Multidimensional Core Outcome Measures Index Research Articles

Anterior Lumbar Interbody Fusion in Elderly Patients: Peri- and Postoperative Complications and Clinical Outcome.

Anterior lumbar interbody fusion (ALIF) is an effective surgical technique for treating various lumbar pathologies, but its use in elderly patients is controversial. Data concerning complications and effectiveness are sparse. We investigated peri- and postoperative complications, radiographic parameters, and clinical outcome in elderly patients. Patients ≥65 years who underwent ALIF between January 2008 and August 2020 were included in the study. All surgeries were performed through a retroperitoneal approach. Clinical and surgical data as well as radiologic parameters were collected prospectively and analyzed retrospectively. A total of 39 patients were included; the mean age was 72.6 (±6.3) years (range: 65-90 years); and the mean American Society of Anesthesiologists (ASA) risk classification was 2.3 (±0.6). A laceration of the left common iliac vein was the only major complication recorded (2.6%). Minor complications occurred in 20.5% of patients. Fusion rate was 90.9%. Reoperation rate at the index level was 12.8 and 7.7% in adjacent segments. The multidimensional Core Outcome Measures Index (COMI) improved from 7.4 (±1.4) to 3.9 (±2.7) after 1 year and to 3.3 (±2.6) after 2 years. Oswestry disability index (ODI) improved from 41.2 (±13.7) to 20.9 (±14.9) after 1 year and to 21.5 (±18.8) after 2 years. Improvements of at least the minimal clinically important change score of 2.2 and 12.9 points in the ODI and COMI after 2 years were noted in 75 and 56.3% of the patients, respectively. With careful patient selection, ALIF is safe and effective in elderly patients.

Patient-rated outcome after atlantoaxial (C1-C2) fusion: more than a decade of evaluation of 2-year outcomes in 126 patients.

Various surgical techniques have been introduced for atlantoaxial (C1-C2) fusion, the most common being Magerl's (transarticular) or the Harms/Goel screw fixation. Common indications include degenerative osteoarthritis (OA), trauma or rheumatoid arthritis (RA). Only few, small studies have evaluated patient-reported outcomes after C1-C2 fusion. We investigated 2-year outcomes in a large series of consecutive patients undergoing isolated C1-C2 fusion. We analysed prospectively collected data (2005-2016) from our Spine outcomes database, collected within the framework of EUROSPINE's Spine Tango Registry. It included 126patients (34 (27%) men, 92 (73%) women; mean (SD) age 67 ± 19 y) who had undergone first-time isolated C1-C2 fusion (61% Magerl, 39% Harms(-Goel)) at least 2 years ago for OA (83 (66%)), RA (20 (16%)), fracture (15 (12%)) or other (8 (6%)). Patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10) and various single item outcomes. Questionnaires were returned by 118/126 (94%) patients, 2 years post-operative. Mean COMI scores showed a significant reduction from baseline: 6.9 ± 2.4 to 2.7 ± 2.5 (p < 0.0001). Overall, 75% patients achieved the MCIC of ≥ 2.2points reduction in COMI and 88% reported a good global outcome. 91% patients were satisfied/very satisfied with their care. Self-reported complications were declared by 16% patients and further surgery at the same segment, by 2.5%. In this large series with almost complete follow-up, C1-C2 fusion showed extremely good results. Despite the complexity of the intervention, outcomes surpassed those typically reported for simple procedures such as ACDF and lumbar discectomy, suggesting reservations about the procedure should perhaps be reviewed.

Association between the appropriateness of surgery, according to appropriate use criteria, and patient-rated outcomes after surgery for lumbar degenerative spondylolisthesis.

Treatment failures in spine surgery are often attributable to poor patient selection and the application of inappropriate treatment. We used published appropriate use criteria (AUC) to evaluate the appropriateness of surgery in a large group of patients operated for lumbar degenerative spondylolisthesis (LDS) and to evaluate its association with outcome. This was a retrospective analysis of prospectively collected outcome data from patients operated in our Spine Centre, 2005-2012. Appropriateness of surgery was judged based on the AUC. Patients had completed the multidimensional Core Outcome Measures Index (COMI) before surgery and at 3 months' and 1, 2 and 5years' follow-up (FU). In total, 448 patients (69.8 ± 9.6years; 323 (72%) women) were eligible for inclusion and the AUC could be applied in 393 (88%) of these. Surgery was considered appropriate (A) in 234 (59%) of the patients, uncertain/equivocal (U) in 90 (23%) and inappropriate (I) in 69 (18%). A/U patients had significantly (p < 0.05) greater improvements in COMI than I patients at each FU time point. The minimal clinically important change (MCIC) score for COMI was reached by 82% A, 76% U and 54% I patients at 1-year FU (p < 0.001, I vs A and U); the odds of achieving MCIC were 3-4 times greater in A/U patients than in I patients. The results suggest a relationship between appropriateness of surgery for LDS and the improvements in COMI score after surgery. The findings require confirmation in prospective studies that also include a control group of non-operated patients.

