| Safety and Efficacy of Bone Cement (Spinofill®) for Vertebroplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study |
Han Byeol Park
, Seong Son
, Jong Myung Jung
, Sang Gu Lee
, Byung Rhae Yoo
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| Department of Neurosurgery, Gil Medical Center, Gachon University College of Medicine |
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Received: February 8, 2022; Revised: March 17, 2022 Accepted: April 8, 2022. Published online: May 17, 2022. |
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| ABSTRACT |
Objective
Although several commercialized bone cements are used during percutaneous vertebroplasty (PVP) for patients with osteoporotic vertebral compression fracture (OVCF), there are no reports using domestic products from South Korea. In this study, we investigated the safety and efficacy of Spinofill® (Injecta Inc., Gunpo, South Korea), a new polymethyl methacrylate product.
Methods
A prospective, single-center, and single-arm clinical trial of 30 participants who underwent PVP using Spinofill® for painful thoracolumbar OVCF was performed with 6-months follow-up. Clinical and surgical outcomes included the visual analog scale (VAS), Korean-Oswestry Disability Index (K-ODI), and Odom’s criteria, complication rate, and recurrence rate. Radiological outcomes were evaluated by measuring the findings of postoperative computed tomography and simple radiograph.
Results
The pain of VAS (from 8.95±1.05 to 4.65±2.06, p<0.001) and the life quality based on K-ODI (from 33.95±5.84 to 25.65±4.79, p<0.001) improved significantly, and successful patient satisfaction were achieved in 20 patients (66.7%) one day after surgery. These immediate improvements were maintained or more improved during the follow-up. There was no surgery- or product-related complications, but OVCF recurred in two patients (6.7%). Favorable cement interdigitation was reported in 24 patients (80.0%), and extra-vertebral cement leakage was reported in 13 patients (43.0%). The mean vertebral height ratio (from 60.49±21.97 to 80.07±13.16%, p<0.001) and segmental kyphotic angle (from 11.46±8.50 to 7.79±6.08°, p=0.002) improved one day after surgery. However, these short-term radiological findings somewhat regressed at the end.
Conclusion
The overall outcomes of PVP using Spinofill® were as favorable as those of other conventionally used products. |
| Key Words:
lumbar spine, compression fracture, vertebroplasty, bone cement, polymethyl methacrylate |
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