Patient Specific Instruments Versus Standard Surgical Instruments (TIOSO - GPS)
Recruitment status was Active, not recruiting
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.
Total Shoulder Arthroplasty
Procedure: Glenoid Positioning System
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial|
- Comparing Glenoid component positioning to pre operative planning [ Time Frame: 1 month post op ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430468
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Joseph P. Iannotti, MD, PhD||The Cleveland Clinic|