Surgical training in spine surgery: safety and patient-rated outcome.

The aim of this study was to investigate the difference in patient-reported outcomes and surgical complication rates between lumbar procedures carried out either by experienced board-certified spine surgeons (BCS) or by supervised spine surgery residents (RES) in a large Swiss teaching hospital. This was a single-center retrospective analysis of data collected prospectively within the framework of the EUROSPINE Spine Tango Registry. It involved the data of 1415 patients undergoing first-time surgery in our institution between the years 2004 and 2016. Patients were divided into three groups based on the surgical procedure: lumbar single-level fusion (SLF), single-level decompression (SLD) for lumbar spinal stenosis and disc hernia procedures (DH). Patient-reported outcome measures (primary outcome) included the multidimensional Core Outcome Measures Index (COMI) preoperatively and 3 and 12months postoperatively plus single items concerning satisfaction with care and global treatment outcome (GTO). Secondary outcomes included surgical variables such as blood loss, duration of surgery, complication rates and length of stay. There were no significant differences between the RES and BCS patient groups for most of the demographic and baseline clinical variables with the exception of age in the SLD group (p = 0.012), BMI in the DH group (p = 0.02) and leg pain in the SLF group (p = 0.03). COMI scores improved significantly after all three types of procedure (p < 0.0001) without significant difference (p > 0.05) between the patients of RES and BCS. There was no significant difference (p > 0.05) between RES and BCS patients with regard to satisfaction and GTO. There were no significant differences between RES and BCS (p > 0.05) in the surgical or medical complication rates. In the given setting, surgical training of spine surgery residents under guided supervision by board-certified spine surgeons was shown to be safe, as it was not associated with greater morbidity or mortality. Furthermore, it had no detrimental influence on patient-reported outcomes. The findings can be used to give reassurance to prospective patients that are to be operated on by supervised spine surgery residents. These slides can be retrieved under Electronic Supplementary Material.

Outcome of L5 radiculopathy after reduction and instrumented transforaminal lumbar interbody fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring.

To evaluate the incidence and course of iatrogenic L5 radiculopathy after reduction and instrumented fusion of high-grade L5-S1 isthmic spondylolisthesis and the role of intraoperative neurophysiological monitoring (IONM). Consecutive patients treated for high-grade spondylolisthesis with IONM from 2005 to 2013 were screened for eligibility. Prospectively collected clinical and surgical data as well as radiographic outcomes were analyzed retrospectively. Patients completed the multidimensional Core Outcome Measures Index (COMI) before and at 3, 12, and 24months after surgery. Seventeen patients were included, with a mean age of 26.3 (±9.5) years. Mean preoperative L5-S1 slip was 72% (±21%) and was reduced to 19% (±13%) postoperatively. Mean loss of reduction at last follow-up [mean 19months (±14, range 3-48months)] was 3% (±4.3%). Rate of new L5 radiculopathy with motor deficit (L5MD) after surgery was 29% (five patients). Four patients fully recovered after 3months, one patient was lost to neurologic follow-up. IONM sensitivity and specificity for postoperative L5MD was 20 and 100%, respectively. COMI, back pain and leg pain scores showed significant (p<0.001) improvements at 3months postoperatively, which were retained up to 24months postoperatively. Transient L5 radiculopathy after reduction and instrumented fusion of high-grade spondylolisthesis is frequent. With IONM the risk of irreversible L5 radiculopathy is minimal. If IONM signal changes recover, full clinical recovery is expected within 3months. Overall, patient-reported outcome of reduction and instrumented fusion of high-grade spondylolisthesis showed clinically important improvement.

