Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
Phase: NA
Conditions: Anatomic Total Shoulder Arthroplasty
Sponsor: The Cleveland Clinic

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Comparison of Glenoid Component Position Using 
Intelligent Reusable Instrument vs. Standard Surgical 
Instruments  
 
NCT01801241  
 
12/04/2013 

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Comparison of Glenoid Component Position Using Intelligent Reusable Instrument vs. Standard 
Surgical Instruments – 12-997 
 
Principle Investigator 
Joseph P. Iannotti MD, PhD 
Co Investigators 
Eric Ricchetti MD 
Scott Weiner DO 
Study coordinator 
Michelle Hines 
 
 
Summary Work and Proposed Study: 
 
Overall Summary 
Glenoid component loosening is the most common complication of total shoulder arthroplasty. 
Loosening is associated with malposition of the implant as well as to the quality of the glenoid 
bone. In order to evaluate glenoid component loosening, the motion of the glenoid implant 
relative to the scapula post-operatively must be accurately measured.  We will study the effect of 
a novel method of surgical planning and surgical technique on position of the implant and the 
quality of the bone on early implant movement.  We propose a randomized clinical trial to 
compare two methods of surgical instrumentation. We will measure implant placement with 
RSA and 3D CT imaging. We will measure pre operative bone quality using quantitative CT 
Scan to measure trabecular bone volume and correlate these finding with bone samples removed 
from the humeral head and measured by microCT and mechanical testing of the bone samples. 
This bone tissue is normally removed and discarded as part of the standard of care for 
preparation of the bone for placement of the humeral component.   
 
Glenoid Instrumentation and Pre operative planning 
Currently, implantation of total shoulder arthroplasty components relies on a combination of pre-
surgical planning using routine radiographs and CT scanning along with the use of generic 
surgical instruments provided by the implant manufacture and surgical experience. New 
developments at the Cleveland Clinic has allowed our surgeons to use pre operative planning 
software for simulation of the surgical plan to select the optimal implant from an inventory of 
FDA approved and commercial available implants and the optimal location of that implant 
within the bone.  However, there remains a void in transferring the pre-surgical planning 
information from the computer simulation to the surgical site.  Development at the Cleveland 
Clinic of an intelligent reusable instrument system (IRIS) in conjuncture with smart bone 
surrogate models (SmartBones) have demonstrated the ability to transfer the information from 
the software to the surgical site. The proof of this concept has been demonstrated in pre clinical 
plastic sawbone models and cadavers that simulate the surgical environment. An FDA 
application for approval of this technology for commercial use was submitted in early October of 
this year.  
 
We are proposing the first in man use of this technology for placement of the glenoid component 
in anatomic total shoulder arthroplasty. We will use post operative 3D CT Scanning to precisely 

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define the location of the implant as compared to plan. We propose to compare the accuracy of 
implant placement using the IRIS and SmartBone technology when compared to the use of the 
same pre operative planning software for selection of the desired implant and its optimal location 
with standard of care surgical instrumentation. This will be a randomized clinical trial and in all 
cases the surgeon will have full control to define the optimal implant and its location as well as 
have full control of the placement of the guide wire, bone preparation and location and 
placement of the final implant. In this regard the new technology assists the surgeon in pre 
operative planning and surgical execution it does not substitute for the surgeon performing the 
planning or surgery in a manner that it believed to be best for the patient. 
 
Using the intelligent reusable instrument (IRIS) and SmartBone system in a pre-clinical 
sawbones trial, we demonstrated a statistically and clinically significant improvement in the 
accuracy of glenoid pin placement.  Three surgeons were asked to place a guide pin in nine 
different pathologic models utilizing three separate surgical techniques. The sawbone models 
were covered to show only that part of the scapula that is seen at the time of surgery. Standard of 
care (n=59 cases), standard of care with pre-surgical CT (n=59 cases) information and the use of 
IRIS and SmartBone system (n=89 cases) were performed to assess deviation from the pre-
surgical plan.   
 
