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The in vivo response to a novel Ti coating compared with polyether ether ketone: evaluation of the periphery and inner surfaces of an implant
- Source :
- The Spine Journal. 18:1231-1240
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Increasing bone ongrowth and ingrowth of polyether ether ketone (PEEK) interbody fusion devices has the potential to improve clinical outcomes.This study evaluated the in vivo response of promoting new bone growth and bone apposition with NanoMetalene (NM) compared with PEEK alone in a cancellous implantation site with an empty aperture.This is a randomized control animal study.Implants and funding for this study were provided by SeaSpine (60,000 USD). Cylindrical dowels with two apertures were prepared as PEEK with a sub-micron layer of the titanium (NM). The titanium coating was applied over the entire implant (Group 1) or just the apertures (Group 2). Polyether ether ketone implants with no coating served as controls (Group 3). Implants were placed in the cancellous bone of the distal femur or proximal tibia with no graft material placed in the apertures in eight adult sheep. Bone ongrowth to the surface of the implant and ingrowth into the apertures was assessed at 4 and 8 weeks after surgery with micro-computed tomography (CT) and undecalcified histology.The apertures in the implants were notably empty in the PEEK group at 4 and 8 weeks. In contrast, new bone formation into the apertures was found in samples coated with NM even though no graft material was placed into the defect. The bone growing into the aperture tracked along the titanium layer. Apertures with the titanium coating demonstrated significantly more bone by micro-CT qualitative grading compared with PEEK with average bone coverage scores of Group 1 (NM) 1.62±0.89, Group 2 (NM apertures only) 1.62±0.77, and Group 3 (PEEK) 0.43±0.51, respectively, at 4 weeks (p.01) and Group 1 (NM) 1.79±1.19, Group 2 (NM apertures only) 1.98±1.18, and Group 3 (PEEK) 0.69±0.87, respectively, at 8 weeks (p.05). The amount of bone in the apertures (ingrowth) quantified using the volumetric data from the micro-CT supported an overall increase in bone volume inside the apertures with the titanium coating compared with PEEK. Histology showed newly formed woven bone tracked along the surface of the titanium in the apertures. The PEEK interface presented the typical nonreactive fibrous tissue inside the apertures at 4 weeks and some focal contact with bone on the outside at 4 weeks and 8 weeks.Micro-CT and histology demonstrated bone ongrowth to the surfaces coated with NM where the newly formed bone tracked along the thin titanium-coated surfaces. Polyether ether ketone surfaces presented the nonreactive fibrous tissue at the interface as previously reported in preclinical scenarios.
- Subjects :
- Polymers
medicine.medical_treatment
chemistry.chemical_element
Context (language use)
Prosthesis Design
Bone and Bones
Polyethylene Glycols
Benzophenones
Random Allocation
03 medical and health sciences
Polyether ether ketone
chemistry.chemical_compound
0302 clinical medicine
Osseointegration
medicine
Peek
Animals
Orthopedics and Sports Medicine
Titanium
Bone growth
030222 orthopedics
Sheep
business.industry
Prostheses and Implants
X-Ray Microtomography
Ketones
medicine.anatomical_structure
chemistry
Spinal fusion
Surgery
Neurology (clinical)
Implant
business
Cancellous bone
030217 neurology & neurosurgery
Biomedical engineering
Subjects
Details
- ISSN :
- 15299430
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- The Spine Journal
- Accession number :
- edsair.doi.dedup.....42be49e7df94c5336251505a4799fa6f