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Long-Term Follow-Up Results of Anterior Cervical Inter-Body Fusion with Stand-Alone Cages

Long-Term Follow-Up Results of Anterior Cervical Inter-Body Fusion with Stand-Alone Cages www.jkns.or.kr http://dx.doi.org/10.3340/jkns.2016.59.4.385 Print ISSN 2005-3711 On-line ISSN 1598-7876 Copyright 2016 The Korean Neurosurgical Society ( ) : J Korean Neurosurg Soc 59 4 385-391, 2016 Clinical Article Long-Term Follow-Up Results of Anterior Cervical Inter-Body Fusion with Stand-Alone Cages Woong-Beom Kim, M.D., Seung-Jae Hyun, M.D., Ph.D., Hoyong Choi, M.D., Ki-Jeong Kim, M.D., Tae-Ahn Jahng, M.D., Hyun-Jib Kim, M.D. Department of Neurosurgery, Spine Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea Objective : The purpose of this study was to evaluate long-term follow-up radiologic/clinical outcomes of patients who underwent anterior cervical discectomy and inter-body fusion (ACDF) with stand-alone cages (SAC) in a single academic institution. Methods : Total 99 patients who underwent ACDF with SAC between February 2004 and December 2012 were evaluated retrospectively. A total of 131 segments were enrolled in this study. Basic demographic information, radiographic [segmental subsidence rate, fusion rate, C2–7 global angle, and segmental angle changes)/clinical outcomes (by Odom’s criteria and visual analog score (VAS)] and complications were evaluated to determine the long-term outcomes. Results : The majority were males (55 vs. 44) with average age of 53.2. Mean follow-up period was 62.9 months. The segmental subsidence rate was 53.4% and fusion rate was 73.3%. In the subsidence group, anterior intervertebral height (AIH) had more tendency of subsiding than middle or posterior intervertebral height (p=0.01). The segmental angle led kyphotic change related to the subsidence of the AIH. Adjacent segmental disease was occurred in 18 (18.2%) patients. Total 6 (6%) reoperations were performed at the index level. There was no statistical significance between clinical and radiological outcomes. But, overall long-term clinical outcome by Odom’s criteria was unsatisfactory (64.64%). The neck and arm VAS score were increased by over time. Conclusion : Long-term outcomes of ACDF with SAC group were acceptable but not satisfactory. For optimal decision making, more additional com- parative long-term outcome data is needed between ACDF with SAC and ACDF with plating. Key Words : Anterior cervical discectomy and fusion · Stand-alone cage · Subsidence · Long-term outcomes · Intervertebral height · Odom’s criteria. we suggested that anterior plating may play a key role in the INTRODUCTION 2) support of anterior inter-body height . However, not a few stud- Anterior cervical discectomy and inter-body fusion (ACDF) ies have mentioned ACDF with SAC is a clinically/radiological- 11,16-18) with stand-alone cages (SAC) has been regarded as an accept- ly satisfactory procedure . However, there has been few able treatment option for symptomatic cervical degenerative long-term follow-up data about the ACDF with SAC. Further- disease. Not a few previous reports have described that ACDF more, most of recent published reports included two-year or 11) with SAC is satisfactory in terms of radiographic and clinical much lower follow-up period . 16-18) results . However, several investigators reported that the cage The purpose of this study was to evaluate the long-term follow- 13,14,24) subsidence and kyphotic angular change after the procedure . up radiographic and clinical outcomes of patients having ACDF Nevertheless, the subsidence rate and kyphotic segmental change with SAC in a single academic institution. was not significantly associated with clinical outcome in a short- 8,11) term follow-up series . MATERIALS AND METHODS About superior surgical outcomes among ACDF with SAC, ACDF with anterior plating or artificial disc are still controver- This study was approved by the institutional review board. Af- sial. We previously reported that ACDF with plating had better ter IRB approval, we retrospectively reviewed the records of all 13) radiologic outcome than stand-alone cage groups . In that study, patients treated with single-, two-, and three-level ACDF with SAC • : • : • : Received March 25, 2016 Revised March 25, 2016 Accepted May 6, 2016 • : Address for reprints Seung-Jae Hyun, M.D., Ph.D. Department of Neurosurgery, Spine Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82 Gumi-ro 173beon-gil, Seongnam 07061, Korea : : : Tel +82-31-787-7169, Fax +82-31-787-4097, E-mail hyunsj@snu.ac.kr • ( ) This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License http://creativecommons.org/licenses/by-nc/3.0 which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 385 J Korean Neurosurg Soc 59 | July 2016 from February 2004 to December 2012. Patients having cervical by follow-up magnetic resonance (MR) imaging and medical radiculopathy or myelopathy caused by cervical degenerative disc chart reviewing. disease and spondylosis who failed conservative management Subsidence was defined as a decrease of the total interverte- were included. The exclusion criteria included systemic infec- bral height (TIH) between the two adjacent vertebral bodies by tion, malignancy, C7/T1 involved disease, inability to measure comparing the lateral cervical radiographs. We compared the first the C2–7 angle