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Functional Recovery From the Utilization of Processed Nerve Allografts for Large Gap Nerve Discontinuities: Outcomes From a National Registry Study
REFERENCES 1. Stahl S, Santos Stahl A, Meisner C, Rahmanian-Schwarz A, Schaller HE, Lotter O. A systematic review of the etiopathogenesis of Kienböck’s disease and a critical appraisal of its recognition as an occupational disease related to hand-arm vibration. BMC Musculoskelet Disord. 2012;13:225. 2. Stahl S, Hentschel P, Lotter O, et al. Prospective case-control study on the etiopathology of Kienböck’s disease. Plast Reconstr Surg. 2013;133(3):324ee334e. 3. Stahl S, Santos Stahl A, Rahmanian-Schwarz A, et al. An international opinion research survey of the etiology, diagnosis, therapy and outcome of Kienböck’s disease (KD). Chir Main. 2012;31(3):128e137.
studies, qualitative questionnaires and safety assessments. Reported outcomes data were incorporated into the MRCC scale for sensory and motor function. Meaningful recovery was defined as ¼ S3/M3 on the MRCC scale with higher thresholds of recovery defined at S3þ/M4 or greater. Results: The current RANGER registry has sufficient quantitative outcomes data on 135 nerve repairs. From this population, the long gap cohort consisted of 39 injuries (19 sensory, 17 mixed, and 3 motor nerves) occurring in 32 study subjects. Mean age of the cohort was 39 16.4 (19e70) years and was predominantly male at 71.9%. Mean gap length was 36 8.9 (30e65) mm with a mean follow up time of 308 165 days. Meaningful recovery was observed in 87% of repairs with 59% reaching higher thresholds of function. Analysis by nerve type observed meaningful recovery in 95% of sensory, 82% of mixed, and 67% of motor nerve repairs. Meaningful recovery for subgroups: injury location, mechanism of injury, and time to repair are detailed in Table 1.0. No adverse events were reported. Summary Points: Processed nerve allograft demonstrated meaningful recovery in sensory, mixed, and motor nerve injuries between 30 and 65 mm. Overall meaningful recovery was reported at 87% with outcomes consistent across subgroups No adverse events or revisions were reported. These outcomes compare favorably to historical data in the literature for nerve autograft. The registry remains ongoing and continues to collect outcomes data on the use of processed nerve allografts for long gap nerve reconstructions.
PAPER 06 Best Papers Thursday, September 18, 2014 2:44e2:49 PM Category: Treatment, Surgical Technique, Prognosis/Outcomes Keyword: Hand and Wrist, Elbow and Forearm, Shoulder and Arm, Nerve
Functional Recovery From the Utilization of Processed Nerve Allografts for Large Gap Nerve Discontinuities: Outcomes From a National Registry Study N/A - Not a clinical study
© © © ©
Bauback Safa, MD Jeffrey A. Greenberg, MD Wesley P. Thayer, MD, PhD Jason H. Ko, MD Mickey Cho, MD Gregory M. Buncke, MD
Hypothesis: Long gap nerve repair injuries provide a significant challenge, especially when available autograft donor nerve is inadequate. We studied the functional recovery outcomes of processed nerve allografts for the repair of long gap nerve injuries between 30 mm and 65 mm to determine their efficacy in this application. Methods: The RANGER Study is a multicenter registry designed to collect data on the use of processed nerve allografts (AvanceÒ Nerve Graft, AxoGen, Inc). IRB approval was obtained and standardized data reports were used to collect utilization, safety and functional outcomes. The registry database was queried for nerve repairs measuring ¼ 30mm reporting sufficient quantitative data to determine the outcome of the repair. The long gap cohort was further stratified into nerve type, injury location, mechanism of injury and time to repair subgroups. Reported sensory and/or motor assessments included 2-point discrimination, Semmes-Weinstein Monofilament (SMW) testing, range of motion, electromyography (EMG)
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REFERENCES 1. Brooks D, Weber RV, Chao J, et al. Processed nerve allografts for peripheral nerve reconstruction: a multicenter study of utilization and outcomes in sensory, mixed, and motor nerve reconstructions. Microsurgery. 2012;32(1):1e14. 2. Cho MS, Rinker BD, Weber RV, et al. Functional outcome following nerve repair in the upper extremity using processed nerve allograft. J Hand Surg Am. 2012;37(11):2340e2349. 3. Kallio PK, Vastamäki M. An analysis of the results of late reconstruction of 132 median nerves. J Hand Surg Br. 1993;18(1):97e105. 4. Ruijs AC, Jaquet JB, Kalmijn S, Giele H, Hovius SE. Median and ulnar nerve injuries: a meta-analysis of predictors of motor and sensory recovery after modern microsurgical nerve repair. Plast Reconstr Surg. 2005;116(2):484e494. discussion 495e496. 5. Frykman G, Gramyk K. Results of nerve grafting. In: Gelberman R, ed. Operative Nerve Repair and Reconstruction. Philadelphia: JB Lippincott; 1991:553e568.
