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 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.

• Authors: Hyun Bae, Homer Paul Hatten Jr, Raymond Linovitz, A David Tahernia, Michael K Schaufele, Vance McCollom, Louis Gilula, Philip Maurer, Ramsin Benyamin, John M Mathis, Maarten Persenaire
• Journal: Spine (Spine (Phila Pa 1976)) Vol. 37 Issue 7 Pg. 544-50 (Apr 01 2012) ISSN: 1528-1159 [Electronic] United States
• PMID: 21738093 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• CORTOSS
• Bisphenol A-Glycidyl Methacrylate
• Polymethyl Methacrylate

Topics

• Adult
• Aged
• Aged, 80 and over
• Bisphenol A-Glycidyl Methacrylate (therapeutic use)
• Comparative Effectiveness Research
• Female
• Follow-Up Studies
• Fractures, Compression (surgery)
• Humans
• Male
• Middle Aged
• Pain Measurement
• Polymethyl Methacrylate (therapeutic use)
• Prospective Studies
• Spinal Fractures (surgery)
• Treatment Outcome
• Vertebroplasty (instrumentation, methods)