Measurement of Implant Position 
 
Post operatively we will obtain a CT scan with metal artifact reduction technology within the 
first few weeks after surgery and will generally obtain this scan prior to discharge from the 
hospital. A second CT scan will be obtained at two years after surgery. We have used these 
methods of 3D CT imaging to determine implant position in several prior studies.  We have 
defined the accuracy of these measurements using first generation techniques to be within 1 
millimeter and 3 degrees. 
 
RSA imaging will be obtained at these same points in time. RSA imaging uses biplanar 
fluoroscopic imaging within a calibration grid and image software to define implant position. 
This technology has been a standard for precise implant position for the last 20 years and has 
been used in thousands of patients. RSA imaging uses metallic markers placed in the implant and 
in the surrounding bones. The beads implanted in the bone and implant, do not move, and are 
then used as markers to define the location of the implant to the bone and the bones to one 
another. The accuracy of RSA measurement has been reported to be +/- 0.006mm in translation 
and 0.5 degrees in rotation. For RSA measurements a minimum of three 1mm radiopaque 
tantalum beads into an implant and at least three beads into the surrounding bone when using the 
RSA system.  
 
Placement of three beads into the implant will also improve the ability of the post operative 3D 
CT imaging to define the location of the implant and will be an improvement over our first 
generation technology. A metal wire is placed in the center peg of the implant by the 
identification of the implant.  
 

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The risk of the bead becoming loose has been shown to be very small and there is no adverse 
effects related to bead movement or loosening. Both study groups will receive glenoid 
components with three 1mm tantalum beads inserted into the back pegs.  
 
RSA and 3D CT measurements will be correlated and compared. Our goal is to define the 
accuracy of second generation 3D CT scanning when compared to a gold standard of RSA 
measurements.  
 
Bone Quality Measurements 
To assess bone quality and its effect on glenoid component loosening, we will take trabecular 
bone samples from both the experimental and standard of care groups. Humeral heads, which are 
normally discarded as standard of care medical waste will be kept and evaluated with mechanical 
testing. These bone samples will be assessed by microCT to measure trabecular bone volume and 
connectivity as well as by mechanical testing.  This data will be correlated with the trabecular 
bone volume of the glenoid defined by the pre operative CT scans. In addition all bone quality 
measurements will be correlated with CT scan imaging of the glenoid at the time of surgery and 
at two year follow up.   
 
Patient Enrollment 
The proposed clinical study will enroll patients indicated for standard of care anatomic total 
shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including 
all implants and post operative care that is standard of care and specific to the surgeon and 
patients decisions for care.   The only difference between the study groups will be type of 
surgical instruments used to place the glenoid guide pin. In all cases the surgeon is able and 
allowed to use their own surgical judgment to place the guide pin, prepare the bone and place the 
desired implant. In cases that are randomized to the IRIS group the surgeon can use any and all 
of the standard instruments or guides provided by the implant manufacturer as the surgeon would 
use in the group of patients randomized to the standard surgical group. If the surgeon chooses not 
to use the IRIS instruments then this would be noted as a deviation in plan, the reasons recorded 
and the patient would be excluded from the study without post operative imaging and there pre – 
operative and intra – operative data would be analyzed for the purpose of understanding the 
reasons for failure of the IRIS technology to provide surgical assistance for guide pin placement.     
 
Detailed Study Design: 
The study will enroll 60 patients, 30 standard surgery group and 30 in the IRI surgical group, 
into a randomized clinical trial. We will have two surgeons with experience in shoulder 
arthroplasty and the IRIS and SmartBones technology. We will require a minimum of ten 
patients in each surgical group (n=20) from any one surgeon. Enrollment by any one surgeon 
will be limited so that all surgeons achieve a minimum of 20 cases enrolled.  All patients will 
have the standard of care indications for an anatomic total shoulder arthroplasty and will give 
informed consent for both the surgery and participation in this study. Consent and enrollment 
will be obtained by the surgeon during a routine office evaluation. All patients will get standard 
of care pre operative x-rays and CT scan at least three weeks prior to surgery. Scan quality must 
meet study specific criteria and we expect that the scans will be performed at the Cleveland 
Clinic.  The pre operative CT scan will be placed within our pre operative planning software 
(OrthoVis Cleveland Clinic). The surgeon will use this software to assess the glenoid bone 

