Prospective, Randomized, Double-Blind Clinical Study Evaluating the Correlation of Clinical Outcomes and Cervical Sagittal Alignment

Neurosurgery ◽  
2011 ◽  
Vol 68 (5) ◽  
pp. 1309-1316 ◽  
Author(s):  
Alan T. Villavicencio ◽  
Jason M. Babuska ◽  
Alex Ashton ◽  
Eric Busch ◽  
Cassandra Roeca ◽  
...  

Abstract BACKGROUND: Sagittal alignment of the cervical spine has received increased attention in the literature as an important determinant of clinical outcomes after anterior cervical diskectomy and fusion. Surgeons use parallel or lordotically fashioned grafts depending on preference or simple availability. OBJECTIVE: To quantitatively assess and compare cervical sagittal alignment and clinical outcome when lordotic or parallel allografts were used for fusion. METHODS: A prospective, randomized, double-blind clinical study that enrolled 122 patients was performed. The mean follow-up was 37.5 months (range, 12-54 months). RESULTS: The mean postoperative cervical sagittal alignment was 19° (range, −7°-36°) and 18° (range, −7°-37°) in the lordotic and parallel graft patient groups, respectively. The mean segmental sagittal alignment was 6° (range, −4°-19°) and 7° (range, −3°-19°) in the lordotic and parallel graft patient groups, respectively. There were no statistically significant differences in clinical outcome scores between the lordotic and parallel graft patient groups. However, patients who had maintained or improved segmental sagittal alignment, regardless of graft type, achieved a higher degree of improvement in Short Form-36 Physical Component Summary and Neck Disability Index scores. This was statistically significant (P < .038). CONCLUSION: The use of lordotically shaped allografts does not increase cervical/segmental sagittal alignment or improve clinical outcomes. Maintaining a consistent segmental sagittal alignment or increasing segmental lordosis was related to a higher degree of improvement in clinical outcomes.

2016 ◽  
Vol 24 (1) ◽  
pp. 100-107 ◽  
Author(s):  
Chang Kyu Lee ◽  
Dong Ah Shin ◽  
Seong Yi ◽  
Keung Nyun Kim ◽  
Hyun Chul Shin ◽  
...  

OBJECT The goal of this study was to determine the relationship between cervical spine sagittal alignment and clinical outcomes after cervical laminoplasty in patients with ossification of the posterior longitudinal ligament (OPLL). METHODS Fifty consecutive patients who underwent a cervical laminoplasty for OPLL between January 2012 and January 2013 and who were followed up for at least 1 year were analyzed in this study. Standing plain radiographs of the cervical spine, CT (midsagittal view), and MRI (T2-weighted sagittal view) were obtained (anteroposterior, lateral, flexion, and extension) pre- and postoperatively. Cervical spine alignment was assessed with the following 3 parameters: the C2–7 Cobb angle, C2–7 sagittal vertical axis (SVA), and T-1 slope minus C2–7 Cobb angle. The change in cervical sagittal alignment was defined as the difference between the post- and preoperative C2–7 Cobb angles, C2–7 SVAs, and T-1 slope minus C2–7 Cobb angles. Outcome assessments (visual analog scale [VAS], Oswestry Neck Disability Index [NDI], 36-Item Short-Form Health Survey [SF-36], and Japanese Orthopaedic Association [JOA] scores) were obtained in all patients pre- and postoperatively. RESULTS The average patient age was 56.3 years (range 38–72 years). There were 34 male patients and 16 female patients. Cervical laminoplasty for OPLL helped alleviate radiculomyelopathy. Compared with the preoperative scores, improvement was seen in postoperative VAS and JOA scores. After laminoplasty, 35 patients had kyphotic changes, and 15 had lordotic changes. However, cervical sagittal alignment after laminoplasty was not significantly associated with clinical outcomes in terms of postoperative improvement of the JOA score (C2–7 Cobb angle: p = 0.633; C2–7 SVA: p = 0.817; T-1 slope minus C2–7 lordosis: p = 0.554), the SF-36 score (C2–7 Cobb angle: p = 0.554; C2–7 SVA: p = 0.793; T-1 slope minus C2–7 lordosis: p = 0.829), the VAS neck score (C2–7 Cobb angle: p = 0.263; C2–7 SVA: p = 0.716; T-1 slope minus C2–7 lordosis: p = 0.497), or the NDI score (C2–7 Cobb angle: p = 0.568; C2–7 SVA: p = 0.279; T-1 slope minus C2–7 lordosis: p = 0.966). Similarly, the change in cervical sagittal alignment was not related to the JOA (p = 0.604), SF-36 (p = 0.308), VAS neck (p = 0.832), or NDI (p = 0.608) scores. CONCLUSIONS Cervical laminoplasty for OPLL improved radiculomyelopathy. Cervical laminoplasty increased the probability of cervical kyphotic alignment. However, cervical sagittal alignment and clinical outcomes were not clearly related.


