Combining percutaneous pedicular and extrapedicular access for tumor ablation in a thoracic vertebral body.

We present a percutaneous modified technique to access large thoracic vertebral body lytic lesions, to increase the volume of tumor accessible to ablation, prior to cement augmentation. Tumor ablation and cavity creation-assisted percutaneous vertebroplasty was considered a palliative measure for structural stabilization in plasmocytoma involvement of the entire T8 vertebral body. Given the extent of osteolysis bilateral combined transpedicular and extrapedicular access to the vertebral body was undertaken to maximize the volume of cavity creation within the tumor. The combined transpedicular and extrapedicular access was feasible, uncomplicated, and successful in reaching all the quadrants of the anterior two thirds of the vertebral body. Slow, fluoroscopically monitored injection of high-viscosity cement resulted in a successful, desired cement distribution into the anterior two thirds of the vertebral body, spanning superior to inferior endplates, providing structural stability, in the absence of venous or epidural leakage. The technical modification described in this case yielded positive results while overcoming some of the limitations of the existing coblation device. This approach may offer an option for cement augmentation of extensive vertebral body lytic lesions, at increased risk for tumor displacement and extra-vertebral cement leakage.

A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up.

STUDY DESIGN: Randomized, controlled, prospective (AAOS therapeutic level I) trial conducted under Food and Drug Administration Investigational Device Exemption hypothesized noninferiority of a novel bioactive composite material to polymethylmethacrylate (PMMA). OBJECTIVE: To determine the safety and efficacy of a new, nonresorbable bioactive composite (Cortoss) compared with PMMA, the standard treatment of vertebral compression fractures (VCFs). SUMMARY OF BACKGROUND DATA: Vertebroplasty with PMMA, the widely adopted treatment for VCFs nonresponsive to conservative care, provides effective, immediate pain relief, but the material has received criticism for its properties. A new bioactive composite material designed specifically for vertebroplasty showed promising results in animals and nonrandomized clinical studies and was subsequently compared with PMMA in a randomized study. This study represents the first prospective study evaluating vertebroplasty comparing PMMA with another material with 24-month follow-up. METHODS: Using 2:1 randomization, vertebroplasty was performed with Cortoss on 162 patients and PMMA on 94 patients. Inclusion criteria were painful osteoporotic VCFs with a visual analogue scale pain score of at least 50 mm on a 100-mm scale and at least 30% disability as measured by the Oswestry Disability Index. Evaluations at pretreatment, treatment day, and 7 posttreatment intervals out to 24 months included pain, disability, neurological status, adverse events, quality of life, patient satisfaction, analgesic use, and independently reviewed radiographs. RESULTS: Noninferiority of Cortoss relative to PMMA was observed, with Cortoss-treated patients experiencing significant pain relief at 3 months (P = 0.0395) and better maintenance or improvement in function at 24 months (P = 0.0299). Incidence of serious device-related adverse events was 4.3% in both groups; none were life threatening. CONCLUSION: Vertebroplasty using either Cortoss or PMMA provides effective, immediate, and lasting pain relief and prevents further loss of function. Both materials performed comparably at most time points; Cortoss demonstrated better results for pain reduction at 3 months and for function at 24 months.