because of a short neck, no clinical/radiographic postoperative, one-month, one-year, two-year standing radio- 21) follow-up data and less than 24 months follow-up period. Total graphs and the ultimate follow-up radiographs . The TIH was six spine surgeons performed the operations in those periods. measured by three portion; anterior, middle and posterior points Demographic information, radiological studies and clinical pre- of the upper end plate of the cranial vertebral body and the low- sentation were reviewed for each case before and after surgery. er end plate of the caudal vertebral bodies. More than 3 mm de- crease at any of the three points was considered to represent sig- 6,7) Surgical technique nificant subsidence (Fig. 1) . Smith and Robinson method was used for the approach to Fusion was defined as less than 2 mm change between the 19) the anterior cervical spine . Intervertebral disc, posterior lon- tips of the spinous processes of the treated level by the compar- gitudinal ligament and osteophyte were resected with endplate ing the flexion-extension lateral radiographs or definite bony preparation. In cases with radiculopathy, uncoforaminotomy bridge of the index level on a lateral plain radiograph or comput- 4) was utilized for the neural foraminal decompression. For deter- ed tomographic (CT) scan . The global cervical angle between mining the appropriate cage size, a trial cage was used. Poly- the C2 and C7 vertebrae was measured. The segmental angle ether-ether-ketone (PEEK) or carbon fiber cage filled with al- was defined as the angle between the upper end plate of the up- lograft or autograft cancellous bone obtained from the anterior per vertebral body and the lower end plate of the lower vertebral iliac crest were used for ACDF. The cage was located 1–2 mm body. Negative values of the segmental angle and the global cervi- 13,14) depth from the anterior margin of the vertebral body. Neck col- cal angle mean cervical lordosis . For clinical outcomes, Odom’s 25) lars were applied to the patients for 4–12 weeks after ACDF. criteria and visual analog scales (VAS) were used . We catego- rized Odom’s criteria as Excellent (1), Good (2), Fair (3), and Assessment of radiologic and clinical outcomes Poor (4). Then we reviewed all the medical records of the patients For radiologic outcomes, the cage subsidence, fusion rate, at the ultimate visit and the Odom’s criteria were filled out. Neck C2–7 global angle, and segmental angle were evaluated by the and arm VAS were checked pre- and postoperatively (annual plain radiographs. Adjacent segmental disease was investigated fashion), and the ultimate follow-up period of the index surgery. A B C D Fig. 1. A : Preoperative cervical spine lateral radiograph. B, C, and D : Postoperative cervical spine lateral radiograph show subsidence (B : Immediate postoperative standing radiograph, C : 1 month postoperative standing radiograph, D : Ultimate follow-up period radiograph). 386 Long-Term Outcome of ACDF with Stand-Alone Cages | WB Kim, et al. 131 segments were enrolled in this study. Surgical level was as Statistical analysis Pearson’s chi-square test was used for the baseline differences followed : 6 segments at C3/4, 25 segments at C4/5, 61 segments in nominal variables analysis. Student’s t-test and the Mann-Whit- at C5/6, and 39 segments at C6/7. Mean follow-up period was ney U test for parametric and nonparametric continuous vari- 62.9 (range, 28–135) months (Table 1). ables were used for the analysis of baseline characteristics be- Subsidence occurred in 70 (53.4%) segments and 57 (57.6%) tween the two groups, respectively. A repeated measure analysis patients at the ultimate follow-up period. Subsidence at anterior of variance (RM-ANOVA) of one between and one within mixed intervertebral height (AIH) was significant than middle interver- design was performed for radiologic and clinical outcomes be- tebral height (MIH) and posterior intervertebral height (PIH). Av- tween the subsidence (S-) and non-subsidence (NS-) groups, also erage 5.40 mm of subsidence of AIH was occurred at the ulti- fused (F-) and non-fused (NF-) groups. All data were analyzed mate follow-up and the subsidence was progressed over time using SPSS version 22 for Windows (SPSS Inc., Chicago, IL, USA). (p<0.001) in the S-group. However, the AIH change in the NS- group was only 1.33 mm and less progressed over time than the S-group (p<0.001). The MIH changes were 4.83 mm and pro- RESULTS gressed over time in the S-group, 1.07 mm and less progressed A total 367 patients underwent ACDF with SAC from Febru- over time in the NS-group at the ultimate follow-up period. The ary 2004 to December 2012. Finally, a total of 99 consecutive PIH subsidence was occurred less than AIH [incidence of 64.3% patients were included in this study. The majority were males (45 over 70 S-group)] with an average 3.93 mm change (p<0.001). (55 vs. 44) with average age of 53.2 (range, 23–81) years. The Comparing the TIH change in the S-group between 1 month post- number of ACDF with SAC at one-, two- and three-level was 68, operative and the ultimate follow-up data, 2.26 mm at AIH, 1.54 29, 2 patients, respectively. For each individual segment, a total mm at MIH, and 1.1 mm at PIH were observed (Table 2, Fig. 2). Table 1. Patient demographics with or without subsidence Baseline characteristics Subsidence (S-group) No