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pathology and select the optimal implant and placement of that implant. After pre operative 
planning each patient will be randomized into either an IRIS group which will use the pre-
operative 3D surgical planning software and the data from this software to create a sterile 
SmartBone model containing the desired location of the glenoid guide pin and instructions for 
use of an intelligent reusable instrument to assist the surgeon in placement of the guide pin 
within the patients glenoid. In the standard treatment group the surgeon will receive the data 
from the pre operative surgical simulation and use the instruments provided by the implant 
manufacturer. Statistician provided randomization envelopes will be provided to sort the patients 
into experiment and standard of care groups 
Patients will have standard of care indications for primary anatomic arthroplasty and be able to 
get a pre-operative shoulder CT scan at the Cleveland Clinic or at an outside facility so long as 
the study includes the entire scapula and has 1mm or thinner sections. These parameters are 
required for accurate pre operative planning as well as comparison with the post operative CT 
scans. Standard of care pre- and post-operative x-rays (AP and axillary views) will also be 
obtained and can be preformed at the Cleveland Clinic or acquired from another health care 
facility. In all patients the standard x-rays and CT images provided by the radiology department 
will be available to the surgeon before and during the surgery.  
For the experimental group, the cannulated IRIS instrument designed for glenoid pin placement 
is placed over the guide wire that is contained within the sterile SmartBone and the legs of the 
instrument are adjusted to record the relationship (location and trajectory) of the guide pin in 
relation to the patient specific glenoid anatomy. This is done at the time of surgery to properly 
mimic the desired pin placement. The location of each leg of the IRI is marked on the SmartBone 
with a surgical pen. The instrument is then removed from the smart bone model. The SmartBone 
model is visually compared by the surgeon to the exposed bone surface to ensure that the two 
match for shape and size. Any adjustments to the surgical site may be done by the surgeon to 
optimize the match between the model and the exposed glenoid surface. The marks placed by the 
surgeon on the model are then transferred to the patient bone using a surgical marker or bovie. 
These marks are in a general location as determined by the surgeon and assist in the placement of 
the IRI. The IRI is placed onto the patient bone surface in the same manner as it was placed on 
the SmartBone model and a guide pin provided by the manufacturer is placed into the desired 
position. The surgeon then removes the IRI and compares by visual inspection the location and 
trajectory of the guide pin in relation to the patients bone surface and that within the SmartBones 
model. Any adjustments in guide pin position can be performed by the surgeon based upon 
surgical judgment. The surgeon can make any change needed and use any means or instrument 
that would otherwise be used for standard of care surgery to place the guide pin in any position 
that the surgeon believed to be best for the patient. If the pin is changed without the use of the 
IRI then the patient will be excluded from this study and the reasons for failure of the IRI 
technology to provide accurate pin placement based upon the surgeons sole determination of 
accuracy will be recorded and later analyzed as a failure to treat. These patients will not receive 
post operative CT Scans as we would not be able to use the data within any one group as defined 
by this study. After placement of the guide pin the remainder of the procedure is completed in 
the same manner for both groups, using the implant manufacturer’s equipment. 
  
In the standard instrument group, the surgeon will use the pre operative CT Scan at least two 
weeks prior to surgery to define the glenoid pathology, select the implant of choice and place 
that implant in the desired position. This information will be available to the surgeon at the time 

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of surgery but the SmartBone models and the IRI will not be available. The surgeon will have the 
pre operative x-rays and the pre operative CT scan provided by the radiology department for 
intra – operative use. The surgeon will perform the surgery using any of the instruments provided 
for guide pin placement. These include a wide variety of free hand and adjustable guides that 
assist the surgeon for placement of the guide pin for location and trajectory. Which tools are used 
for each case will be recorded at the time of surgery.  
 
