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Vertebral Augmentation: 2 year Clinical Experience in a Prospective Randomized Controlled FDA Study in Vertebroplasty Comparing Cortoss [C] to PMMA [P] 2009

Interventional Spine

Louis A. Gilula, MD,

Scientific Paper

Mentor Award: No

Institution where work was conducted

Barnes Jewish Hospital

Affiliation and Department

Professor of Radiology, Orthopedics and Plastic and Reconstructive Surgery

Address

Mallinckrodt Institute of Radiology, Washington University, Barnes Jewish Hospital
510 South Kingshighway
St. Louis, Missouri
63110
Phone: 314-362-2916, Fax: 314-362-4660
Email: gilulal@mir.wustl.edu

Purpose

The clinical goals of vertebral augmentation in treating osteoporotic vertebral compression fractures include immediate reduction in pain, maintenance or improvement in function and stabilization of remaining vertebral architecture. The purpose of the study is to compare the results of two products used in PVP: one designed for vertebroplasty that has unique properties allowing bone ingrowth and smaller volume(s) of injectate compared to PMMA which has been adapted to vertebroplasty. This is the first prospective controlled study comparing two products for PVP with long term objective follow up.

Methods & Materials

256 pts with osteoporotic vertebral fractures (VCF) were enrolled in a prospective randomized IDE study comparing C (162 pts) and P (94 pts) between 2004 and 2007. Study criteria limited severity of the fracture to loss of up to 30% of original height and excluded vertebra plana and gross instability. Patients were followed for 24 months post-treatment.

Results

The median age of participants was 78 years; 74% were female. 34% of patients entered the study with previous fractures. In total 315 levels, from T6 to L5, were treated (201 C and 114 P) with a majority of the fractures occurring at or near the thoracolumbar junction. On average, 2.3cc’s of C and 3.6cc’s of P were used per treated vertebral body. Average VAS pain scores improved in both groups ≥78mm at baseline to 20.1mm (C) and 21.3mm (P) at 24-Months. C demonstrated a significantly better improvement in pain than P at the 3-Month interval (p<0.05). Function improved from baseline disability of ~ 60% to 25.3% (C) and 28.1% (P) at 24-Months. Stability of the augmented level(s) was assessed by a blinded independent radiologist and defined as no change in gross morphology compared to the first post-operative weight bearing images. 97.5% of C and 100% of P maintained vertebral height and alignment at 24 months. Complications in both groups mirrored the types and frequencies of those reported in the literature. 68.5% of C and 68.1% of P patients exhibited leaks. 12% fewer C than P patients experienced subsequent vertebral fractures, 27.2 vs. 30.9%.

Conclusion

C is as safe and effective in vertebral augmentation as P while requiring less material to achieve the same clinical effect. Lower volumes of material contribute to a lower risk profile to the patient.

Keywords
Vertebroplasty, FDA, IDE, Cortoss, PMMA, vertebral compression fractures (VCF), PVP (percutaneous vertebroplasty procedures).

References

CORTOSS® Bone Augmentation Material is manufactured by Orthovita, Inc. of Malvern, PA. Cortoss has received a CE mark for commercial use in Europe and is currently under investigation in the US via an IDE clinical trial and is not yet approved for use.

Author: Louis Gilula, M.D.

Financial Disclosure: Nothing to Disclose

This submission has not been previously published or presented.