Dataset Information

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

ABSTRACT:

Background

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium.

Methods

This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages.

Results

There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS???1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK?+?Ti patients achieved complete bony fusion. The PEEK?+?Ti group (n?=?49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls (n?=?49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused.

Conclusions

ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials.

Trial registration

Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

SUBMITTER: Kotsias A

PROVIDER: S-EPMC5410055 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

Kotsias Andreas A Mularski Sven S Kühn Björn B Hanna Michael M Suess Olaf O

Patient safety in surgery 20170428

<h4>Background</h4>Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium.<h4>Methods</h4>This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 1 ...[more]

PMID: 28465722

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Project description:BackgroundIn case of spinal cord compression behind the vertebral body, anterior cervical corpectomy and fusion (ACCF) proves to be a more feasible approach than cervical discectomy. The next step was the placement of an expandable titanium interbody in order to restore the vertebral height. The need for additional anterior plating with ACCF has been debatable and such technique has been evaluated by very few studies. The objective of the study is to evaluate radiographic and clinical outcomes in patients with multilevel degenerative cervical spine disease treated by stand-alone cages for anterior cervical corpectomy and fusion (ACCF).MethodsThirty-one patients (66.5 ± 9.75 years, range 53-85 years) were analyzed. Visual Analog Scale (VAS) and the 10-item Neck Disability Index (NDI) were assessed preoperatively and during follow-up on a regular basis after surgery and after one year at least. Assessment of radiographic fusion, subsidence, and lordosis measurement of Global cervical lordosis (GCL); fusion site lordosis (FSL); the anterior interbody space height (ant. DSH); the posterior interbody space height (post. DSH); the distance of the cage to the posterior wall of the vertebral body (CD) were done retrospectively. Mean clinical and radiographic follow-up was 20.0 ± 4.39 months.ResultsVAS-neck (p = 0.001) and VAS-arm (p < 0.001) improved from preoperatively to postoperatively. The NDI improved at the final follow-up (p < 0.001). Neither significant subsidence of the cages nor significant loss of lordotic correction were seen. All patients showed a radiographic union of the surgically addressed segments at the last follow up.ConclusionsApplication of a stand-alone expandable cage in the cervical spine after one or two-level ACCF without additional posterior fixation or anterior plating is a safe procedure that results in fusion. Neither significant subsidence of the cages nor significant loss of lordotic correction were seen.Trial registrationRetrospectively registered. According to the Decision of the ethics committee, Jena on 25th of July 2018, that this study doesn't need any registration. https://www.laek-thueringen.de/aerzte/ethikkommission/registrierung/ .

Project description:OBJECTIVE:Lumbar fusion with implantation of interbody cage is a common procedure for treatment of lumbar degenerative disease. This study aims to compare the fusion and subsidence rates of titanium (Ti) versus polyetheretherketone (PEEK) interbody cages after posterior lumbar interbody fusion and investigate the effect of clinical and radiological outcomes following fusion on patient-reported outcomes. METHODS:A systematic search strategy of 4 electronic databases (MEDLINE, Embase, Web of Science, and Cochrane) was conducted using different MeSH (medical subject headings) terms until January 2020. Pooled odds ratios (ORs) with 95% confidence intervals (CI) were calculated using fixed and random-effect models based upon the heterogeneity (I2) to estimate the association between interbody cages and the measured outcomes. RESULTS:A total of 1,094 patients from 11 studies were reviewed. The final analysis included 421 patients (38.5%) who had lumbar surgery using a Ti and/or a Ti-coated interbody cage and 673 patient (61.5%) who had lumbar surgery using a PEEK cage. Overall, PEEK interbody devices were associated with a significantly lower fusion rate compared with Ti interbody devices (OR, 0.62; 95% CI, 0.41-0.93; p = 0.02). There was no difference in subsidence rates between Ti and PEEK groups (OR, 0.91; 95% CI, 0.54-1.52; p = 0.71). Also, there were no statistically significant differences in visual analogue scale (VAS)-low back pain (p = 0.14) and Japanese Orthopedic Association scale (p = 0.86) between the 2 groups. However, the PEEK group had lower odds of leg pain after surgery compared to the Ti group (OR [VAS-leg], 0.61; 95% CI, 0.28-0.94; p = 0.003). CONCLUSION:Ti and Ti-coated PEEK cages used for posterior lumbar interbody fusion are associated with similar rates of subsidence, but a higher rate of fusion compared to PEEK interbody cages. Randomized controlled trials are needed to better assess the effect of cage materials and potential factors that could influence the outcomes of interbody lumbar fusion.

Project description:The aim of this study was to evaluate the osseointegration of titanium implants (Ti-6Al-4V, noted here TA6V) and poly(etheretherketone) PEEK implants induced by a BMP-2-delivering surface coating made of polyelectrolyte multilayer films. The in vitro bioactivity of the polyelectrolyte film-coated implants was assessed using the alkaline phosphatase assay. BMP-2-coated TA6V and PEEK implants with a total dose of 9.3?g of BMP-2 were inserted into the femoral condyles of New Zealand white rabbits and compared to uncoated implants. Rabbits were sacrificed 4 and 8weeks after implantation. Histomorphometric analyses on TA6V and PEEK implants and microcomputed tomography on PEEK implants revealed that the bone-to-implant contact and bone area around the implants were significantly lower for the BMP-2-coated implants than for the bare implants. This was confirmed by scanning electron microscopy imaging. This difference was more pronounced at 4weeks in comparison to the 8-week time point. However, bone growth inside the hexagonal upper hollow cavity of the screws was higher in the case of the BMP-2 coated implants. Overall, this study shows that a high dose of BMP-2 leads to localized and temporary bone impairment, and that the dose of BMP-2 delivered at the surface of an implant needs to be carefully optimized.The presentation of growth factors from material surfaces currently presents significant challenges in academia, clinics and industry. Applying osteoinductive factors to different types of implants, made of metals or polymers, may improve bone repair in difficult situations. Here, we show the effects of an osteoinductive coating made of polyelectrolyte multilayer films on two widely used materials, titanium TA6V alloys and PEEK implants, which were implanted in the rabbit femoral condyle. We show that a too high dose of BMP-2 delivered from the screw surface has a negative short-term effect on bone regeneration in close vicinity of the screw surface. In contrast, bone formation was increased at early times in the empty spaces around the screw. These results highlight the need for future dose-dependence studies on bone formation in response to osteoinductive coatings.

Dataset Information

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

Background

Methods

Results

Conclusions

Trial registration

Publications

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

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