title: Discectomy strategies for lumbar disc herniation: study design and implications for clinical research.
abstract: Although previous studies have found automated percutaneous discectomy and epidural percutaneous discectomy to be less efficacious than conventional discectomy, these percutaneous procedures may be effective and cost-effective as a first surgical treatment for herniated lumbar disc. Percutaneous procedures for herniated lumbar disc continue to be performed throughout the world without definitive evidence of efficacy or effectiveness. The objective of this article is to report the design considerations and final design of a study with the following objectives: (1) to estimate the efficacy of automated percutaneous and conventional discectomy in treating single level herniated lumbar discs in comparable patient populations, and (2) to test the hypothesis that the use of percutaneous discectomy as the first surgical procedure in such patients would result in less cost and fewer complications than utilizing conventional discectomy as the first procedure. A multicenter randomized clinical trial was designed that followed published eligibility criteria closely, allowed flexibility in timing of surgery (while collecting natural history information on patients identified before electing surgery), incorporated adjustments for newly developed technology and accommodated the unusual demands of assessing a procedure acknowledged to have inferior medical outcomes when compared to conventional therapy but which offered potential advantages in cost and safety. The study was successfully designed and funded. In its implementation we experienced several obstacles that may affect the success of other clinical trials. Despite using established eligibility criteria, our patient enrollment was lower than expected. Academic health centers and traditional research settings are seeing fewer patients who would be eligible for discectomy; private clinical centers are treating eligible patients but lack the incentives to participate in clinical research. Automated percutaneous discectomy and epidural percutaneous discectomy are widely performed procedures and, despite the aforementioned obstacles, their efficacy and cost-effectiveness need to be scientifically evaluated if we are committed to delivering appropriate patient care.
authors.affiliation: Department of Neurological Surgery, Medical University of South Carolina, Charleston, South Carolina 29425, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Haines
authors.forename: Neil
authors.initials: N
authors.lastname: Jordan
authors.forename: James R
authors.initials: JR
authors.lastname: Boen
authors.forename: John A
authors.initials: JA
authors.lastname: Nyman
authors.forename: Neil B
authors.initials: NB
authors.lastname: Oldridge
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Lindgren
mesh_terms: D003362:Cost-Benefit Analysis; D017586:Diskectomy; D006801:Humans; D007258:Informed Consent; D007405:Intervertebral Disc Displacement / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D015337:Multicenter Studies as Topic / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*