2009 ◽  
Vol 9 (10) ◽  
pp. 2S-3S
Author(s):  
Alan Villavicencio ◽  
Jason Babuska ◽  
Ewell Nelson ◽  
Alexander Mason ◽  
Eric Busch ◽  
...  

2013 ◽  
Vol 19 (1) ◽  
pp. 90-94 ◽  
Author(s):  
Hironobu Sakaura ◽  
Tomoya Yamashita ◽  
Toshitada Miwa ◽  
Kenji Ohzono ◽  
Tetsuo Ohwada

Object A systematic review concerning surgical management of lumbar degenerative spondylolisthesis (DS) showed that a satisfactory clinical outcome was significantly more likely with adjunctive spinal fusion than with decompression alone. However, the role of adjunctive fusion and the optimal type of fusion remain controversial. Therefore, operative management for multilevel DS raises more complicated issues. The purpose of this retrospective study was to elucidate clinical and radiological outcomes after 2-level PLIF for 2-level DS with the least bias in determination of operative procedure. Methods Since 2005, all patients surgically treated for lumbar DS at the authors' hospital have been treated using posterior lumbar interbody fusion (PLIF) with pedicle screws, irrespective of severity of slippage, patient age, or bone quality. The authors conducted a retrospective review of 20 consecutive cases involving patients who underwent 2-level PLIF for 2-level DS and had been followed up for 2 years or longer (2-level PLIF group). They also analyzed data from 92 consecutive cases involving patients who underwent single-level PLIF for single-level DS during the same time period and had been followed for at least 2 years (1-level PLIF group). This second group served as a control. Clinical status was assessed using the Japanese Orthopaedic Association (JOA) score. Fusion status and sagittal alignment of the lumbar spine were assessed by comparing serial plain radiographs. Surgery-related complications and the need for additional surgery were evaluated. Results The mean JOA score improved significantly from 12.8 points before surgery to 20.4 points at the latest follow-up in the 2-level PLIF group (mean recovery rate 51.8%), and from 14.2 points preoperatively to 22.5 points at the latest follow-up in the single-level PLIF group (mean recovery rate 55.3%). At the final follow-up, 95.0% of patients in the 2-level PLIF group and 96.7% of those in the 1-level PLIF group had achieved solid spinal fusion, and the mean sagittal alignment of the lumbar spine was more lordotic than before surgery in both groups. Early surgery-related complications, including transient neurological complications, occurred in 6 patients in the 2-level PLIF group (30.0%) and 11 patients in the 1-level PLIF group (12.0%). Symptomatic adjacent-segment disease was found in 4 patients in the 2-level PLIF group (20.0%) and 10 patients in the 1-level PLIF group (10.9%). Conclusions The clinical outcome of 2-level PLIF for 2-level lumbar DS was satisfactory, although surgery-related complications including symptomatic adjacent-segment disease were not negligible.