subsidence (NS-group) p-value Number 70 61 Age 53.6±11.2 52.7±8.70 0.673 Gender (male : female) 36 : 21 19 : 23 0.058 BMD -1.25±1.50 -1.2±0.80 0.91 Level 0.28 C3/4 02 (2.9%) 04 (6.6%) C4/5 14 (20%) 11 (18%) C5/6 31 (44.3%) 30 (49.2%) C6/7 23 (32.9%) 16 (26.2%) Segmental angle, preoperative 0.92±4.99 0.78±3.67 0.97 TIH, preoperative 0.50 Anterior 34.07±3.20 34.45±3.10 Middle 32.86±3.14 33.26±2.85 Posterior 34.47±2.95 35.06±2.76 Global cervical angle, preoperative -12.05±10.5 -11.16±9.50 0.67 BMD : bone mineral density, TIH : total intervertebral height (mm) (mm) (mm) 39 37 38 34 33 S-group S-group S-group NS-group NS-group NS-group 29 29 31 Preop I-postop 1 month 1 yr 2 yr Ultimate Preop I-postop 1 month 1 yr 2 yr Ultimate Preop I-postop 1 month 1 yr 2 yr Ultimate AIH AIH AIH AIH F/U MIH MIH MIH MIH MIH F/U PIH PIH PIH PIH PIH F/U AIH A B C Fig. 2. A, B, and C : Preoperative, immediate standing postoperative, 1 month, 1 year, 2 year postoperative, and ultimate follow-up AIH, MIH, and PIH (anterior, middle, and posterior intervertebral height) change between S- and NS-group. S : subsidence, NS : non-subsidence, AIH : anterior interverte- bral height, MIH : middle intervertebral height, PIH : posterior intervertebral height. 387 J Korean Neurosurg Soc 59 | July 2016 The demographics and characteristics of both S- and NS- The fusion rate of ACDF with SAC at the ultimate follow-up groups are descripted in Table 1. There was no significant differ- was 73.3% by segmental analysis (96 out of 131 segments), and ence in age (p=0.673), gender (p=0.058), level of surgery (p= 70.7% by population (70 over total 99 patients). There was no 0.357) and bone mineral density (BMD) score (p=0.91) between statistical significance between fusion rate and subsidence rate S- and NS-groups. (p=0.158), and BMD score (p=0.058). Table 2. Radiologic and clinical outcomes after ACDF with SAC Postoperative outcomes Subsidence (S-group) No subsidence (NS-group) p-value VAS of neck pain Preoperative 5.93±3.67 6.23±3.05 <0.82 1 year 2.58±2.54 01.35±1.22 <0.80 2 year 3.92±2.73 02.91±2.70 <0.36 Ultimate follow-up 4.00±3.21 2.60±3.41 <0.30 VAS of arm pain < Preoperative 6.53±3.16 07.30±2.36 <0.47 1 year 2.89±2.76 02.06±1.95 <0.31 2 year 3.29±2.39 01.91±2.38 <0.17 Ultimate follow-up 4.57±3.50 03.20±3.19 <0.33 TIH, anterior (mm) <0.001 Immediate postop. 37.76±4.05 35.66±3.23 1 month 34.58±3.28 34.78±3.28 1 year 33.35±3.29 34.64±3.12 2 year 32.74±3.44 34.43±3.09 Ultimate follow-up 32.32±3.28 34.27±3.07 TIH, middle (mm) <0.001 Immediate postop. 36.52±3.76 34.19±3.17 1 month 33.20±2.73 33.43±2.84 1 year 32.52±2.90 33.32±2.96 2 year 32.20±2.90 33.24±3.08 Ultimate follow-up 31.66±3.04 33.14±3.07 TIH, posterior (mm) <0.001 Immediate postop. 37.47±3.42 35.38±3.06 1 month 34.62±2.81 34.76±2.68 1 year 34.54±2.85 34.64±2.98 2 year 34.36±2.93 34.41±3.05 Last follow-up 33.52±2.85 34.39±3.07 Cage height (mm) <0.85 5 10 (14.3%) 12 (19.7%) 6 42 (60%) 36 (59%) 7 13 (18.6%) 10 (16.4%) 8 04 (5.7%) 03 (4.9%) 9 01 (1.4%) 00 Segmental angle (°) <0.002 Immediate postop. -0.75±5.77 .-0.23±4.99 Ultimate follow-up 4.02±5.44 00.66±5.27 Global cervical angle (°) Immediate postop. -12.4±11.8 -12.7±9.60 <0.89 Ultimate follow-up -11.9±11.6 -12.7±11.2 <0.72 Fusion rate (%) Ultimate follow-up 69.05 78.33 <0.16 Radiating arm pain (%) Ultimate follow-up 54.30 39.30 <0.01 ACDF : anterior cervical discectomy and inter-body fusion, SAC : stand-alone cages, VAS : visual analog scales, TIH : total intervertebral height 388 Long-Term Outcome of ACDF with Stand-Alone Cages | WB Kim, et al. The kyphotic segmental angle change had statistical signifi- Fair+11 Poor)/99] had unsatisfactory clinical outcome. There cance between S- and NS-group (p=0.002). From -0.92 degree at was no statistical significance between fusion, subsidence and the immediate postoperatively to 4.03 degree at the ultimate fol- Odom’s criteria (p=0.813). The mean score of preoperative neck low-up was observed which was associated with the higher fre- and arm VAS were 6.89 and 6.07, 2.00 and 2.50 after 1 year the quency of AIH subsidence than the MIH or PIH change (Fig. 3). surgery, 3.48 and 2.68 after 2 year the surgery, 4.00 and 3.44 at However, the C2–7 global cervical angle had no statistical signif- the ultimate follow-up period (Fig. 4). Compared S- and NS- icance between the two groups (p=0.72). group with the neck and arm VAS, neck VAS at the ultimate Adjacent segmental disease was occurred in 18 (18.2%) patients. follow-up period was usually maintained but slightly aggravated Total 6 (6%) reoperations were performed due to following rea- than 1 year after surgery, and arm VAS was aggravated over sons : acute epidural hematoma formation (one patient), motor time in the both group (Fig. 5). Subsidence and fusion were not weakness aggravation (one patient) and neck or arm pain aggra- related to the neck or arm VAS (p>0.05) (Table 3). vations as late complications (four patients). By Odom’s criteria, 4 Excellent (1), 31 Good (2), 53 Fair (3), DISCUSSION and 11 Poor (4) patients’ answers were collected. Total average score of Odom’s criteria was 2.71. And 64.6% of patients [64 (53 This study revealed a radiologic and clinical long-term result with an over average 5-year follow-up data after ACDF with SAC (°) S-group Neck VAS NS-group Arm VAS Preop 1 month 1 year 2 year Ultimate FU Preop 1 year 2 year Ultimate FU -1 Fig. 3. The preoperative, 1 month, 1 year, and 2 year after surgery, and Fig. 5. The preoperative, 1 year, 2 year after surgery, and the ultimate ultimate follow-up segmental angle change between S- and NS-group. follow-up neck VAS vs. arm VAS change following over time in all ACDF Negative value means lordotic segmental angle. S : subsidence, NS : with SAC patients. VAS : visual analog scale, ACDF : Anterior cervical dis- non-subsidence. cectomy and inter-body fusion, SAC : stand-alone cages. 