STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on fusion rates after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but little information exist on the effect in older patients. METHODS: A randomized clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized touninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Fusion rate was assessed at 2 year follow-up using thin slice CT. Functional outcome was assessed using Dallas Pain Questionnaire and Low Back Pain Rating Scale pain index. RESULTS.: Available follow-up after 2 years was 89% (84 of 95 patients). Fusion rates were surprisingly low. DC-stimulation had no effect on fusion rate: 35% versus 36% in controls. Other factors associated with low fusion rates were female gender (32% vs. 42% in males, P = 0.050) and smoking (21% vs. 42% in nonsmokers, P = 0.079). Patients who achieved a solid fusion as determined by CT had superior functional outcome and pain scores at their latest follow-up. CONCLUSION: Thin slice CT revealed very high nonunion rates after uninstrumented spinal fusion in older patients. DC-stimulation was not effective in increasing fusion rates in this patient population. The achievement of a solid fusion was associated with superior functional outcome.
RCT Entities:
STUDY DESIGN: Randomized, controlled, multi-center trial. OBJECTIVE: To investigate the effect of direct current (DC) electrical stimulation on fusion rates after lumbar spinal fusion in patients older than 60 years. SUMMARY OF BACKGROUND DATA: Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but little information exist on the effect in older patients. METHODS: A randomized clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Fusion rate was assessed at 2 year follow-up using thin slice CT. Functional outcome was assessed using Dallas Pain Questionnaire and Low Back Pain Rating Scale pain index. RESULTS.: Available follow-up after 2 years was 89% (84 of 95 patients). Fusion rates were surprisingly low. DC-stimulation had no effect on fusion rate: 35% versus 36% in controls. Other factors associated with low fusion rates were female gender (32% vs. 42% in males, P = 0.050) and smoking (21% vs. 42% in nonsmokers, P = 0.079). Patients who achieved a solid fusion as determined by CT had superior functional outcome and pain scores at their latest follow-up. CONCLUSION: Thin slice CT revealed very high nonunion rates after uninstrumented spinal fusion in older patients. DC-stimulation was not effective in increasing fusion rates in this patient population. The achievement of a solid fusion was associated with superior functional outcome.
Authors: Mit Balvantray Bhavsar; Zhihua Han; Thomas DeCoster; Liudmila Leppik; Karla Mychellyne Costa Oliveira; John H Barker Journal: Eur J Trauma Emerg Surg Date: 2019-04-06 Impact factor: 3.693
Authors: Thomas Andersen; Finn B Christensen; Bente L Langdahl; Carsten Ernst; Søren Fruensgaard; Jørgen Østergaard; Jens Langer Andersen; Sten Rasmussen; Bent Niedermann; Kristian Høy; Peter Helmig; Randi Holm; Niels Egund; Cody Bünger Journal: Biomed Res Int Date: 2013-08-19 Impact factor: 3.411