Since its introduction in the 1970s percutaneous treatment of lumbar disc herniation has been an attractive concept that has been the object of technical development and clinical application throughout the world. Little scientific evaluation of the efficacy and effectiveness of the procedure has been done. To estimate the success rates of automated percutaneous and conventional discectomy in comparable patients and to document the resource consumption of patients treated in these ways, a multicenter randomized clinical trial designed to compare both treatment efficacy and cost-effectiveness of automated percutaneous discectomy and conventional discectomy in adult patients with no prior lumbar spinal surgery, no coexistent lumbar spinal disease, unilateral single level lumbar radiculopathy with images confirming disc herniation at the appropriate level. In the course of the trial important technical advances allowing epidural extraction of free-fragment disc herniation was incorporated into the trial. It was not possible to enroll the required number of patients to complete the trial. Of 5735 screened patients, 95 were eligible and 36 were enrolled. Two elected watchful waiting and did not have any surgical procedure. Eight patients were lost to follow-up. Among the 27 evaluable patients, 41% of the percutaneous discectomy patients and 40% of the conventional discectomy patients were assessed as achieving "success" on the primary outcome measure. No clinical trial of any percutaneous discectomy technique provides definitive evidence supporting the efficacy or effectiveness of the procedure. Such evidence should be required by patients to whom such procedures are proposed and those who are asked to pay for them.
Copyright 2002 Elsevier Science Ltd.