Prospective clinical trial.
Demonstrate the safety and efficacy of gelified ethanol in the percutaneous treatment of lumbar disk hernias.
After the commercial withdrawal of Chymopapain, the need for new substances to treat intervertebral disk hernias was evident. Good results were obtained with pure ethanol, but this substance was difficult to handle. We decided to use a similar substance mixed with ethylcellulose to increase its viscosity and enhanced with radiopaque material.
Two hundred seventy-six consecutive patients sent to be treated of a lumbar intervertebral disk hernia percutaneously were included in this preliminary study and treated with radiopaque gelified ethanol (RGE) and intra-articular steroids. Three groups were set, group A for patients to be treated only with RGE and groups B and C for difficult cases presenting a narrow canal, foraminal hernia, or hiperalgic sleepless hernia, treated with RGE plus another intradiscal technique, automatized percutaneous diskectomy for group B and radiofrequency nucleoplasty for group C.
Very good or good results were obtained in 202 (91.4%) of the 221 patients in group A. Of the 44 patients in group B, 37 patients (84%) presented very good or good results and in 9 (82%) of the 11 patients of group C, we obtained similar results. There was no allergic complication in any of our patients. Short-term follow-up with magnetic resonance showed little or no changes in the intervertebral disk but there was discordance with clinical signs. Long-term follow-up magnetic resonance showed a dramatic reduction in hernia volume.
This preliminary study shows the efficacy and inocuity of this new substance that could take over the Chymopapain therapeutic field.
*Department of Neuroradiologie, CHU Côte de Nacre, Avenue de la Côte de Nacre, Caen, France
†Clínica Nuestra Señora del Rosario, Madrid
‡Hospital General de Cataluña, Barcelona, Spain
Reprints: Jacques Theron, MD, Department of Neuroradiologie, CHU Côte de Nacre, Avenue de la Côte de Nacre, Caen, France 14000 (e-mail: email@example.com).
Received for publication July 14, 2006; accepted January 8, 2007