Prior to implanting the glenoid component, three 1mm tantalum beads will be inserted into the 
backside pegs of the component. We have developed methods to place the beads in a manner that 
has been used by other investigators. The desired implant will be placed into a holding device 
(figure 1) and using a drill guide, a 0.9 mm hole measuring 2 mm deep will be placed in each of 
the three peripheral pegs of the implant (figure 2). A 1 mm tantalum bead (RSA biomedical, 
Umsa Sweden) supplied by the company will then be press fit into the component hole. The 
implant will then be placed in the glenoid, aligned with the previously drilled peg holes. As 
standard of care, these peg holes are cemented, thus locking the beads within the implant.  
 
Using manufacturer (RSA biomedical, Umsa Sweden) provided beads and injector gun (figure 
3), four to five 1mm tantalum beads will be placed in the coracoid, acromion and glenoid.9 Exact 
placement of these beads is at the discretion of the surgeon. Patient anatomy and operative 
exposure will guide the surgeon to the best places to inject the beads; however the surgeon will 
not be confined to a specific amount of beads in a specific location.(figure 4) The beads just need 
to be spread out amongst the coracoid, acromion, and glenoid to establish reference points for the 
RSA imaging. Prior studies looking at should joint kinematics and implant position have used 
this methodology of bead placement with successful study related outcomes.9,10,13  
 
Post operatively, all patients will receive a CT with MAR and RSA (if chosen) within 3 weeks of 
surgery. This will be a CT Scan performed with the patients arm by the side in a supine position 
using metal artifact reduction techniques. In addition patients will receive a second CT scan and 
RSA imaging, provided they originally got RSA, performed 2 years (± 1 month) from surgery. 
The second CT scan will be performed with MAR techniques and with the patient in the lateral 
decubitus position with their arm in the overhead position again using metal artifact reduction 
techniques. The second set of images produce with a different body and arm position also 
decreases metal artifact than those obtained with the arm placed by the side. This position can 
not be comfortably obtained until 3- 6 months after surgery and require healing of the tissues and 
rehabilitation of the shoulder. We have shown that in a small number of patients the glenoid 
component can shift in position within the first 3-6 months after surgery making the first CT 
Scan more accurate for implant position.  The images obtained from the post-operative CT scans 
are placed back into the surgical software and the 3D reconstruction of the post-operative scapula 
with the implants is compared to the pre-operative plan. Using measurement tools within the 
software, developed at the Cleveland Clinic, we will compare the position of the actual glenoid 
component placed in the patient with the desired position specified by the plan. The use and 
validation of these imaging methods to precisely measure implant position has been performed at 
the Cleveland Clinic in a prior IRB approved clinical trial (IRB 10-582). Similarly, the post 
operative CT scans will be compared to find any micromotion of the tantalum beads previously 
placed in the glenoid implant.    

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 Preoperatively, the high resolution quantitative CT will measure volumetric bone mineral 
density and the trabecular network of the glenoid. This will be done at same visit for the standard 
of care pre operative CT. Micro CT imaging, which creates a 3D reconstruction of the fine bone 
structure, in addition to microarchitecture analysis and mechanical testing, will allow assessment 
of the bone tissue taken from the bone core sample.  Between the preoperative imaging and the 
bone tissue analysis, we will have data to properly determine the quality of the bone stock 
surrounding the implant.  Further correlating this with RSA and 3D CT imaging of implant 
movement, we can fully develop cause and effect of bone quality on glenoid component 
loosening. 
 
The participating surgeons will be Dr. Joseph Iannotti and Dr. Eric Ricchetti. Patient may have 
surgery at either Cleveland Clinic main campus or at Euclid Hospital.  If the procedure is 
performed at Euclid Hospital, post operative CT scan and RSA (if chosen), will need to be taken 
at main campus within 3 weeks. The patient will be made aware of this at the time of enrollment 
and consent. 
 
Inclusion/Exclusion Criteria: 
To be eligible for inclusion, a primary anatomic total shoulder arthroplasty must be indicated for 
the patient.  
Outcome Measures: 
By comparing computer generated pre-operative plan to post op component placement, we will 
be looking at three outcomes.  First, the overall difference in component placement between 
standard of care instrumentation and intelligent reusable instrumentation will be compared.  
Secondly, we will compare the placement between the two technologies within and between 
surgeons.  Thirdly, we will evaluate the difference in implant position between technologies 
based on severity of pathology. The quality of the bone core sampled will be correlated to the 
possible loosening of the implants. 
 