Consulting Fee: AxoGen Inc (Safa) Consulting Fee: AxoGen Inc (Buncke)
© Speaker has nothing of financial value to disclose
studies, qualitative questionnaires and safety assessments. Reported outcomes data were incorporated into the MRCC scale for sensory and motor function. Meaningful recovery was defined as ¼ S3/M3 on the MRCC scale with higher thresholds of recovery defined at S3þ/M4 or greater. Results: The current RANGER registry has sufficient quantitative outcomes data on 135 nerve repairs. From this population, the long gap cohort consisted of 39 injuries (19 sensory, 17 mixed, and 3 motor nerves) occurring in 32 study subjects. Mean age of the cohort was 39 16.4 (19e70) years and was predominantly male at 71.9%. Mean gap length was 36 8.9 (30e65) mm with a mean follow up time of 308 165 days. Meaningful recovery was observed in 87% of repairs with 59% reaching higher thresholds of function. Analysis by nerve type observed meaningful recovery in 95% of sensory, 82% of mixed, and 67% of motor nerve repairs. Meaningful recovery for subgroups: injury location, mechanism of injury, and time to repair are detailed in Table 1.0. No adverse events were reported. Summary Points: Processed nerve allograft demonstrated meaningful recovery in sensory, mixed, and motor nerve injuries between 30 and 65 mm. Overall meaningful recovery was reported at 87% with outcomes consistent across subgroups No adverse events or revisions were reported. These outcomes compare favorably to historical data in the literature for nerve autograft. The registry remains ongoing and continues to collect outcomes data on the use of processed nerve allografts for long gap nerve reconstructions.
PAPER 06 Best Papers Thursday, September 18, 2014 2:44e2:49 PM Category: Treatment, Surgical Technique, Prognosis/Outcomes Keyword: Hand and Wrist, Elbow and Forearm, Shoulder and Arm, Nerve
Functional Recovery From the Utilization of Processed Nerve Allografts for Large Gap Nerve Discontinuities: Outcomes From a National Registry Study N/A - Not a clinical study
© © © ©
Bauback Safa, MD Jeffrey A. Greenberg, MD Wesley P. Thayer, MD, PhD Jason H. Ko, MD Mickey Cho, MD Gregory M. Buncke, MD
Hypothesis: Long gap nerve repair injuries provide a significant challenge, especially when available autograft donor nerve is inadequate. We studied the functional recovery outcomes of processed nerve allografts for the repair of long gap nerve injuries between 30 mm and 65 mm to determine their efficacy in this application. Methods: The RANGER Study is a multicenter registry designed to collect data on the use of processed nerve allografts (AvanceÒ Nerve Graft, AxoGen, Inc). IRB approval was obtained and standardized data reports were used to collect utilization, safety and functional outcomes. The registry database was queried for nerve repairs measuring ¼ 30mm reporting sufficient quantitative data to determine the outcome of the repair. The long gap cohort was further stratified into nerve type, injury location, mechanism of injury and time to repair subgroups. Reported sensory and/or motor assessments included 2-point discrimination, Semmes-Weinstein Monofilament (SMW) testing, range of motion, electromyography (EMG)
e6
REFERENCES 1. Brooks D, Weber RV, Chao J, et al. Processed nerve allografts for peripheral nerve reconstruction: a multicenter study of utilization and outcomes in sensory, mixed, and motor nerve reconstructions. Microsurgery. 2012;32(1):1e14. 2. Cho MS, Rinker BD, Weber RV, et al. Functional outcome following nerve repair in the upper extremity using processed nerve allograft. J Hand Surg Am. 2012;37(11):2340e2349. 3. Kallio PK, Vastamäki M. An analysis of the results of late reconstruction of 132 median nerves. J Hand Surg Br. 1993;18(1):97e105. 4. Ruijs AC, Jaquet JB, Kalmijn S, Giele H, Hovius SE. Median and ulnar nerve injuries: a meta-analysis of predictors of motor and sensory recovery after modern microsurgical nerve repair. Plast Reconstr Surg. 2005;116(2):484e494. discussion 495e496. 5. Frykman G, Gramyk K. Results of nerve grafting. In: Gelberman R, ed. Operative Nerve Repair and Reconstruction. Philadelphia: JB Lippincott; 1991:553e568.
Consulting Fee: AxoGen Inc (Safa) Consulting Fee: AxoGen Inc (Buncke)
© Speaker has nothing of financial value to disclose