Clinical Use of a New Nano-Hydroxyapatite/Polyamide66 Composite Artificial Lamina in Spinal Decompression Surgery: More Than 4 Years’ Follow-Up
Zenghui Zhao, Liang Guo, Yong Zhu, Wei Luo, Yunsheng Ou, Zhengxue Quan, Dianming Jiang
Department of Orthopedics, The First Afﬁliated Hospital of Chongqing Medical University, Chongqing, China (mainland)
Med Sci Monit 2018; 24:5573-5579
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