7 8 S-group S-group NS-group NS-group Preop 1 year 2 year Ultimate FU Preop 1 year 2 year Ultimate FU A B Fig. 4. A : The preoperative, 1 year, 2 year after surgery, and the ultimate follow-up neck VAS change between S- and NS-group. B : The preoperative, 1 year, 2 year after surgery, and the ultimate follow-up arm VAS change between S- and NS-group. S : subsidence, NS : non-subsidence, VAS : visual analog scale. 389 J Korean Neurosurg Soc 59 | July 2016 Table 3. Neck, arm VAS and subsidence, fusion at the ultimate follow-up period Neck VAS vs. Arm VAS S-group NS-group p-value F-group NF-group p-value Ultimate f/u Neck VAS 4.00±3.20 2.60±3.40 0.30 3.05±2.96 4.43±4.11 0.36 Ultimate f/u Arm VAS 4.57±3.50 3.20±3.19 0.33 3.72±3.32 4.83±3.71 0.49 S-group : subsidence group, NS-group : non-subsidence group, F-group : fused group, NF-group : non-fused group, f/u : follow-up, VAS : visual analog scale surgery. Up to date, there had been several reports that investi- VAS score meant different manner to previous reports showing gated about the outcomes of ACDF with SAC. However, most ACDF with SAC was suitable. Although we failed to find key fac- of the results were carried short or intermediate term data be- tors that affecting the inferior outcomes, it seems that ACDF low two-year of follow-up, or a few two-year follow-up data with with SAC surgery did not have superiority to the other ACDF small population. The main stream of the published data about techniques. Therefore, to treat patients of degenerative cervical results after ACDF with SAC included subsidence rate as below spine disease, various factors (age, general condition, surgical 30% to variable and fusion rate higher than 90% mostly without level, bone quality, segmental/global angle, with or without uncal significant clinical relationship, therefore, the researchers sug- resection) should be considered thoroughly for optimal care. gested that the outcome of the stand-alone cage procedure was The limitations of our study include its retrospective nature, 3,5,9-11,15-18,20,22,23) suitable . We previously reported one-year radio- the number of case limitations, the enrolled patients in this study logic and clinical outcomes of 3 different construct systems for were not randomized meaning biased data and the lack of com- single-level ACDF using SAC, iliac graft plus plate augmenta- paring control group or other ACDF procedure group. The op- tion, and cage plus plating. In that study, ACDF with SAC rep- erations were not performed by a single surgeon, and the de- resented higher subsidence rate (58.6%) and lower fusion rate tailed operation techniques like the extent of endplate preparation 13,14) (63.2%) . After following the previous patients in a long-term or the micro-damage impact to the anterior portion of the cer- fashion, it seemed to have inferior results in terms of subsidence vical vertebral body when the inter-body cages be tapped to be and fusion rate according to this study. 74.6% (53/71) of subsid- inserted to the intervertebral space were not standardized. De- ence occurred within the first 6 month after surgery, the other spite a long-term follow-up, the key factors were not identified 25.4% (18/71) subsidence segments occurred after 6 months. clearly for the unsatisfactory outcome of ACDF with SAC. Those However, the subsidence was progressed over time in the sub- are also a limitation of this study. In this circumstance, investi- sidence group even after postoperative one year but was not gations about other factors like, meta-analysis of environmental significantly progressed in the non-subsidence group. Several aspects or patients’ specific factors would be helpful for deter- reports described that the subsidence mostly occurred within mining the accurate outcome evaluation of ACDF surgery. one-year after surgery and then be stabled, meaning no more 12,13) progressed . However in this study, the subsidence was pro- CONCLUSION gressed over time slowly. 58.6% (41/70) of subsided segments were progressed over time continuously until the ultimate fol- Long-term outcomes of ACDF with SAC group were accept- low-up period. Moreover, the fusion rate of 73.3% meant the non- able but not satisfactory. For optimal decision making, more fused index segments did not achieve bone fusion eventually al- additional comparative long-term outcome data is needed be- though a long time past. tween ACDF with SAC and ACDF with plating. The relationships between the demographic data and radio- logic/clinical outcome had no statistical significance. This was References 1) similar to a previous report . The previous investigator demon- 1. Brenke C, Dostal M, Scharf J, Weiß C, Schmieder K, Barth M : Influence of cervical bone mineral density on cage subsidence in patients follow- strated that gender, age, level of surgery, cage height and BMD ing stand-alone anterior cervical discectomy and fusion. Eur Spine J 24 : had no significance as outcome factors of the ACDF with SAC 1) 2832-2840, 2015 surgery . 2. 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Long-Term Follow-Up Results of Anterior Cervical Inter-Body Fusion with Stand-Alone Cages