Sample Size: 
Using statistical analysis of the previous saw bone study data, a study pool of 26 patients per 
group, 52 patients total, is needed to achieve 80% power.  However to increase the power of the 
study we propose enrolling 60 total patients with 30 patients in each surgical group, IRI vs. 
Standard of Care.   
 
 
Statistical Methods 
Two groups of patients will be compared on the outcome of interest using Student T-test or 
Wilcoxon rank sum test as appropriate. Summary statistics will be presented as Mean +/- SD or 
Median (25th percentile, 75th percentile). 
 
Subgroup analysis by surgeon and severity of disease will also be conducted as above as 
secondary aims. 
 
The significance level for each hypothesis will be 0.05.  SAS software, Carey, NC, will be 
used for all analyses. 

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Data Sheets 
Clinical data collected pre and post operative will be Passive and Active range of motion, manual 
muscle strength testing and shoulder functional scores, and co-morbidities all of which are 
standard of care. Post operative data will be collected at two years (± 1 month) after surgery.  
We will collect at the time of surgery the implant used, the time for surgical care glenoid 
exposure to end of pin placement. The implant used, the surgical instruments used and any 
comments from the surgeon as to the easy of use and accuracy of the IRI instruments or the 
standard instruments. Verbatim comments will be solicited and recorded by a research assistant 
attending all surgical procedures.  
Pre operative imaging data will include: Glenoid version and inclination, estimated pre morbid 
inclination, version and depth of glenoid bone loss using the glenoid vault model. Preferred 
implant type inclination and version.  
Post operative implant placement to desired location will be defined for location of the center 
peg of the implant in the SI, AP and ML dimension in millimeters and the trajectory of the center 
peg actual vs plan in version and inclination. The location of the implant in relation to the joint 
line as measured by the glenoid vault model will be measured in millimeters. Back side contact 
of the implant to the bone will be measured as a surface area in direct contact with the bone and 
any lucent lines around the implant pegs will be measured as defined by Youderian et al. Peg 
perforation and the location of the peg perforation will be recorded.  
Changes in implant position from post operative CT scan 1 vs CT Scan 2 will be correlated with 
back side seating, implant type, medialization of the joint line and peg perforation and severity of 
the post operative pathology. The tantalum beads within each implant will be measured for 
translational or rotational movement. 
Bone biopsy samples will be evaluated based on mechanical properties such as Young’s 
modulus, yield stress/strain, maximum elastic strain energy, ultimate stress/strain, and energy 
absorbed at failure.   
Study data will be collected and managed using REDCap (Research Electronic Data Capture). 
Adverse Events and Data Monitoring Committee (DMC): 
A Data Monitoring Committee will not be used.  Patient safety will be protected by following surgical standards of 
care.  The IRB will be notified in writing of any adverse clinical event related to the use of the IRI or the standard 
instrumentation.  Adverse events include excessive bleeding, infection, fracture nerve injury or need for revision 
surgery during the term of this study which is expected to be approximately two years from the time of surgery.  
 
Consent: 
During a pre-operative office visit the patient’s primary surgeon will conduct the consent interview, obtain the 
signed consent, witness and send the original to the study coordinator. A copy of each consent form will be sent to 
the surgeon for their records. Consent forms may also be sent to patients if they are located out of town.  Research 
personnel will send multiple copies of the informed consent along with a self-addressed stamped envelope to the 
patient home for review, signature and return.  Prior to the patient signing the informed consent, research personnel 
or the surgeon will call the patient to discuss the study, answer questions and ensure that the patient fully 
understands all aspects of the study.  After being contacted, the patient may then sign and send back the informed 
consent. 
 
Funding Sources and Budget 

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Funding source: State of Ohio Biomedical Research and Development Grant to the Cleveland 
Clinic JP Iannotti Principle Investigator.  
 
