models of the shoulder using multiple surgeons. These studies also validated our ability to precisely measure component position using 3D CT scan imaging after placement of the implants in a pre-clinical cadaver study, thereby validating our ability to accurately measure and compare component position between the groups described in this proposed clinical trial. The investigators have also proven the ability of the software and techniques to produce an accurate representation of the glenoid morphology in patients with osteoarthritis or rotator cuff deficient arthritis in 13 patients. This was an IRB approved patient safety study performed at the Cleveland Clinic. The investigators have performed extensive studies of the materials and processes for the fabrication, sterilization and packaging of the patient specific instruments. The investigators have selected materials and processes that have met all of the FDA requirements for use of these materials and processes as clinical devices in vivo. These devices (non implanted instruments) are generally classified by FDA as a Class I device not having significant clinical risk. The investigators have studied the materials and process to produce accurate instruments that meet the clinical specification for fit onto the surrogate glenoid surfaces and maintain this shape and fit after sterilization. These same patient specific instruments have been tested in pre-clinical trials (Sawbones and Cadavers), demonstrating their ability to perform the functions specified with a high level of accuracy and much better than the use of standard generic instruments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: 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
No Intervention: Standard Group Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.

Outcome Measures

Primary Outcome Measures

1. Comparing Glenoid Component Positioning to Pre Operative Planning [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.

Secondary Outcome Measures

1. Intra-operative Photographs [Intra-operative]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients otherwise indicated for primary reverse or anatomic total shoulder replacement that are able to get a pre-operative CT scan at the Cleveland Clinic will be considered eligible for enrollment. All patients will be consented in the office as part of the pre-operative consent for surgery and all will need to randomization at the time of surgery

Exclusion Criteria:

• Patients will be excluded if they have significant metal in the joint that results in metal artifact on the CT scan, thereby compromising the ability to visualize the glenoid on the pre-operative simulator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Joseph P. Iannotti, MD, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• Codsi MJ, Bennetts C, Gordiev K, Boeck DM, Kwon Y, Brems J, Powell K, Iannotti JP. Normal glenoid vault anatomy and validation of a novel glenoid implant shape. J Shoulder Elbow Surg. 2008 May-Jun;17(3):471-8. doi: 10.1016/j.jse.2007.08.010. Epub 2008 Mar 7.
• Franta AK, Lenters TR, Mounce D, Neradilek B, Matsen FA 3rd. The complex characteristics of 282 unsatisfactory shoulder arthroplasties. J Shoulder Elbow Surg. 2007 Sep-Oct;16(5):555-62. Epub 2007 May 16.
• Gutiérrez S, Comiskey CA 4th, Luo ZP, Pupello DR, Frankle MA. Range of impingement-free abduction and adduction deficit after reverse shoulder arthroplasty. Hierarchy of surgical and implant-design-related factors. J Bone Joint Surg Am. 2008 Dec;90(12):2606-15. doi: 10.2106/JBJS.H.00012.
• Hafez MA, Chelule KL, Seedhom BB, Sherman KP. Computer-assisted total knee arthroplasty using patient-specific templating. Clin Orthop Relat Res. 2006 Mar;444:184-92.
• Iannotti JP, Spencer EE, Winter U, Deffenbaugh D, Williams G. Prosthetic positioning in total shoulder arthroplasty. J Shoulder Elbow Surg. 2005 Jan-Feb;14(1 Suppl S):111S-121S.
• Matsen FA 3rd, Clinton J, Lynch J, Bertelsen A, Richardson ML. Glenoid component failure in total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Apr;90(4):885-96. doi: 10.2106/JBJS.G.01263.
• Scalise JJ, Bryan J, Polster J, Brems JJ, Iannotti JP. Quantitative analysis of glenoid bone loss in osteoarthritis using three-dimensional computed tomography scans. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):328-35. doi: 10.1016/j.jse.2007.07.013. Epub 2008 Jan 22.
• Scalise JJ, Codsi MJ, Bryan J, Brems JJ, Iannotti JP. The influence of three-dimensional computed tomography images of the shoulder in preoperative planning for total shoulder arthroplasty. J Bone Joint Surg Am. 2008 Nov;90(11):2438-45. doi: 10.2106/JBJS.G.01341.
• Scalise JJ, Codsi MJ, Bryan J, Iannotti JP. The three-dimensional glenoid vault model can estimate normal glenoid version in osteoarthritis. J Shoulder Elbow Surg. 2008 May-Jun;17(3):487-91. doi: 10.1016/j.jse.2007.09.006. Epub 2008 Feb 20.

• Responsible Party: Joseph Iannotti, Institute Chairman, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01430468
• Other Study ID Numbers: CCF 10-582; TECH 09-073
• First Posted: Sep 8, 2011
• Last Update Posted: Jun 1, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Joseph Iannotti, Institute Chairman, The Cleveland Clinic: Glenoid component position; patient specific instruments

Study Results

Participant Flow

Arm/Group Title	Glenoid Positioning System	Standard Group
Arm/Group Description	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	Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Period Title: Overall Study
STARTED	22	22
COMPLETED	15	16
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	Glenoid Positioning System	Standard Group	Total
Arm/Group Description	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	Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.	Total of all reporting groups
Overall Participants	15	16	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.1 (6.8)	67.3 (9.5)	68.2 (8.2)
Sex: Female, Male (Count of Participants)
Female	8 53.3%	11 68.8%	19 61.3%
Male	7 46.7%	5 31.3%	12 38.7%
Region of Enrollment (participants) [Number]
United States	15 100%	16 100%	31 100%
Pre-operative retroversion (Degrees) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Degrees]	-14.8 (10.1)	-11.3 (13.3)	-13.0 (11.8)

Outcome Measures

1. Primary Outcome

Title	Comparing Glenoid Component Positioning to Pre Operative Planning
Description	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.
Time Frame	1 month post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Glenoid Positioning System	Standard Group
Arm/Group Description	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	Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Measure Participants	15	16
Mean (Standard Deviation) [Degrees]	4.3 (4.5)	6.9 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Glenoid Positioning System, Standard Group
	Comments	The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p < 0.05.
	Type of Statistical Test	Equivalence
	Comments	With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.
Statistical Test of Hypothesis	p-Value	0.11
	Comments	P-value was calculated. Threshold for statistical significance (p<0.05)
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Intra-operative Photographs
Description	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.
Time Frame	Intra-operative

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Glenoid Positioning System	Standard Group
Arm/Group Description	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	Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
Measure Participants	15	16
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Glenoid Positioning System		Standard Group
Arm/Group Description	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		Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
All Cause Mortality
	Glenoid Positioning System		Standard Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)
Serious Adverse Events
	Glenoid Positioning System		Standard Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Glenoid Positioning System		Standard Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.