J Korean Neurosurg Soc.  2022 Sep;65(5):730-740. 10.3340/jkns.2022.0028.

Safety and Efficacy of Bone Cement (Spinofill^®) for Vertebroplasty in Patients with Osteoporotic Compression Fracture : A Preliminary Prospective Study

• Park HB
• Son S
• Jung JM
• Lee SG
• Yoo BR

• KMID: 2533035
• DOI: http://doi.org/10.3340/jkns.2022.0028

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, 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%) 1 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.

Keyword

Compression fracture; Vertebra; Vertebroplasty; Bone cements; Polymethyl methacrylate; Spinofill

Figure

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  Fig. 1. Diagram of recruitment and study process.

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  Fig. 2. Classification of cement leakage : type I, epidural leakage via the basivertebral vein or fracture defect; type II, cortical leakage through cortical defect; type III, disc space leakage through end plate defect; and type IV, vascular leakage via the segmental vein.

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  Fig. 3. Lateral plain radiograph showing measured factors. The mean height of the vertebral body was defined as the average of the three area heights of the vertebral body ([a+b+c] / 3). The vertebral height ratio was calculated using the following equation : the vertebral height ratio (%) = mean height of the index level / [(mean height of the upper adjacent body + mean height of the lower adjacent body) / 2] × 100. Segmental kyphotic angle (X) was determined at the intersection of lines drawn at the superior plateau of vertebral body and the inferior plateau of vertebral body.

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  Fig. 4. Kaplan-Meier analysis of recurrence-free survival rate.

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  Fig. 5. Composition of Spinofill® (Injecta Inc., Gunpo, Korea).

Reference

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