2007 ◽  
Vol 86 (9) ◽  
pp. 848-851 ◽  
Author(s):  
K. Shinada ◽  
M. Tagashira ◽  
H. Watanabe ◽  
P. Sopapornamorn ◽  
A. Kanayama ◽  
...  

Previous research has shown the inhibitory effects of hop bract polyphenols (HBP) on cariogenic streptococci in vitro, but their effects in humans have not been investigated. This double-blind, crossover clinical study tested the hypothesis that HBP delivered in a mouthrinse suppresses plaque regrowth in humans. Twenty-nine healthy male volunteers had all plaque removed, and refrained from all oral hygiene for 3 days, except for rinsing with a mouthrinse containing 0.1% HBP or a placebo. The results showed that the mean amount of plaque assessed by the Patient Hygiene Performance score after the volunteers used the HBP mouthrinse was significantly less than that after they used the placebo (p < 0.001). The number of mutans streptococci in the plaque samples after volunteers used the HBP mouthrinse was significantly lower than that after they used the placebo (p < 0.05). These findings suggested that HBP, delivered in a mouthrinse, successfully reduced dental plaque regrowth in humans.


2016 ◽  
Vol 21 (03) ◽  
pp. 339-344 ◽  
Author(s):  
Chul-Hyun Cho ◽  
Geon-Myeong Oh

Background: The objective of this study was to determine prognostic factors affecting the clinical outcome of septic arthritis of the shoulder. Methods: We retrospectively reviewed 34 shoulders from 32 patients, two of which had bilateral involvement. Arthroscopic (22 shoulders) or open surgery (12 shoulders) was performed by a single surgeon. The mean follow-up period was 32.4 ± 17.0 months. Clinical outcomes according to the University of California at Los Angeles (UCLA) score, American Shoulder and Elbow Surgeons (ASES) score, and Subjective Shoulder Value (SSV) were assessed at the final follow-up period. Various factors were included for statistical analysis. Results: The mean UCLA, ASES scores, and SSV were 28.9 ± 7.2, 81.3 ± 21.0, 79.7 ± 2.5%, respectively. Positive culture was observed in only 13 shoulders (38.2%) and the most common organism was Staphylococcus aureus (seven shoulders). Five shoulders (14.7%) required two or three operations. Age and comorbidity were negatively correlated with the UCLA, ASES score, and/or SSV (p < 0.05). There was no correlation between clinical outcome and various parameters, including gender, location of lesion, history of previous steroid injection, interval between onset of symptoms and surgical intervention, bacterial organisms, operative method, and presence of rotator cuff tear and reoperation (p > 0.05). Conclusions: Both arthroscopic and open surgery for septic shoulders showed satisfactory clinical outcomes. Old age and comorbidity were poor prognostic factors of clinical outcomes after treatment.


2017 ◽  
Vol 42 (2) ◽  
pp. E3 ◽  
Author(s):  
Hsuan-Kan Chang ◽  
Chih-Chang Chang ◽  
Tsung-Hsi Tu ◽  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
...  

