Patient Specific Instruments Versus Standard Surgical Instruments (TIOSO - GPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by The Cleveland Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Joseph Iannotti, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01430468
First received: September 1, 2011
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Total Shoulder Arthroplasty
Procedure: Glenoid Positioning System
Phase 1

Study Type: Interventional
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

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 34
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)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430468

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Joseph P. Iannotti, MD, PhD The Cleveland Clinic
  More Information

Additional Information:
Publications:

Responsible Party: Joseph Iannotti, Institute Chairman, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01430468     History of Changes
Other Study ID Numbers: CCF 10-582, TECH 09-073
Study First Received: September 1, 2011
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Glenoid component position
patient specific instruments

ClinicalTrials.gov processed this record on July 28, 2014