Lumbar-sacral Destruction Fixation Biomechanics

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Lumbar-sacral Destruction Fixation Biomechanics PIs: Jwalant S. Mehta, MD and Vijay K. Goel, PhD, David S. Marks FRCS (Orth) Trainee: Amin Joukar, BS Birmigngham Spine Centre, England Engineering Center for Orthopedic Research Excellence (E-CORE) The University of Toledo, Toledo, OH W W W. N S F C D M I. O R G

Background Instrumenting the spinal column with lumbo-sacral deficiency is a challenge The deficiency can occur with destruction following tumors or in a lumbo-sacral deficient model Developed a customized/innovative implant Have used in 4 cases (3 sacral agenesis and 1 Neurofibromatosis)

Clinical Need and Industrial Relevance Current Options and Challenges Dunn MacCarthy hooks Bio-mechanically not a sound implant Implant bulk and prominence Migration, loosening Requires a good host bone stock

Clinical Need and Industrial Relevance Current Options and Challenges contd. Iliac bolts Bulky implants Need to have an offset connector further increases bulk Requires strong host bone for purchase of large diameter screws

Clinical Need and Industrial Relevance Current Options and Challenges contd. S2AI construct Best option in the intact spine Inadequate / deficient anchor host bone

Clinical Need and Industrial Relevance Tuning Fork plate, Concept Evolution Idea started with a VSP bent over and placed securely over intact Iliac crest Evolved to the concept of a tuning fork that straddles the intact Iliac crest providing a strong distal fix with screws Fix in the thoracic spine / rib anchor points proximally.

Clinical Need and Industrial Relevance Tuning Fork plate The 2 prongs of the tuning fork plate straddle the crest and are held with screws through the holes Proximal construct varies with the available anchors

Clinical Need and Industrial Relevance Tuning Fork plate Variable proximal construct Distal fix with Tuning fork plate

Project Aims Assess the bio-mechanical profile of the tuning fork plate compared to a standard S2AI pelvic fixation in a lumbo-sacral deficient model. Would help clarify indications and clinical profiling for the use of the tuning fork plate a new concept.

Methods 6 specimens in each of the two groups, Group I and Group II Osteoporotic on DEXA scans X-rays for the specimens

Methods for the two groups Group I: S2AI pelvic fixation Group II: Tuning fork plate Stabilization T10 L2 with 6.5 mm pedicle screws L3 Sacrum removed _Deficiency Model Tuning fork plate with flanges contoured and locking screws inserted to fix the tuning fork to the pelvis The rod of the implant contoured and fixed into the proximal pedicle screws

Methods FE modeling for comparison Prepare FE models of the above construct protocols using our platform FE Model technology Compute stresses, strains, load sharing and compare the two groups

Milestones & Timeline Milestones Finishing model development December 31, 2016 Data collection July, 2017 Data analysis August 31, 2017

Deliverables Quarterly presentation updates: December 2016 conference call Spring 2017 Spring Symposium @ UT (conference call option for non-ut teams) June 2017 conference call September 2017 Fall Symposium @ UCSF (conference call option for non-ucsf teams) Final written report including results - October 31, 2017 Specific work product (e.g. abstracts, manuscripts and potential new concept)

Proposed Budget General Budget Outline Personnel $25,000 Imaging $1,000 Cadaver specimens $10,000 Total Direct $36,000 In directs (10%) $3,600 Total $39,600