OBJECTIVE Many reports have successfully demonstrated that cervical disc arthroplasty (CDA) can preserve range of motion after 1- or 2-level discectomy. However, few studies have addressed the extent of changes in segmental mobility after CDA or their clinical correlations. METHODS Data from consecutive patients who underwent 1-level CDA were retrospectively reviewed. Indications for surgery were medically intractable degenerative disc disease and spondylosis. Clinical outcomes, including visual analog scale (VAS)–measured neck and arm pain, Neck Disability Index (NDI), and Japanese Orthopaedic Association (JOA) scores, were analyzed. Radiographic outcomes, including C2–7 Cobb angle, the difference between pre- and postoperative C2–7 Cobb angle (ΔC2–7 Cobb angle), sagittal vertical axis (SVA), the difference between pre- and postoperative SVA (ΔSVA), segmental range of motion (ROM), and the difference between pre- and postoperative ROM (ΔROM), were assessed for their association with clinical outcomes. All patients underwent CT scanning, by which the presence and severity of heterotopic ossification (HO) were determined during the follow-up. RESULTS A total of 50 patients (mean age 45.6 ± 9.33 years) underwent a 1-level CDA (Prestige LP disc) and were followed up for a mean duration of 27.7 ± 8.76 months. All clinical outcomes, including VAS, NDI, and JOA scores, improved significantly after surgery. Preoperative and postoperative ROM values were similar (mean 9.5° vs 9.0°, p > 0.05) at each indexed level. The mean changes in segmental mobility (ΔROM) were −0.5° ± 6.13°. Patients with increased segmental mobility after surgery (ΔROM > 0°) had a lower incidence of HO and HO that was less severe (p = 0.048) than those whose ΔROM was < 0°. Segmental mobility (ROM) was significantly lower in patients with higher HO grade (p = 0.012), but it did not affect the clinical outcomes. The preoperative and postoperative C2–7 Cobb angles and SVA remained similar. The postoperative C2–7 Cobb angles, SVA, ΔC2–7 Cobb angles, and ΔSVA were not correlated to clinical outcomes after CDA. CONCLUSIONS Segmental mobility (as reflected by the mean ROM) and overall cervical alignment (i.e., mean SVA and C2–7 Cobb angle) had no significant impact on clinical outcomes after 1-level CDA. Patients with increased segmental mobility (ΔROM > 0°) had significantly less HO and similarly improved clinical outcomes than those with decreased segmental mobility (ΔROM < 0°).


2009 ◽  
Vol 11 (5) ◽  
pp. 529-537 ◽  
Author(s):  
Andre Tomasino ◽  
Harry Gebhard ◽  
Karishma Parikh ◽  
Christian Wess ◽  
Roger Härtl

Object The authors present the radiological and clinical outcome data obtained in patients who underwent single-level anterior cervical discectomy and fusion (ACDF) for cervical spondylosis and/or disc herniation; bioabsorbable plates were used for instrumentation. The use of metallic plates in ACDF has gained acceptance as a stabilizing part of the procedure to increase fusion rates, but when complications occur with these devices, the overall effectiveness of the procedure is compromised. As a possible solution, bioabsorbable implants for ACDF have been developed. This study investigates the feasibility and radiological and clinical outcomes of the bioabsorbable plates for ACDF. Methods The radiological and clinical outcomes of 30 patients were investigated retrospectively. All patients presented with cervical radiculopathy or myelopathy and underwent single-level ACDF in which a bioabsorbable anterior cervical plate and an allograft bone spacer were placed at a level between C-3 and C-7. Radiological outcome was assessed based on the fusion rate, subsidence, and Cobb angle of the surgical level. Clinical outcome was determined by using a visual analog scale, the Neck Disability Index, and the Odom criteria. Results There were no intraoperative complications, and no hardware failure was observed. No signs or symptoms of adverse tissue reaction caused by the implant were seen. Two reoperations were necessary due to postoperative blood collections. The overall complication rate was 16.7%. After 6 months, radiographic fusion was seen in 92.3% of patients. Subsidence at 11.3 ± 7.2 months was 3.1 ± 5.8 mm (an 8.2% change over the immediately postoperative results), and the change in the sagittal curvature was –2.7 ± 2.7°. The visual analog scale score for neck and arm pain and Neck Disability Index improved significantly after surgery (p < 0.001). Overall at 19.5 months postoperatively, 83% of the patients had favorable outcomes based on the Odom criteria. Conclusions Absorbable instrumentation provides better stability than the absence of a plate but graft subsidence and deformity rates may be higher than those associated with metal implants. There were no device-related complications, but adverse late effects cannot be excluded. The fusion rate and outcome are comparable to the results achieved with metallic plates. The authors were satisfied with the use of bioabsorbable plates as a reasonable alternative to metal, avoiding the need for lifelong metallic implants.