References: 
1. Verbogt O, DeSmedt T, Vanhees M, Clockaerts S, Parizel PM, and Van Glabbeek F.  Accuracy of placement of 
the glenoid component in reversed shoulder arthroplasty with and without navigation. J Shoulder Elbow Surg 
2011; 20: 21-26. 
2. Nguyen D, Ferreira LM, Brownhill JR, King GJW, Drosdowech DS, Faber KJ, and Johnson J. Improved 
accuracy of computer assisted glenoid imnplantation in total shoulder arthroplasty: an in-vitro randomized 
controlled trial. J Shoulder Elbow Surg 2009;18: 907-14. 
3. Kircher J, Wiedemann M, Magosch P, Lichtenberg S, and Habermeyer P. Improved accuracy of glenoid 
positioning in total shoulder arthroplasty with intraoperative navigation: a prospective randomized clinical 
study.  J Shoulder Elbow Surg 2009;18: 515-20. 
4. 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; 90: 
2438-45. 
5. Matsen FA, Clinton J, Lynch J, Bertelsen A, and Richardson M. Glenoid component failure in Total Shoulder 
Arthroplasty. J Bone Joint Surg Am 2008;90:885-96. 
6. Franta AK, Lenteres TR, Mounce D, Neradilek B, and Matsen FA.  The Complex Characteristics of 282 
Unsatisfactory Shoulder Arthroplasties. J Shoulder Elbow Surg 2007;16:555-562. 
7. Hendel MD, Bryan JA, Barsoum WK, Rodriguez EJ, Brems JJ, Evans PJ, Iannotti JP. Comparison of glenoid 
component position using patient specific instruments vs. standard surgical instruments: A randomized 
prospective clinical trial. J Bone Joint Surg. In Press. 
8. Madanat R, Makinen TJ, Moritz N, Mattila KT, Aro HT. Accuracy and precision of radiostereometirc analysis 
in the measurement of three dimensional micromotion in a fracture model of the distal radius. J Orthop Res. 
2005;23:481-8. 
9. Nuttall, D., J.F. Haines, and Trail, II.  A study of the micromovement of pegged and keeled glenoid components 
compared using radiostereometric analysis. J Shoulder Elbow Surg, 2007. 16(3 Suppl): p. S65-70. 
10. Nuttall, D., J.F. Haines, and I.A. Trail. The early migration of a partially cemented fluted pegged glenoid 
component using radiostereometric analysis. J Shoulder Elbow Surg, 2012. 21(9): p. 1191-6. 
11. Nagels J, Valstar ER, Stokdijk, Rozing PM. Patterns of loosening of the glenoid component. J Bone Joint Surg 
Br, 2002. 84(1): p. 83-7. 
12. Rahme, H., P. Mattsson, and S. Larsson. Stability of cemented all-polyethylene keeled glenoid components. A 
radiostereometric study with a two-year follow-up. J Bone Joint Surg Br, 2004. 86(6): p. 856-60. 
13. Nuttall, D., J.F. Haines, and I.A. Trail. The effect of the offset humeral head on the micromovement of pegged 
glenoid components: a comparative study using radiostereometric analysis. J Bone Joint Surg Br, 2009. 91(6): 
p. 757-61. 
14. Bey MJ, Zauel R, Brock SK, Tashman S. Validation of a new model based tracking technqiue for measuring 
three dimensional, in vivo glenohumeral joint kinematics. J Biomech Eng 2006;128:604-9. 
15. Karantzoulis V, Liapi C, Papaggelopoulos P. Large scale bone mineral histomorphometry- report of a 
simplified technique. Histopathology 2012;6:1174-82. 
16. Ding M, Danielsen CC, Hvid I, Overgaard S. Three-Dimensional microarchitecture of adolescent cancellous 
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Sciences 2006;1068:410-28 
 
 
 
 
 

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Figure 1: Holding block for glenoid component 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2: Holding block and drill guide for tantalum bead insertion into glenoid component 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
Bead Inserter 
Tantalum Bead 
Surgical Drill Bit 
Sliding Drill Guide 

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Figure 3: Tantalum bead injector (RSA Biomedical, Umsa Sweden) 
 
 
 
 
Figure 4: Bead positioning in scapula