Patient-Rated Outcomes of Lumbar Fusion in Patients With Degenerative Disease of the Lumbar Spine: Does Age Matter?

Single-center retrospective study of prospectively collected data, nested within the Eurospine Spine Tango data acquisition system. The aim of this study was to assess the patient-rated outcome and complication rates associated with lumbar fusion procedures in three different age groups. There is a general reluctance to consider spinal fusion procedures in elderly patients due to the increased likelihood of complications. Before and at 3, 12, and 24 months after surgery, patients completed the multidimensional Core Outcome Measures Index. At the 3-, 12-, and 24-month follow-ups, they also rated the Global Treatment Outcome and their satisfaction with care. Patients were divided into three age groups: younger (≥50 years <65 years; n = 317), older (≥65 years <80 years; n = 350), and geriatric (≥80 years; n = 40). A total of 707 consecutive patients were included. The preoperative comorbidity status differed significantly (P < 0.0001) between the age groups, with the highest scores in the geriatric group. Medical complications during surgery were lower in the younger age group (7%) than in the older (13.4%; P = 0.006) and geriatric groups (17.5%; P = 0.007); surgical complications tended to be higher in the elderly group (younger, 6.3%; older, 6.0%; geriatric, 15.0%; P = 0.09). There were no significant group differences (P > 0.05) for the scores on any of the Core Outcome Measures Index domains, Global Treatment Outcome, or patient-rated satisfaction at either 3-, 12-, and 24-months of follow-up. Despite greater comorbidity and complication rates in geriatric patients, the patient-rated outcome was as good in the elderly as it was in younger age groups up to 2 years after surgery. These data indicate that geriatric age needs careful consideration of associated risks but is not per se a contraindication for fusion for lumbar degenerative disease. 4.

Influence of previous surgery on patient-rated outcome after surgery for degenerative disorders of the lumbar spine.

Few studies have used multivariate models to quantify the effect of multiple previous spine surgeries on patient-oriented outcome after spine surgery. This study sought to quantify the effect of prior spine surgery on 12-month postoperative outcomes in patients undergoing surgery for different degenerative disorders of the lumbar spine. The study included 4940 patients with lumbar degenerative disease documented in the Spine Tango Registry of EUROSPINE, the Spine Society of Europe, from 2004 to 2015. Preoperatively and 12months postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10 scale). Patients' medical history and surgical details were recorded using the Spine Tango Surgery 2006 and 2011 forms. Multiple linear regression models were used to investigate the relationship between the number of previous surgeries and the 12-month postoperative COMI score, controlling for the baseline COMI score and other potential confounders. In the adjusted model including all cases, the 12-month COMI score showed a 0.37-point worse value [95% confidence intervals (95% CI) 0.29-0.45; p<0.001] for each additional prior spine surgery. In the subgroup of patients with lumbar disc herniation, the corresponding effect was 0.52 points (95% CI 0.27-0.77; p<0.001) and in lumbar degenerative spondylolisthesis, 0.40 points (95% CI 0.17-0.64; p=0.001). We were able to demonstrate a clear "dose-response" effect for previous surgery: the greater the number of prior spine surgeries, the systematically worse the outcome at 12months' follow-up. The results of this study can be used when considering or consenting a patient for further surgery, to better inform the patient of the likely outcome and to set realistic expectations.

The Prognosis of L5 Radiculopathy after Reduction and Instrumented Fusion of Adult Isthmic High-Grade Lumbosacral Spondylolisthesis and the Role of Multimodal Intraoperative Neuromonitoring

