A Prospective Randomized FDA-IDE Trial Comparing Cortoss With PMMA for Vertebroplasty

Abstract

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.

Bone graft substitutes currently available in orthopaedic practice

“…Five RCTs were considered to be Level I evidence and the results showed that the substitutes were equal or superior to autograft. [13][14][15][16][17] Four were multicentre studies conducted in the United States, 13,14,16,17 and the study by Lerner et al 15 was performed at one centre in Germany. Both studies involving Alpha-BSM (DePuy) declared funding from industry, whereas the studies using Norian SRS (Synthes), Cortoss (Orthovita) and Vitoss (Orthovita) did not.…”

“…After critical appraisal of the literature only five papers from four products, Alpha-BSM (DePuy, Leeds, United Kingdom), Cortoss (Orthovita, St Albans, United Kingdom), Norian SRS (Synthes, Welwyn Garden City, United Kingdom) and Vitoss (Orthovita), were considered to have Level I published data equal to or superior to autograft. [13][14][15][16][17] Types of bone graft substitute. Demineralised bone matrix (DBM).…”

“…Both studies involving Alpha-BSM (DePuy) declared funding from industry, whereas the studies using Norian SRS (Synthes), Cortoss (Orthovita) and Vitoss (Orthovita) did not. Three studies reported the method of random sequence generation 14,16,17 but only three recorded the process of allocation concealment, two with the use of sealed envelopes 15,16 and the other using an independent worker pulling consective tabs. 14 Inclusion and exclusion criteria were reported in four studies.…”

Subsequent Fractures Post–Vertebral Augmentation: Analysis of a Prospective Randomized Trial in Osteoporotic Vertebral Compression Fractures

“…21 The study was conducted at 21 US sites by 38 investigators selected on the basis of their experience in using PMMA in vertebroplasty. Sample size was calculated by using the Farrington and Manning Maximum Likelihood Method, 22 which yielded a size requirement of 207 patients-138 in treatment and 69 controls.…”

Bioactive glass-containing cranial implants: an overview

“…Use of epoxy polymer has been criticized due to potential toxic and allergic effects of its monomers, which are present as residuals in the FRC [46,47,52]. On the other hand, thermoset polymers made of dimethacrylate monomer systems of BisGMA have shown good biocompatibility after careful polymerization before insertion of the material to tissues [53,54] However, when the BisGMA monomers are allowed to polymerize in situ, for example, as bone cement, the biocompatibility of the cement has been questioned [55,56].…”