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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Iannotti, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01430468
First received: September 1, 2011
Last updated: January 18, 2017
Last verified: January 2017
Results First Received: January 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Total Shoulder Arthroplasty
Intervention: Procedure: Glenoid Positioning System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Glenoid Positioning System   Standard Group
STARTED   18   18 
COMPLETED   15   16 
NOT COMPLETED   3   2 
Physician Decision                2                1 
Withdrawal by Subject                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Glenoid Positioning System   Standard Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   16   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.1  (6.8)   67.3  (9.5)   68.2  (8.2) 
Sex: Female, Male 
[Units: Participants]
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 
[Units: Participants]
     
United States   15   16   31 
Pre-operative retroversion [1] 
[Units: Degrees]
Mean (Standard Deviation)
 -14.8  (10.1)   -11.3  (13.3)   -13.0  (11.8) 
[1] Degrees of retroversion from 3-D CT scan


  Outcome Measures

1.  Primary:   Comparing Glenoid Component Positioning to Pre Operative Planning   [ Time Frame: 1 month post op ]

2.  Secondary:   Intra-operative Photographs   [ Time Frame: Post Op CT within 1 year from surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joseph P. Iannotti, MD, PhD
Organization: Cleveland Clinic Foundation
phone: 216-445-5151
e-mail: iannotj@ccf.org


Publications:


Responsible Party: Joseph Iannotti, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01430468     History of Changes
Other Study ID Numbers: CCF 10-582
TECH 09-073 ( Other Grant/Funding Number: State of Ohio BRCP research grant )
Study First Received: September 1, 2011
Results First Received: January 18, 2017
Last Updated: January 18, 2017