BACKGROUND: A number of surgical options exist for decompressing lumbar foraminal stenosis. Flexible shaver foraminotomy is a recent addition to this armamentarium. While the foraminotomy device has been incorporated into clinical practice, the literature on its safety and efficacy remain limited. We aimed to evaluate nerve safety, pain relief, and patient satisfaction in a series of patients treated with the iO-Flex shaver system (Amendia, Inc., Marietta, Georgia). METHODS: Thirty-one consecutive patients with lumbar foraminal stenosis underwent foraminal decompression using the flexible microblade shaver system at 62 neuroforamina. The shavers were inserted into each foramen using an open hemilaminotomy and fluoroscopic guidance. Nerve mapping via mechanomyography (MMG) was used to ensure nerve safety. Perioperative charts were reviewed to find the incidence of neurologic complications and to quantify pain relief. Average office-based follow-up was 5.3 months. A 3-item questionnaire was administered to assess patient satisfaction during late follow-up, which occurred at an average of 21 months. RESULTS: No planned iO-Flex foraminotomies were aborted. Neurologic complications included transient dysesthetic pain in 1 patient (3.2%, n = 31), and transient numbness in 3 patients (9.7%, n = 31). There were no motor deficits. The composite nerve complication rate was 12.7%. Preoperative visual analog scale scores decreased from a mean of 7.1 (n = 31, standard deviation [SD] 2.0) to a mean of 3.5 (n = 30, SD 2.5). If asked to repeat their decision to do surgery, 81% of patients would redo the procedure. The rate of patient dissatisfaction was 19%. CONCLUSIONS: Decompression of lumbar foramina using the flexible shaver system and MMG nerve mapping is safe and effective, although the short-term sensory complication with this technique may be higher than previously reported. Patient satisfaction with iO-Flex foraminotomy is comparable to reported satisfaction outcomes for traditional lumbar decompression. LEVEL OF EVIDENCE: 4.
BACKGROUND: A number of surgical options exist for decompressing lumbar foraminal stenosis. Flexible shaver foraminotomy is a recent addition to this armamentarium. While the foraminotomy device has been incorporated into clinical practice, the literature on its safety and efficacy remain limited. We aimed to evaluate nerve safety, pain relief, and patient satisfaction in a series of patients treated with the iO-Flex shaver system (Amendia, Inc., Marietta, Georgia). METHODS: Thirty-one consecutive patients with lumbar foraminal stenosis underwent foraminal decompression using the flexible microblade shaver system at 62 neuroforamina. The shavers were inserted into each foramen using an open hemilaminotomy and fluoroscopic guidance. Nerve mapping via mechanomyography (MMG) was used to ensure nerve safety. Perioperative charts were reviewed to find the incidence of neurologic complications and to quantify pain relief. Average office-based follow-up was 5.3 months. A 3-item questionnaire was administered to assess patient satisfaction during late follow-up, which occurred at an average of 21 months. RESULTS: No planned iO-Flex foraminotomies were aborted. Neurologic complications included transient dysesthetic pain in 1 patient (3.2%, n = 31), and transient numbness in 3 patients (9.7%, n = 31). There were no motor deficits. The composite nerve complication rate was 12.7%. Preoperative visual analog scale scores decreased from a mean of 7.1 (n = 31, standard deviation [SD] 2.0) to a mean of 3.5 (n = 30, SD 2.5). If asked to repeat their decision to do surgery, 81% of patients would redo the procedure. The rate of patient dissatisfaction was 19%. CONCLUSIONS: Decompression of lumbar foramina using the flexible shaver system and MMG nerve mapping is safe and effective, although the short-term sensory complication with this technique may be higher than previously reported. Patient satisfaction with iO-Flex foraminotomy is comparable to reported satisfaction outcomes for traditional lumbar decompression. LEVEL OF EVIDENCE: 4.
Authors: Lawrence D Dickinson; Jeffery Phelps; Christopher D Summa; Jed S Vanichkachorn; Winston R Jeshuran; Jeffrey B Randall; Ronnie I Mimran; Michelle Mitchell; Mitchell M Macenski; Carl Lauryssen Journal: J Spinal Disord Tech Date: 2013-12
Authors: Carl Lauryssen; Sigurd Berven; Ronnie Mimran; Christopher Summa; Michael Sheinberg; Larry E Miller; Jon E Block Journal: Clin Interv Aging Date: 2012-07-20 Impact factor: 4.458
Authors: Rubana H Chowdhury; Mamun B I Reaz; Mohd Alauddin Bin Mohd Ali; Ashrif A A Bakar; K Chellappan; T G Chang Journal: Sensors (Basel) Date: 2013-09-17 Impact factor: 3.576