Objective: Iatrogenic L5 nerve root injury is a common complication of reduction of isthmic high-grade spondylolisthesis (HGS). However, the clinical presentation and prognosis as well as its impact on patient-rated outcome have never been analyzed systematically and the role of multimodal intraoperative neuromonitoring (MIOM) is largely unknown. Methods: Clinical and radiographic data from consecutive patients who underwent reduction and instrumented fusion of HGS between 2005 and 2013 in a single center were analyzed. The multidimensional Core Outcome Measures Index (COMI) was completed before and after surgery. MIOM with transcranial MEP and continuous EMG of index muscles were performed. Results: A total of 17 patients (13 females, 4 males) with a mean radiographic follow-up of 19 (range 3–48) months were included. Mean ( ± SD) age was 26.5 ( ± 9.2) years. The mean L5-S1 slip was 72% ( ± 21%), which was reduced to 19% ( ± 13%). After 1 year, COMI improved from 6.7 ± 1.7 to 3.7 ± 3.1, leg pain from 5.2 ± 3.1 to 2.3 ± 3, and back pain from 6.2 ± 1.9 to 3.4 ± 2.6. In five patients (29%), an incomplete L5 motor deficit occurred: two with ⅗ paresis or worse, and three with ⅘. Four of these patients fully recovered after 3 months, and one (5.9%) was lost to follow-up (FU). In 15 out of 17 procedures, 25 intraoperative MIOM alerts were recorded. Based on intraoperative recovery of the signals, MIOM predicted 1 new neurological deficit and 16 patients without deficits. The patient with the MIOM true positive deficit was the one lost to FU. Related to the long-term outcome of patients with FU, MIOM has a sensitivity and specificity of 100%. However, in predicting the early postoperative and mostly transient L5 motor deficits (occurring in 5/17 [29%]), the sensitivity was only 20%. Conclusions: Reduction and instrumented fusion of HGS showed a satisfactory outcome. The rate of transient L5 palsy was relatively high. However, the prognosis for this deficit is favorable and full recovery can be expected after 3 months in most cases. MIOM alerts occurred in 88% of the procedures and thereby possibly limited the prevalence of neurological deficits to 5.9%. Intraoperative recovery of deteriorating MIOM signals cannot predict transient neurological deficits.

Influence of gender on patient-oriented outcomes in spine surgery.

Few studies have examined gender differences in patient-oriented health-related quality of life before and after spine surgery. This study examined the influence of gender on baseline status and 1-year postoperative outcomes in a large series of patients undergoing surgery for different degenerative spinal disorders. The study included 1518 patients [812 men and 706 women; mean (SD) age 61.4 ± 16.2 years], with three different pathologies (disc herniation, degenerative spondylolisthesis, or spinal stenosis), treated with specified surgical approaches. Preoperatively and 12 months postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI). Medical history, surgical details and perioperative complications were documented with the Eurospine "Spine Tango" Surgery 2006 form. Preoperatively and for all three pathologies, women had significantly (p < 0.05) worse COMI-scores than men, especially for the sub-domains "leg/buttock pain", "dominant pain intensity", and "general quality of life"; the change in the COMI sum score 12 months postoperatively showed no significant gender differences for any pathology (p > 0.05). 71.3 % males and 72.9 % females achieved the minimal clinically important change score (MCIC; 2.2 point reduction) for the COMI. Controlling for potential cofounders (preoperative COMI, ASA, complications, pathology), gender showed no significant association with the failure to achieve MCIC. This results show that women do not differ significantly from men regarding their postoperative outcome, even though they present with a worse preoperative status. The management of a patient's condition should not differ depending on their gender, since both men and women are able to improve to a similar extent.

Lumbar Facet Joint Effusion on MRI as a Sign of Unstable Degenerative Spondylolisthesis

Retrospective study. To examine whether the outcomes of decompression alone (D) or decompression with fusion (D&F) differed depending on the presence or absence of the facet effusion sign in degenerative spondylolisthesis. There is ongoing discussion as to whether D&F is superior to D in the surgical treatment of patients with lumbar degenerative spondylolisthesis (LDS) and symptoms of spinal or radicular claudication. Previous studies have shown that a positive facet joint effusion sign on magnetic resonance imaging correlates with the spontaneous reduction of slip when comparing upright and supine postures and might represent a sign of instability, guiding treatment decisions. One hundred sixty patients [age 69 (SD 10) y; 119 women, 41 men] with a diagnosis of LDS were identified retrospectively from our Spine Center Registry (linked to the Eurospine, Spine Society of Europe Spine Tango Registry). They were categorized based on the presence/absence of the facet effusion sign and the type of treatment received. Forty-four patients had effusion and underwent D; 76 effusion and D&F; 19 no effusion and D; and 21 no effusion and D&F. Before surgery and 3, 12, and 24 months after surgery, patients completed the multidimensional Core Outcome Measures Index questionnaire. At follow-up, they rated the global treatment outcomes (1-5 scale). Multiple regression analyses evaluated the factors influencing the outcomes. When age and sex was controlled for, there was no significant difference in outcomes dependent on the presence of the facet effusion sign and/or the treatment received (D vs. D&F). Although mindful of the limitations of this retrospective study, we conclude that the effusion sign alone does not seem to be an indication for adding fusion to decompression in the treatment of LDS. Hence, the presence of the facet effusion sign should not, in itself, deter the surgeon from performing decompression alone. However, the phenomenon should be investigated in larger samples of patients, ideally within a randomized trial.

