Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion.

OBJECTIVE: Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion. METHODS: Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1-S1) specimens. A finite element analysis study evaluated clinical stability of the device to pedicular screw-rod fixation at L4-L5. Preliminary clinical results were assessed by analysis of Manufacturer and User Facility Device Experience database complications, and 6-month outcomes in 13 patients treated with the device. RESULTS: Among 35 curved drill holes in 5 lumbar specimens, no breaches of the anterior cortex were identified. The mean minimum distance from the anterior surface of the hole to the spinal canal ranged from 5.1 mm at L1-L2 to 9.8 mm at L5-S1. In the finite element analysis study, the polyetheretherketone strap provided comparable clinical stability and reduced anterior stress shielding compared to the conventional screw-rod construct. The Manufacturer and User Facility Device Experience database identified 1 device fracture with no clinical sequelae among 227 procedures. Initial clinical experience showed a 53% decrease in pain severity (P = 0.009), a 50% decrease in Oswestry Disability Index (P < 0.001), and no device-related complications. CONCLUSIONS: Cortico-pedicular fixation is a safe and reproducible procedure that may address limitations of pedicle screw fixation. Longer term clinical data in large clinical studies are recommended to confirm these promising early results.

Retrospective analysis of unstaged and staged Gamma Knife surgery with and without preceding embolization for the treatment of arteriovenous malformations.

OBJECT: The authors conducted a retrospective study to examine data on rates of obliteration of arteriovenous malformations (AVMs) with use of various combinations of treatment modalities based on Gamma Knife surgery (GKS). The authors believe that this study is the first to report on patients treated with embolization followed by staged GKS. METHODS: The authors identified 150 patients who underwent GKS for treatment of AVMs between 1994 and 2004. In a retrospective study, 4 independent groups emerged based on the various combinations of treatment: 92 patients who underwent unstaged GKS, 28 patients who underwent embolization followed by unstaged GKS, 23 patients who underwent staged GKS, and 7 patients who underwent embolization followed by staged GKS. A minimum of 3 years of follow-up after the last GKS treatment was required for inclusion in the retrospective analysis. Angiograms, MR images, or CT scans at follow-up were required for calculating rates of obliteration of AVMs. RESULTS: Fifty-seven of 150 patients (38%) supplied angiograms, and overall obliteration was confirmed in 43 of these 57 patients (75.4%). An additional 37 patients had follow-up MR images or CT scans. The overall obliteration rate, including patients with follow-up angiograms and patients with follow-up MR images or CT scans, was 68 of 94 (72.3%). Patients who underwent unstaged GKS had a follow-up rate of 58.7% (54 of 92) and an obliteration rate of 75.9% (41 of 54). Patients who underwent embolization followed by unstaged GKS had a follow-up rate of 53.5% (15 of 28) and an obliteration rate of 60.0% (9 of 15). Patients who underwent staged GKS had a follow-up rate of 82.6% (19 of 23) and an obliteration rate of 73.7% (14 of 19). Patients who underwent embolization followed by staged GKS had a follow-up rate of 85.7% (6 of 7) and an obliteration rate of 66.7% (4 of 6). CONCLUSIONS: Gamma Knife surgery is an effective means of treating AVMs. Embolization prior to GKS may reduce AVM obliteration rates. Staged GKS is a promising method for obtaining high obliteration rates when treating larger AVMs in eloquent locations.