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STUDY DESIGN A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. OBJECTIVE The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. METHODS Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months. RESULTS At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P

Study design Retrospective case series review of patients with Parkinson's disease undergoing elective spine surgery at a single tertiary referral center. Objectives To assess the rate of complications of spine surgery in the population with Parkinson's disease and characterize the causes of failure and special needs of this unique population. Summary of background data Patients with Parkinson's disease experience a combination of poor bone quality and a severe neuromuscular disorder. There is little information in the literature about outcomes of spine surgery in this population. Preliminary review suggests that these patients have a high rate of instrument-related complications that has not been reported previously. Methods A computerized search using diagnostic and procedural codes identified 14 patients with Parkinson's disease who underwent spine surgery from January 1993 through December 2000. Their charts and radiographs were reviewed, and those not examined within twelve months were invited for follow-up review. The remaining patients were being followed on a regular basis by their spine surgeon, the Movement Disorders Clinic, or both and were seen and examined during their routine follow-up observation. INDICATIONS AND EXTENT OF INDEX SURGERY VARIED: Complications, revisions, and radiographic evidence of loosening were assessed. Causes of failure were sought with respect to surgical and clinical factors. All patients underwent surgical care by a fellowship-trained spine surgeon. Results The mean follow-up period from index procedure was 66.8 months; the median follow-up period was 38 months. Of 14 patients, 12 (86%) required additional surgery, undergoing a total of 31 reoperations. Eleven patients (79%) underwent 22 additional procedures at the same or adjacent level for instability, including four patients (29%) who had hardware failure or pullout, necessitating 10 reoperations. The one other patient who required additional surgery had a successful index procedure but underwent another operation to address instability at a remote spinal segment. Of five patients whose index procedure involved only one spinal level, three (60%) required additional procedures, all at that level. Two patients (14%) developed wound infections during the course of treatment but not as the cause of initial treatment failure. The primary mechanisms of failure were relentless kyphosis or segmental instability at the operated-on or adjacent levels. Conclusion Patients with Parkinson's disease undergoing spine surgery in a single tertiary referral center had a very high reoperation rate associated with technical complications. Patients should be appropriately counseled regarding the increased risk of operative complications and closely followed for incipient failure.

Study design A case-controlled, comparative study of 400 patients undergoing lumbar surgery, treated with either spinal or general anesthesia. An independent observer analyzed outcomes. Objectives To determine the rate and type, of perioperative complications associated with each anesthetic method among lumbar surgery patients. Summary of background data Spinal anesthesia is infrequently used for spinal procedures. While complications associated with spinal anesthesia are rare, some authors have suggested that spinal anesthesia may exacerbate existing neurologic disease and have recommended against its use in lumbar disc surgery. Others have found the technique safe and effective. General anesthesia may be preferred because it is seen as the routine accepted practice, because of greater patient acceptance and the ability to perform longer operations, or because of a general sense that general anesthesia is "safer" in these procedures. Methods Patients treated between 1994 and 1998 were matched for anesthetic class, preoperative diagnosis, surgical procedure, and perioperative protocols. All patients were treated according to a uniform protocol and recovered in the same perianesthetic environment. Data from the intraoperative period through hospital discharge were collected and compared. Results A total of 200 patients were included in each group. Overall complication rates and time to discharge were significantly lower in spinal anesthetic patients. Total anesthetic and operative times were significantly longer for general anesthetic patients, and perioperative heart rate and mean arterial pressures were elevated compared with those in spinal anesthetic patients. Nausea, requirements for antiemetic medication, and the incidence of urinary retention were significantly increased among general anesthesia patients. Spinal anesthesia patients had fewer spinal headaches compared with the general anesthetic group, but statistical significance was not obtained. Conclusions For patients undergoing decompressive lumbar surgery, spinal anesthesia is at least comparable to general anesthetic with respect to complications. Specific advantages to spinal anesthesia include decreased nausea and antiemetic requirements, reduced analgesic requirements, and reduced overall complication rate.