Kim, Woong-Beom; Hyun, Seung-Jae; Choi, Hoyong; Kim, Ki-Jeong; Jahng, Tae-Ahn; Kim, Hyun-Jib ... [+]
Journal of Korean Neurosurgical Society , Volume 59 (4) – Jul 8, 2016
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Pubmed Central
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Copyright © 2016 The Korean Neurosurgical Society
ISSN
2005-3711
eISSN
1598-7876
DOI
10.3340/jkns.2016.59.4.385
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www.jkns.or.kr http://dx.doi.org/10.3340/jkns.2016.59.4.385 Print ISSN 2005-3711 On-line ISSN 1598-7876 Copyright 2016 The Korean Neurosurgical Society ( ) : J Korean Neurosurg Soc 59 4 385-391, 2016 Clinical Article Long-Term Follow-Up Results of Anterior Cervical Inter-Body Fusion with Stand-Alone Cages Woong-Beom Kim, M.D., Seung-Jae Hyun, M.D., Ph.D., Hoyong Choi, M.D., Ki-Jeong Kim, M.D., Tae-Ahn Jahng, M.D., Hyun-Jib Kim, M.D. Department of Neurosurgery, Spine Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea Objective : The purpose of this study was to evaluate long-term follow-up radiologic/clinical outcomes of patients who underwent anterior cervical discectomy and inter-body fusion (ACDF) with stand-alone cages (SAC) in a single academic institution. Methods : Total 99 patients who underwent ACDF with SAC between February 2004 and December 2012 were evaluated retrospectively. A total of 131 segments were enrolled in this study. Basic demographic information, radiographic [segmental subsidence rate, fusion rate, C2–7 global angle, and segmental angle changes)/clinical outcomes (by Odom’s criteria and visual analog score (VAS)] and complications were evaluated to determine the long-term outcomes. Results : The majority were males (55 vs. 44) with average age of 53.2. Mean follow-up period was 62.9 months. The segmental subsidence rate was 53.4% and fusion rate was 73.3%. In the subsidence group, anterior intervertebral height (AIH) had more tendency of subsiding than middle or posterior intervertebral height (p=0.01). The segmental angle led kyphotic change related to the subsidence of the AIH. Adjacent segmental disease was occurred in 18 (18.2%) patients. Total 6 (6%) reoperations were performed at the index level. There was no statistical significance between clinical and radiological outcomes. But, overall long-term clinical outcome by Odom’s criteria was unsatisfactory (64.64%). The neck and arm VAS score were increased by over time. Conclusion : Long-term outcomes of ACDF with SAC group were acceptable but not satisfactory. For optimal decision making, more additional com- parative long-term outcome data is needed between ACDF with SAC and ACDF with plating. Key Words : Anterior cervical discectomy and fusion · Stand-alone cage · Subsidence · Long-term outcomes · Intervertebral height · Odom’s criteria. we suggested that anterior plating may play a key role in the INTRODUCTION 2) support of anterior inter-body height . However, not a few stud- Anterior cervical discectomy and inter-body fusion (ACDF) ies have mentioned ACDF with SAC is a clinically/radiological- 11,16-18) with stand-alone cages (SAC) has been regarded as an accept- ly satisfactory procedure . However, there has been few able treatment option for symptomatic cervical degenerative long-term follow-up data about the ACDF with SAC. Further- disease. Not a few previous reports have described that ACDF more, most of recent published reports included two-year or 11) with SAC is satisfactory in terms of radiographic and clinical much lower follow-up period . 16-18) results . However, several investigators reported that the cage The purpose of this study was to evaluate the long-term follow- 13,14,24) subsidence and kyphotic angular change after the procedure . up radiographic and clinical outcomes of patients having ACDF Nevertheless, the subsidence rate and kyphotic segmental change with SAC in a single academic institution. was not significantly associated with clinical outcome in a short- 8,11) term follow-up series . MATERIALS AND METHODS About superior surgical outcomes among ACDF with SAC, ACDF with anterior plating or artificial disc are still controver- This study was approved by the institutional review board. Af- sial. We previously reported that ACDF with plating had better ter IRB approval, we retrospectively reviewed the records of all 13) radiologic outcome than stand-alone cage groups . In that study, patients treated with single-, two-, and three-level ACDF with SAC • : • : • : Received March 25, 2016 Revised March 25, 2016 Accepted May 6, 2016 • : Address for reprints Seung-Jae Hyun, M.D., Ph.D. Department of Neurosurgery, Spine Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82 Gumi-ro 173beon-gil, Seongnam 07061, Korea : : : Tel +82-31-787-7169, Fax +82-31-787-4097, E-mail hyunsj@snu.ac.kr • ( ) This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License http://creativecommons.org/licenses/by-nc/3.0 which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 385 J Korean Neurosurg Soc 59 | July 2016 from February 2004 to December 2012. Patients having cervical by follow-up magnetic resonance (MR) imaging and medical radiculopathy or myelopathy caused by cervical degenerative disc chart reviewing. disease and spondylosis who failed conservative management Subsidence was defined as a decrease of the total interverte- were included. The exclusion criteria included systemic infec- bral height (TIH) between the two adjacent vertebral bodies by tion, malignancy, C7/T1 involved disease, inability to measure comparing the lateral cervical radiographs. We compared the first the C2–7 angle because of a short neck, no clinical/radiographic postoperative, one-month, one-year, two-year standing radio- 21) follow-up data and less than 24 months follow-up period. Total graphs and the ultimate follow-up radiographs . The TIH was six spine surgeons performed the operations in those periods. measured by three portion; anterior, middle and posterior points Demographic information, radiological studies and clinical pre- of the upper end plate of the cranial vertebral body and the low- sentation were reviewed for each case before and after surgery. er end plate of the caudal vertebral bodies. More than 3 mm de- crease at any of the three points was considered to represent sig- 6,7) Surgical technique nificant subsidence (Fig. 1) . Smith and Robinson method was used for the approach to Fusion was defined as less than 2 mm change between the 19) the anterior cervical spine . Intervertebral disc, posterior lon- tips of the spinous processes of the treated level by the compar- gitudinal ligament and osteophyte were resected with endplate ing the flexion-extension lateral radiographs or definite bony preparation. In cases with radiculopathy, uncoforaminotomy bridge of the index level on a lateral plain radiograph or comput- 4) was utilized for the neural foraminal decompression. For deter- ed tomographic (CT) scan . The global cervical angle between mining the appropriate cage size, a trial cage was used. Poly- the C2 and C7 vertebrae was measured. The segmental angle ether-ether-ketone (PEEK) or carbon fiber cage filled with al- was defined as the angle between the upper end plate of the up- lograft or autograft cancellous bone obtained from the anterior per vertebral body and the lower end plate of the lower vertebral iliac crest were used for ACDF. The cage was located 1–2 mm body. Negative values of the segmental angle and the global cervi- 13,14) depth from the anterior margin of the vertebral body. Neck col- cal angle mean cervical lordosis . For clinical outcomes, Odom’s 25) lars were applied to the patients for 4–12 weeks after ACDF. criteria and visual analog scales (VAS) were used . We catego- rized Odom’s criteria as Excellent (1), Good (2), Fair (3), and Assessment of radiologic and clinical outcomes Poor (4). Then we reviewed all the medical records of the patients For radiologic outcomes, the cage subsidence, fusion rate, at the ultimate visit and the Odom’s criteria were filled out. Neck C2–7 global angle, and segmental angle were evaluated by the and arm VAS were checked pre- and postoperatively (annual plain radiographs. Adjacent segmental disease was investigated fashion), and the ultimate follow-up period of the index surgery. A B C D Fig. 1. A : Preoperative cervical spine lateral radiograph. B, C, and D : Postoperative cervical spine lateral radiograph show subsidence (B : Immediate postoperative standing radiograph, C : 1 month postoperative standing radiograph, D : Ultimate follow-up period radiograph). 386 Long-Term Outcome of ACDF with Stand-Alone Cages | WB Kim, et al. 131 segments were enrolled in this study. Surgical level was as Statistical analysis Pearson’s chi-square test was used for the baseline differences followed : 6 segments at C3/4, 25 segments at C4/5, 61 segments in nominal variables analysis. Student’s t-test and the Mann-Whit- at C5/6, and 39 segments at C6/7. Mean follow-up period was ney U test for parametric and nonparametric continuous vari- 62.9 (range, 28–135) months (Table 1). ables were used for the analysis of baseline characteristics be- Subsidence occurred in 70 (53.4%) segments and 57 (57.6%) tween the two groups, respectively. A repeated measure analysis patients at the ultimate follow-up period. Subsidence at anterior of variance (RM-ANOVA) of one between and one within mixed intervertebral height (AIH) was significant than middle interver- design was performed for radiologic and clinical outcomes be- tebral height (MIH) and posterior intervertebral height (PIH). Av- tween the subsidence (S-) and non-subsidence (NS-) groups, also erage 5.40 mm of subsidence of AIH was occurred at the ulti- fused (F-) and non-fused (NF-) groups. All data were analyzed mate follow-up and the subsidence was progressed over time using SPSS version 22 for Windows (SPSS Inc., Chicago, IL, USA). (p<0.001) in the S-group. However, the AIH change in the NS- group was only 1.33 mm and less progressed over time than the S-group (p<0.001). The MIH changes were 4.83 mm and pro- RESULTS gressed over time in the S-group, 1.07 mm and less progressed A total 367 patients underwent ACDF with SAC from Febru- over time in the NS-group at the ultimate follow-up period. The ary 2004 to December 2012. Finally, a total of 99 consecutive PIH subsidence was occurred less than AIH [incidence of 64.3% patients were included in this study. The majority were males (45 over 70 S-group)] with an average 3.93 mm change (p<0.001). (55 vs. 44) with average age of 53.2 (range, 23–81) years. The Comparing the TIH change in the S-group between 1 month post- number of ACDF with SAC at one-, two- and three-level was 68, operative and the ultimate follow-up data, 2.26 mm at AIH, 1.54 29, 2 patients, respectively. For each individual segment, a total mm at MIH, and 1.1 mm at PIH were observed (Table 2, Fig. 2). Table 1. Patient demographics with or without subsidence Baseline characteristics Subsidence (S-group) No subsidence (NS-group) p-value Number 70 61 Age 53.6±11.2 52.7±8.70 0.673 Gender (male : female) 36 : 21 19 : 23 0.058 BMD -1.25±1.50 -1.2±0.80 0.91 Level 0.28 C3/4 02 (2.9%) 04 (6.6%) C4/5 14 (20%) 11 (18%) C5/6 31 (44.3%) 30 (49.2%) C6/7 23 (32.9%) 16 (26.2%) Segmental angle, preoperative 0.92±4.99 0.78±3.67 0.97 TIH, preoperative 0.50 Anterior 34.07±3.20 34.45±3.10 Middle 32.86±3.14 33.26±2.85 Posterior 34.47±2.95 35.06±2.76 Global cervical angle, preoperative -12.05±10.5 -11.16±9.50 0.67 BMD : bone mineral density, TIH : total intervertebral height (mm) (mm) (mm) 39 37 38 34 33 S-group S-group S-group NS-group NS-group NS-group 29 29 31 Preop I-postop 1 month 1 yr 2 yr Ultimate Preop I-postop 1 month 1 yr 2 yr Ultimate Preop I-postop 1 month 1 yr 2 yr Ultimate AIH AIH AIH AIH F/U MIH MIH MIH MIH MIH F/U PIH PIH PIH PIH PIH F/U AIH A B C Fig. 2. A, B, and C : Preoperative, immediate standing postoperative, 1 month, 1 year, 2 year postoperative, and ultimate follow-up AIH, MIH, and PIH (anterior, middle, and posterior intervertebral height) change between S- and NS-group. S : subsidence, NS : non-subsidence, AIH : anterior interverte- bral height, MIH : middle intervertebral height, PIH : posterior intervertebral height. 387 J Korean Neurosurg Soc 59 | July 2016 The demographics and characteristics of both S- and NS- The fusion rate of ACDF with SAC at the ultimate follow-up groups are descripted in Table 1. There was no significant differ- was 73.3% by segmental analysis (96 out of 131 segments), and ence in age (p=0.673), gender (p=0.058), level of surgery (p= 70.7% by population (70 over total 99 patients). There was no 0.357) and bone mineral density (BMD) score (p=0.91) between statistical significance between fusion rate and subsidence rate S- and NS-groups. (p=0.158), and BMD score (p=0.058). Table 2. Radiologic and clinical outcomes after ACDF with SAC Postoperative outcomes Subsidence (S-group) No subsidence (NS-group) p-value VAS of neck pain Preoperative 5.93±3.67 6.23±3.05 <0.82 1 year 2.58±2.54 01.35±1.22 <0.80 2 year 3.92±2.73 02.91±2.70 <0.36 Ultimate follow-up 4.00±3.21 2.60±3.41 <0.30 VAS of arm pain < Preoperative 6.53±3.16 07.30±2.36 <0.47 1 year 2.89±2.76 02.06±1.95 <0.31 2 year 3.29±2.39 01.91±2.38 <0.17 Ultimate follow-up 4.57±3.50 03.20±3.19 <0.33 TIH, anterior (mm) <0.001 Immediate postop. 37.76±4.05 35.66±3.23 1 month 34.58±3.28 34.78±3.28 1 year 33.35±3.29 34.64±3.12 2 year 32.74±3.44 34.43±3.09 Ultimate follow-up 32.32±3.28 34.27±3.07 TIH, middle (mm) <0.001 Immediate postop. 36.52±3.76 34.19±3.17 1 month 33.20±2.73 33.43±2.84 1 year 32.52±2.90 33.32±2.96 2 year 32.20±2.90 33.24±3.08 Ultimate follow-up 31.66±3.04 33.14±3.07 TIH, posterior (mm) <0.001 Immediate postop. 37.47±3.42 35.38±3.06 1 month 34.62±2.81 34.76±2.68 1 year 34.54±2.85 34.64±2.98 2 year 34.36±2.93 34.41±3.05 Last follow-up 33.52±2.85 34.39±3.07 Cage height (mm) <0.85 5 10 (14.3%) 12 (19.7%) 6 42 (60%) 36 (59%) 7 13 (18.6%) 10 (16.4%) 8 04 (5.7%) 03 (4.9%) 9 01 (1.4%) 00 Segmental angle (°) <0.002 Immediate postop. -0.75±5.77 .-0.23±4.99 Ultimate follow-up 4.02±5.44 00.66±5.27 Global cervical angle (°) Immediate postop. -12.4±11.8 -12.7±9.60 <0.89 Ultimate follow-up -11.9±11.6 -12.7±11.2 <0.72 Fusion rate (%) Ultimate follow-up 69.05 78.33 <0.16 Radiating arm pain (%) Ultimate follow-up 54.30 39.30 <0.01 ACDF : anterior cervical discectomy and inter-body fusion, SAC : stand-alone cages, VAS : visual analog scales, TIH : total intervertebral height 388 Long-Term Outcome of ACDF with Stand-Alone Cages | WB Kim, et al. The kyphotic segmental angle change had statistical signifi- Fair+11 Poor)/99] had unsatisfactory clinical outcome. There cance between S- and NS-group (p=0.002). From -0.92 degree at was no statistical significance between fusion, subsidence and the immediate postoperatively to 4.03 degree at the ultimate fol- Odom’s criteria (p=0.813). The mean score of preoperative neck low-up was observed which was associated with the higher fre- and arm VAS were 6.89 and 6.07, 2.00 and 2.50 after 1 year the quency of AIH subsidence than the MIH or PIH change (Fig. 3). surgery, 3.48 and 2.68 after 2 year the surgery, 4.00 and 3.44 at However, the C2–7 global cervical angle had no statistical signif- the ultimate follow-up period (Fig. 4). Compared S- and NS- icance between the two groups (p=0.72). group with the neck and arm VAS, neck VAS at the ultimate Adjacent segmental disease was occurred in 18 (18.2%) patients. follow-up period was usually maintained but slightly aggravated Total 6 (6%) reoperations were performed due to following rea- than 1 year after surgery, and arm VAS was aggravated over sons : acute epidural hematoma formation (one patient), motor time in the both group (Fig. 5). Subsidence and fusion were not weakness aggravation (one patient) and neck or arm pain aggra- related to the neck or arm VAS (p>0.05) (Table 3). vations