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Cortoplasty- Treatment of Vertebral Compression Fractures with Cortoss for Vertebral Augmentation; Preliminary Results of Prospective Randomized Clinical Trial 2007

Interventional Spine

H. Paul Hatten, MD

Scientific Paper

Purpose

The purpose of this study is to assess the safety and efficacy of the treatment of osteoporotic vertebral compression fractures with Cortoss (1) as compared to a commercially available PMMA. This study is being conducted under an FDA Investigational Device Exemption and is the first Prospective Randomized Clinical Trial for Cortoss.

Methods & Materials

A total of 19 sites are to enroll 243 patients in the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS and 81 patients treated using a PMMA bone cement). Patient outcome will be assessed by VAS, ODI, SF-12 and maintenance of height and alignment at the level(s) treated. Patients evaluations are to be done at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. A minimum VAS of 50, a minimum ODI of 30%, an osteoporotic compression fracture at one or two levels, presence of edema on MRI or bone scan and an informed consent are the inclusion criteria. The exclusion criteria includes greater than 70% collapse, canal compromise, neurologic deficit at the level (s) to be treated or tumors. Post-operative CT and radiographs are being used to assess and quantify leakage.

Results

To date, 44 patients have been enrolled; 19 treated using a PMMA bone cement and 25 treated using CORTOSS. The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group. A total of 56 vertebral levels have been treated; 25 in the PMMA treated group and 35 in the CORTOSS treated group. The average volume of material injected in the CORTOSS treated group was 1.17 cc and 2.41cc in the PMMA treated group. Leakages were observed on post-op CT scans and found to be similar in both groups. All extravasations were asymptomatic with no cardio-pulmonary complications. Improvement in VAS (see Figure 1) and ODI was similar for both groups out to 12 months.

Conclusion

These preliminary results suggest that Cortoss provides similar pain relief compared to PMMA with 30% less material. This is due to the distinct interdigitated fill pattern obtained with Cortoss. These results are consistant with those obtained in the prospective vertebroplasty study using Cortoss conducted in Europe(2).

References

1. Palussiere J, Berge J, Gangi A, Cotton A, Pasco A, Bertagnoli R, Jackshe H, Carpeggiani P, Deramond H, Clinical Results of an Open Prospective Study of a bis-GMA Composite in Percutaneous Vertebral Augmentation, European Spine Journal, 2005.
2. Erbe, E., Clineff, T., Gualtieri, G., 'Comparison of a new bisphenol-a-glycidyl dimethacrylate-based cortical bone void filler with polymethyl methacrylate' Eur Spine J (2001) 10:S147-S152.

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