European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Randomized Controlled Trial Multicenter Study Comparative Study
Psychometric properties of the functional rating index in patients with low back pain.
The purpose of this study was to validate the psychometric properties of the functional rating index (FRI), establish the instrument's minimum clinically important difference (MCID), and compare its psychometric properties with the Oswestry questionnaire. ⋯ The FRI is less reliable than the Oswestry but appears to have comparable validity and responsiveness. Before the FRI can be recommended for widespread use in patients with neck and low back pain, it should be further tested in patients with neck pain.
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Multicenter Study
Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation.
In this open prospective trial, 53 patients with acute pain from osteoporotic vertebral fracture related to osteoporosis or malignancy underwent vertebral augmentation with a new bisphenol-a-glycidyl dimethacrylate (bis-GMA) resin (Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of Cortoss injected into a given vertebra. The procedure encompassed single and multiple injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). ⋯ A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to Cortoss were leakage of Cortoss from within the vertebral body at placement (12%), back pain (7%), and unspecified pain (7%). These results indicate that vertebral augmentation with Cortoss rapidly reduces pain, decreases disability, and improves physical functioning in patients with painful vertebral compression fractures.