as late complications (four patients). By Odom’s criteria, 4 Excellent (1), 31 Good (2), 53 Fair (3), DISCUSSION and 11 Poor (4) patients’ answers were collected. Total average score of Odom’s criteria was 2.71. And 64.6% of patients [64 (53 This study revealed a radiologic and clinical long-term result with an over average 5-year follow-up data after ACDF with SAC (°) S-group Neck VAS NS-group Arm VAS Preop 1 month 1 year 2 year Ultimate FU Preop 1 year 2 year Ultimate FU -1 Fig. 3. The preoperative, 1 month, 1 year, and 2 year after surgery, and Fig. 5. The preoperative, 1 year, 2 year after surgery, and the ultimate ultimate follow-up segmental angle change between S- and NS-group. follow-up neck VAS vs. arm VAS change following over time in all ACDF Negative value means lordotic segmental angle. S : subsidence, NS : with SAC patients. VAS : visual analog scale, ACDF : Anterior cervical dis- non-subsidence. cectomy and inter-body fusion, SAC : stand-alone cages. 7 8 S-group S-group NS-group NS-group Preop 1 year 2 year Ultimate FU Preop 1 year 2 year Ultimate FU A B Fig. 4. A : The preoperative, 1 year, 2 year after surgery, and the ultimate follow-up neck VAS change between S- and NS-group. B : The preoperative, 1 year, 2 year after surgery, and the ultimate follow-up arm VAS change between S- and NS-group. S : subsidence, NS : non-subsidence, VAS : visual analog scale. 389 J Korean Neurosurg Soc 59 | July 2016 Table 3. Neck, arm VAS and subsidence, fusion at the ultimate follow-up period Neck VAS vs. Arm VAS S-group NS-group p-value F-group NF-group p-value Ultimate f/u Neck VAS 4.00±3.20 2.60±3.40 0.30 3.05±2.96 4.43±4.11 0.36 Ultimate f/u Arm VAS 4.57±3.50 3.20±3.19 0.33 3.72±3.32 4.83±3.71 0.49 S-group : subsidence group, NS-group : non-subsidence group, F-group : fused group, NF-group : non-fused group, f/u : follow-up, VAS : visual analog scale surgery. Up to date, there had been several reports that investi- VAS score meant different manner to previous reports showing gated about the outcomes of ACDF with SAC. However, most ACDF with SAC was suitable. Although we failed to find key fac- of the results were carried short or intermediate term data be- tors that affecting the inferior outcomes, it seems that ACDF low two-year of follow-up, or a few two-year follow-up data with with SAC surgery did not have superiority to the other ACDF small population. The main stream of the published data about techniques. Therefore, to treat patients of degenerative cervical results after ACDF with SAC included subsidence rate as below spine disease, various factors (age, general condition, surgical 30% to variable and fusion rate higher than 90% mostly without level, bone quality, segmental/global angle, with or without uncal significant clinical relationship, therefore, the researchers sug- resection) should be considered thoroughly for optimal care. gested that the outcome of the stand-alone cage procedure was The limitations of our study include its retrospective nature, 3,5,9-11,15-18,20,22,23) suitable . We previously reported one-year radio- the number of case limitations, the enrolled patients in this study logic and clinical outcomes of 3 different construct systems for were not randomized meaning biased data and the lack of com- single-level ACDF using SAC, iliac graft plus plate augmenta- paring control group or other ACDF procedure group. The op- tion, and cage plus plating. In that study, ACDF with SAC rep- erations were not performed by a single surgeon, and the de- resented higher subsidence rate (58.6%) and lower fusion rate tailed operation techniques like the extent of endplate preparation 13,14) (63.2%) . After following the previous patients in a long-term or the micro-damage impact to the anterior portion of the cer- fashion, it seemed to have inferior results in terms of subsidence vical vertebral body when the inter-body cages be tapped to be and fusion rate according to this study. 74.6% (53/71) of subsid- inserted to the intervertebral space were not standardized. De- ence occurred within the first 6 month after surgery, the other spite a long-term follow-up, the key factors were not identified 25.4% (18/71) subsidence segments occurred after 6 months. clearly for the unsatisfactory outcome of ACDF with SAC. Those However, the subsidence was progressed over time in the sub- are also a limitation of this study. In this circumstance, investi- sidence group even after postoperative one year but was not gations about other factors like, meta-analysis of environmental significantly progressed in the non-subsidence group. Several aspects or patients’ specific factors would be helpful for deter- reports described that the subsidence mostly occurred within mining the accurate outcome evaluation of ACDF surgery. one-year after surgery and then be stabled, meaning no more 12,13) progressed . However in this study, the subsidence was pro- CONCLUSION gressed over time slowly. 58.6% (41/70) of subsided segments were progressed over time continuously until the ultimate fol- Long-term outcomes of ACDF with SAC group were accept- low-up period. Moreover, the fusion rate of 73.3% meant the non- able but not satisfactory. 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Journal of Korean Neurosurgical Society – Pubmed Central

Published: Jul 8, 2016

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