11 August 2018 : Clinical Research
Clinical Use of a New Nano-Hydroxyapatite/Polyamide66 Composite Artificial Lamina in Spinal Decompression Surgery: More Than 4 Years’ Follow-UpZenghui Zhao1AE, Liang Guo2C, Yong Zhu1F, Wei Luo1D, Yunsheng Ou1A*, Zhengxue Quan1D, Dianming Jiang3G
Med Sci Monit 2018; 24: CLR5573-5579
BACKGROUND: Long-term follow-up results showed that epidural scar formation and adhesion after laminectomy always affected the outcomes of repeat operations. The establishment of a barrier between scar tissue and dura was effective in preventing epidural scar formation.
MATERIAL AND METHODS: A nano-hydroxyapatite/polyamide66 (n-HA/PA66) artificial lamina was designed and fabricated and used to cover the opened spinal canal in patients who received laminectomy. The visual analogue scale (VAS) and Japanese Orthopedic Association (JOA) Scores, X-ray, computed tomography, and magnetic resonance imaging results were periodically recorded and evaluated.
RESULTS: All patients were followed up for 4–7 years, with an average period of 5.2 years. The clinical symptoms improved significantly after surgery, as the JOA scores were significantly improved after the operation and maintained to last follow-up when compared with preoperative ones (P<0.05). The vertebral canal became noticeably enlarged, from 16.7±4.7 mm to 32.9±2.2 mm, after surgery and well maintained to 32.1±1.8 mm. The lumbar lordosis was well maintained after surgery. No rupture, absorption, or dislodgement of the n-HA/PA66 lamina was found. MRI showed the spinal canal had the correct morphology, with no stenosis, no obvious scar formation, and no nerve roots or epidural sac compression.
CONCLUSIONS: The artificial lamina is a reasonable choice for prevention of epidural scar formation after laminectomy, in spite of the results from a small sample of cases.
Keywords: Clinical Trial, Laminectomy, Prostheses and Implants
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