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

ABSTRACT

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 21 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.