2021 ◽  
Author(s):  
Yilin Lu ◽  
Jian Zhu ◽  
Xi Luo ◽  
Kaiqiang Sun ◽  
Jingchuan Sun ◽  
...  

Abstract Background: Some have speculated that LSTV has an impact on lumbar curve. A retrospective study was conducted to evaluate S-line as predictor of clinical outcome for patients undergone transforaminal lumbar interbody fusion for lumbar spinal stenosis.Methods: 126 patients undergoing transforaminal lumbar interbody fusion were enrolled. S-line stands for the connecting line between the highest points of the iliac crests on both sides. The patients were divided into two groups according to the position of S-line, S-line (-) group included patients whose S-line were between L4 and L5, and S-line (+) group included patients whose S-line is above or below this range, which were divided into two subgroups. Their pre-operative imaging data about sagittal alignment were collected, including lumbar lordosis (LL), sacral slope (SS), pelvic incidence (PI) and pelvic tilt (PT). Clinical outcomes were measured using Japanese Orthopaedic Association (JOA) scores, the Oswestry disability index (ODI), visual analog scale (VAS) before the surgery and postoperatively. The correlation of S-line and clinical outcomes, as well as sagittal alignment and clinical outcomes, were analyzed.Results: LL, SS, PI, PT and PI minus(-) LL of S-line (-) group were (45.39°±12.68°), (30.27°±10.55°), (43.32°±12.22°), (13.05°±6.52°), (-2.07°±8.20°), respectively, and those parameters of S-line (+) group were (40.29±14.92), (35.70°±14.09°), (52.59°±17.07°), (16.89°±8.24°), (12.30°±9.98°), respectively. Significant difference were seen in the above parameters between S-line (-) and S-line (+) group. For S-line (-) and S-line (+) group, post-operative JOA score were (22.39±2.12), (20.26±2.46), post-operative VAS were (2.07±0.88), (3.14±1.47), the post-operative ODI were (8.36±3.28), (11.82±3.32), the improvement rate is (0.61±0.13), (0.55±0.15), Significant differences of those parameters are seen between S-line (-) group and S-line (+) group.Conclusion: S-line is a reliable predictor of clinical outcome for patients undergone transforaminal lumbar interbody fusion for lumbar spinal stenosis.


2021 ◽  
Vol 29 (3) ◽  
pp. 230949902110592
Author(s):  
Haruhiko Shimura ◽  
Akimoto Nimura ◽  
Koji Fujita ◽  
Hidetoshi Kaburagi

Background This retrospective study was conducted to assess the clinical outcome and complications between tension band wiring (TBW) with eyelet wire and locking plate fixation used for the treatment of displaced olecranon fractures. Methods A total of 58 patients (36 males and 22 females; mean age: 63 years) were reviewed between April 2014 and September 2020. TBW with Ring Pin (RP group) was applied in 24 patients, including 15 Mayo type ⅡA and 9 Mayo type ⅡB patients. Anatomical locking plate (ALP group) was used in 34 patients, including 22 Mayo type ⅡA and 12 Mayo type ⅡB patients. Clinical outcome was evaluated using the Mayo Elbow Performance Score (MEPS), and active range of motion of the elbow and forearm and postoperative complications were reviewed. Results General characteristic of the patients and the fracture type were similar in the two groups. The mean MEPS values were 96.5 ± 7.3 in the RP group and 94.9 ± 9.4 in the ALP group. The mean elbow flexion arc was 127°±11 in the RP group. The mean elbow flexion arc was 122°±18 in the ALP group. No significant differences in clinical outcomes were observed between the two groups. Complication rates were significantly higher in the ALP group (19/34: 56%) than in the RP group (6/24: 25%). Conclusion Although there were no statistically significant differences in clinical outcomes between the two groups, the ALP group had a higher proportion of any complication than the RP group.


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