Possesses combined functionality and benefits of a cervical interbody and an anterior cervical plate.
A New Foundation for Growth
The TrellOss-C SA Porous Ti Interbody System is a stand-alone anterior cervical interbody fusion system intended for use at one or two contiguous levels.
A 3D printed titanium interbody platform featuring a scaffold structure with 70% porosity and a 7 micron roughened surface topography to foster a cellular relevant environment for adhesion and bone ingrowth.1
- TrellOss-C SA possesses combined functionality and benefits of a cervical interbody and an anterior cervical plate.
- Scaffolding structure provides additional surface area 2,3 and an elastic modulus similar to PEEK.8
- Implant is contained within the region of the excised disc space and is designed to not protrude past the mid-line edge of the vertebral bodies, reducing the amount of soft tissue damage or irritation.
- Implants are sterile-packed for reduced risk of contamination and hospital reprocessing costs.
- Roughened surface provides initial stabilization and integrated turn lock allows for visual confirmation of locked position.
- 7 micron surface texturing enhances the wicking nature9 and creates an environment for potential cellular adhesion.2,3,4
- Aligned pore structure allows optimal fluoroscopy when assessing fusion post-operatively.
- Open architecture with 70% porosity including varying pore sizes of 300, 500, and 700 microns that mimic cancellous bone allowing for a conducive environment for cellular activity.1,5,6,7
12 mm x 15 mm, 14 mm x 16 mm, 16 mm x 18 mm*.
*16 mm x 18 mm footprint is non-standard.
5 mm–12 mm*.
*10 mm -12 mm heights are non-standard.
3.5 mm and 4.0 mm.
12, 14, 16, and 18 mm.
TrellOss is a collection of additively manufactured implants. The TrellOss-C SA Porous Ti Interbody System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have 300-700μm pores. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with a turn lock mechanism that secures the screw to the spacer component.
The TrellOss-C SA Porous Ti Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The TrellOss-C SA Porous Ti Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The TrellOss-C SA Porous Ti Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
The TrellOss-C SA Porous Ti Interbody System contraindications include, but are not limited to:
- The presence of infection, pregnancy, metabolic disorders of calcified tissues, grossly distorted anatomy, inadequate tissue coverage, any demonstrated allergy or foreign body sensitivity to any of the implant materials, drugs/alcohol abuse, mental illness, general neurological conditions, immunosuppressive disorders, morbid obesity, patients who are unwilling to restrict activities or follow medical advice, and any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
- Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, the use of anticoagulants, etc. all have a negative effect on bony union. Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation.
- Any condition not described in the Indications for Use.
- Prior fusion at the level(s) to be treated.
- Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in building a construct.
- The TrellOss-C SA Porous Ti Interbody System devices should be implanted only by surgeons who are fully experienced in the use of such implants and the required specialized spinal surgery techniques. Prior to use, surgeons should be trained in the surgical procedures recommended for use of these devices.
- The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant. Based on the dynamic testing results, the physician should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of the device.
- These devices are provided as single use only implants and are not to be reused or re-implanted regardless of an apparent undamaged condition.
- The TrellOss-C SA Porous Ti Interbody System is used to augment the development of a spinal fusion by providing temporary stabilization. If fusion is delayed or does not occur, material fatigue may cause breakage of the implant. Damage to the implant during surgery (i.e., scratches, notches) and loads from weight bearing and activity will affect the implant’s longevity.
- The correct handling of the implant is extremely important. Use care in handling and storage of devices. Store the devices in a clean, dry area away from radiation and extreme temperatures and corrosive environments such as moisture, air, etc.
- Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.
- Components of this system should not be used with components of any other system or manufacturer.
- Potential risks identified with the use of this system, which may require additional surgery, include: device component breakage, loss of fixation/loosening, non-union, vertebral
Potential complications and adverse effects for this system are similar to those of other spinal instrumentation systems and include, but are not limited to: pseudarthrosis, insufficient bone stock, painful bursa, pressure necrosis, palpable components, early or late loosening of the components; disassembly, bending or breakage of any or all of the components; foreign body (allergic) reaction to the implants; possible infections requiring removal of devices; loss of neurological function, including paralysis, spinal cord impingement or damage.
- McGilvray KC, Easley J, Seim HB, et al. Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model. Spine J 2018;18(7):1250-1260.
- Olivares-Navarrete R, Hyzy SL, Slosar PJ et al. Implant materials generate different peri-implant inflammatory factors: poly-ether-ether-ketone promotes fibrosis and microtextured titanium promotes osteogenic factors. Spine 2015;40(6):399 -404.
- Olivares-Navarrete R, Hyzy SL, Gittens RA, et al. Rough titanium alloys regulate osteoblast production of angiogenic factors. Spine J 2013;13(11):1563 -70.
- Rao PJ, Pelletier MH, Walsh WR, et al. Spine Interbody Implants: Material Selection and Modification, Functionalization and Bioactivation of Surfaces to Improve Osseointegration. Orthop Surg 2014;6:81 -89.
- Ponader S, von Wilmowsky C, Widenmayer M, et al. In vivo performance of selective electron beam-melted ti-6al-4v structures. J Biomed Mater Res A 2010;92A:56 -62.
- Li JP, Habibovic P, et al.: Bone ingrowth in porous titanium implants produced by 3D fiber deposition. Biomaterials 2007;28:2810.
- Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials 2005;26(27):5474 -91.
- Permeswaran, V., (2019) Elastic Modulus Characterization of Porous Titanium TrellOss™ Structure, 2922.1-GLBL-en-REV1219, Zimmer Biomet Spine, Westminster, CO
- Permeswaran, V., (2019) Measuring the Wicking Nature of Porous Titanium TrellOss™ Structure, 2921.1-GLBL-en-REV1219, Zimmer Biomet Spine, Westminster, CO
Nexxt Spine, LLC
14425 Bergen Blvd, Suite B
Noblesville, IN 46060