Comparison of Glenoid Position Using SmartBones
Condition: Anatomic Total Shoulder Arthroplasty
Study type: Interventional

Summary: 
      The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid
      implant placement comparing four groups of patients. Group 1 consists of 3D imaging and
      computer-generated surgical planning using standard DePuy instrumentation for placement of
      the glenoid implant. This group is considered the standard of care. Group 2 consists of 3D
      imaging and computer-generated surgical planning, with use of a SmartBone to trial the
      standard DePuy instrumentation. (Group 2 is Group 1 with addition of the use of a SmartBone.)
      Group 3 consists of 3D imaging and computer-generated surgical planning, with use of the IRI
      technology including a SmartBone, but with metal legs instead of plastic legs in the
      IRB#13-652 study. Group 4 consists of 3D imaging and computer-generated surgical planning,
      with use of the RTI technology including a SmartBone.

      We will measure implant placement based on 3D CT imaging. We will measure pre-operative bone
      quality using quantitative CT scan to measure trabecular bone volume and correlate these
      findings with bone samples removed from the humeral head and measured by microCT and
      mechanical testing of the bone samples. These bone samples will be obtained as part of the
      routine preparation of the humeral head for implant placement. 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 stem.

      By comparing a computer generated pre-operative plan to the post-operative glenoid component
      placement, we will be looking at three outcomes. First, we will determine the overall
      difference in glenoid component placement between the four treatment groups. Second, we will
      compare the placement between the technologies within and among surgeons. Third, we will
      evaluate the difference in implant position between technologies based on severity of
      pathology. The quality of the humeral head sample will be correlated to the possible
      loosening of the implants.
    

Detailed description: 
      The proposed clinical study will enroll patients indicated for standard of care anatomic
      total shoulder arthroplasty. Participants 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's and patient's decisions for care. The only change for Groups 2,
      3 and 4 will be the type of surgical instruments used to place the glenoid guide pin,
      retention of the humeral head to obtain bone tissue, placement of the beads and
      post-operative CT scanning. 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
      all cases, the surgeon can use any and all of the standard instruments or guides provided by
      the implant manufacturer as the surgeon would use if the patient was not enrolled in the
      study. If the surgeon chooses not to use the IRI or RTI technology, 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 their pre-operative and intra-operative data would be
      analyzed for the purpose of understanding the reasons for failure of the IRI or RTI
      technology to provide assistance for refinement of the technology.

      The participating surgeons will be Dr. Joseph Iannotti, Dr. Eric Ricchetti and Dr. Peter
      Evans. Patients 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 be performed at main campus within 3 weeks after surgery. The patient will
      be made aware of this at the time of enrollment and consent.

      Using manufacturer (RSA biomedical, Umsa Sweden) provided beads and injector gun, four to
      five 1 mm tantalum beads will be placed in the coracoid, acromion and glenoid. 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. 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 shoulder joint kinematics and implant
      position have used this methodology of bead placement with successful study related outcomes.
      Investigators have successfully placed bone beads in 22 patients currently treated in the
      ongoing IRI clinical study without any difficulty or adverse events during or after surgery.

      Postoperatively, all patients will receive a CT with Metal Artifact Reduction (MAR)and RSA
      (if chosen) within 3 weeks of surgery. This will be a CT Scan performed with the patient's
      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 1 year (± 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,
      produced with a different body and arm position, also decreases metal artifact than those
      obtained with the arm placed by the side. This position cannot be comfortably obtained until
      3- 6 months after surgery and require healing of the tissues and rehabilitation of the
      shoulder. Investigators 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 postoperative CT scans are placed
      back into the surgical software and the 3D reconstruction of the postoperative scapula with
      the implants is compared to the preoperative plan. Using measurement tools within the
      software, developed at the Cleveland Clinic, investigators 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).

      Preoperatively, the high resolution quantitative CT will measure volumetric bone mineral
      density and the trabecular network of the glenoid. When available, this will be applied to
      the preoperative CT for those patients at Cleveland Clinic, Main Campus. Patients who have
      their preoperative CT completed at non Main Campus facilities will have the standard of care
      preoperative CT. This will be done at the same visit for the standard of care preoperative
      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, investigators will have data to properly determine the quality of the bone
      stock surrounding the implant. Further correlating these data with RSA and 3D CT imaging of
      implant movement, investigators can fully develop cause and effect of bone quality on glenoid
      component loosening.

      Study Statistics and Analysis:

      Our goal is to have 20 subjects in each of the 4 treatment groups for a total of 80 subjects.
      To control for subject withdrawal for various reasons after enrollment, we will enroll up to
      120 subjects.

      Statistical analysis plan:

      Average deviations from plan for the 4 treatment groups will be compared using mixed-effects
      ANOVA methods. Random effects will be included to account for correlation between
      observations introduced as a consequence of multiple observations of deviation being taken on
      a particular surgeon. If significant differences are found, multiple comparisons based on the
      ANOVA model will be made to compare each pair of groups, and will use Holm's step-down
      procedure to control the family-wise error rate of the tests.

      All analyses will be done by Colin O'Rourke of Quantitative Health Sciences at Cleveland
      Clinic using R software (version 3.0.0, Vienna, Austria). A significance level of 5% will be
      used for all testing.
    

Intervention name(s): DePuy Global® Anchor Peg Glenoid Instrumentation; DePuy Global® Anchor Peg Instrumentation with SmartBone™; IRI with SmartBone™; RTI with SmartBone™; IRI with SmartBase
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.; Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.; Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.; Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.; Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anatomic Total Shoulder Arthroplasty; Glenoid; Patient-specific instrumentation; Computer simulation; Computer assisted tomography