The Endoskeleton TT system should not be used with components of any other interbody systems. The Titan Spine Endoskeleton TT Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. They have a Maximum TT value of 1,250 PED. As with all orthopedic implants, the Endoskeleton TT Interbody Fusion Device should never be reused under any circumstances. 0000356069 00000 n
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Titan Endoskeleton TT and OsteoSponge/BMA The Endoskeleton TT ( Fig.
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��$"�8j���q��2yb/���q�N"��ԧ�:2C�Q���������025���l�lj��c9�G�bq�3GR��v@t�i ꜎�9M@#�S �a�Ė,#�c�>�O�DJt~w��J{��ߦS$9崫�X�:I��(j���d9�P��sT}�V�e.���M�c������j��HQ��G ��fƢ7.DKƬ�|������uD�L�����J To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. It has not been tested for heating, migration, or image artifact in the MR environment. Any other concurrent medical disease that might impair normal healing process. The patient should be instructed in the limitations of his/her metallic implant(s) and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing. Supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. The superior and inferior surfaces include either the Chemtex™ surface treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. The study, titled ”Transforaminal Lumbar Interbody Fusion Rates in Patients Using a Novel Titanium Implant and Demineralized Cancellous Allograft Bone Sponge,” reported positive results with the use of Bacterin’s OsteoSponge, a demineralized cancellous bone product for spinal fusion procedures, and Titan Spine’s Endoskeleton TT titanium cage and autograft bone. 0000355831 00000 n
One hundred and fifty (150) subjects will participate in the study at a max of 15 clinical sites.
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The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation. 0000563456 00000 n
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The Titan Spine Endoskeleton TO Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. Macro textures on the superior and inferior surfaces promote immediate mechanical fixation. ), Osteoporosis defined as a DEXA bone density measurement T score ≤ 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care). 0000022286 00000 n
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The implants are composed of ASTM F136 or ASTM F3001 Ti 6Al-4V ELI titanium alloy and are provided either sterile or non-sterile. 0000578822 00000 n
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The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. 0000139977 00000 n
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The Endoskeleton TT Interbody Fusion Device should never be implanted in patients with a systemic or local infection. 0000004845 00000 n
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�� C�%����[�.ƍ*�n�TKɥ��WEd1�E�yx]�Î�0G�%�*�K���M��H@Qe�s@�^v�QBe��a\v�n����-�\5�V�?��>wU�w>�穨(��mH��Nb��R�i���nPpH � B��������C- TM��0j3��;�R0RM! Talk with your doctor and family members or friends about deciding to join a study. This is a prospective, multi-center controlled observational clinical study. 0000027354 00000 n
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The patient should be warned to avoid falls or sudden jolts in spinal position. 0000189949 00000 n
Contouring of the implants is to be avoided. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features.
An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used. Patients who smoke have been shown to have an increased incidence of nonunion. Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. 0000044397 00000 n
You may at any time change the settings regarding cookies. Supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used.
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Other conditions may exist where safety and effectiveness have not been established. Inspect internal and external threads for damage prior to assembly. In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity. They typically do not have a minimum trade terminal value.
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This site uses cookies to store information on your computer. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI). Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone. 0000557104 00000 n
The type of construct to be assembled for the case should be determined prior to beginning the surgery. The Endoskeleton TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) used in pairs oriented longitudinally from posterior to anterior and a 31 mm length for use in angled or Oblique single placement treatment across the disc space, and are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/ or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. 0000405062 00000 n
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trailer
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The Endoskeleton TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.
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