Patient Specific Instruments Versus Standard Surgical Instruments (TIOSO - GPS)
|ClinicalTrials.gov Identifier: NCT01430468|
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Total Shoulder Arthroplasty||Procedure: Glenoid Positioning System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
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.
- Comparing Glenoid Component Positioning to Pre Operative Planning [ Time Frame: 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 millimeters and degrees.
- Intra-operative Photographs [ Time Frame: Post Op CT within 1 year from surgery ]We will use the intra-operative photographs to qualitatively document the surgical steps. These photos may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430468
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Joseph P. Iannotti, MD, PhD||The Cleveland Clinic|