Adult degenerative scoliosis: comparison of patient-rated outcome after three different surgical treatments.

Few studies have examined the effectiveness of surgical treatment for adult degenerative scoliosis (ADS) using validated patient-orientated outcome instruments. This study reports patient outcomes in a large, consecutive series of patients being treated for ADS by simple decompression (D), short fusion (SF), or long fusion (LF). Our local spine surgery database (part of the Eurospine Spine Tango Registry) was used to acquire the data from patients with ADS undergoing D, SF or LF. Preoperatively and at 12 and 24months follow-up (FU), patients completed the multidimensional Core Outcome Measures Index (COMI; 0-10); at FU, satisfaction and global outcome were rated on a five-point Likert scale and dichotomised as "good" and "poor", and patient-rated complications were recorded. 173 patients took part (81 D, 53 SF, 39 LF). Compared with the two fusion groups, the D group was significantly older, had more comorbidity, and had more leg pain than back pain (each p<0.05). There were significant differences among the groups for operation duration, blood loss and general complications (each p<0.05), in each case with the LF group showing the greatest values and the D group the lowest values. However, patient-rated complications were not significantly different between the groups (p>0.89). Further surgery within the 2-year follow-up was required in 7% of the D group, 15% in SF and 28% in LF. All groups benefited significantly from surgery with no significant differences (p>0.05) between them: improvement in COMI after 24months was 2.9±2.8 points for D, 3.1±3.3 points for SF and 3.2±3.1 points for LF; a "good global outcome" was recorded for 69, 74 and 76% patients, respectively. Despite the complexity of the disease, patient-orientated outcomes after surgery for ADS were similar to those previously reported using the same outcome instruments in patients with lumbar stenosis and degenerative spondylolisthesis. The use of D, SF and LF for ADS yielded similarly good results from the patient's perspective. This most likely reflects careful and appropriate patient selection. Further analyses are warranted to identify baseline variables predicting the 26-31% cases in each group with a poor outcome.

The influence of cervical plate fixation with either autologous bone or cage insertion on radiographic and patient-rated outcomes after two-level anterior cervical discectomy and fusion.

We aimed to identify technique-related factors influencing radiographic and patient-rated outcomes after two-level anterior cervical discectomy with fusion (ACDF) using either cage or autologous bone, with or without anterior plate fixation (APF). This single center study was nested within the Eurospine Spine Tango data acquisition system. consecutive two-level ACDF patients (2004-2012) presenting with signs of degenerative cervical radiculopathy or myelopathy. Before and 12 month postoperatively, patients completed the multidimensional Core Outcome Measures Index (COMI); at 12 months postoperatively they also rated the global treatment outcome (GTO) and their satisfaction with care. Cervical lordosis and segmental height were assessed radiographically preoperatively, immediately postoperatively, and at the last follow-up (LFU) (18.2 ± 13.3 months). One hundred and forty-four consecutive patients (113 with APF) were included. The use of APF versus stand-alone methods was associated with significantly increased segmental height (by 2.6 ± 2.6 versus 1.5 ± 2.4 mm, p = 0.04) and preservation of lordosis (by 2.7 ± 4.4° versus -1.7 ± 5°, p < 0.0001) at LFU, with comparable clinical outcome (COMI score reduction ≥3.1-point). Multiple regression controlling for potential confounders revealed that APF (p = 0.0004) and cage (p = 0.001) were associated with greater segmental height at LFU; APF was associated with a greater lordosis angle at LFU (p < 0.0001). Greater increase in segmental height at LFU (p = 0.02) was associated with a better GTO. Adding APF was associated with greater segmental height and preservation of lordosis in two-level ACDF, especially using bone autograft, but also for cage. Clinical outcome was comparable for all groups. Though the surgical technique per se did not determine clinical outcome, patients achieving a greater segmental height difference showed a significantly better GTO.

Patient-rated Outcomes of Lumbar Fusion in Patients with Degenerative Disease of the Lumbar Spine: Does Age Matter?

Introduction: Current demographic changes are characterized by population aging, such that the surgical treatment of degenerative spine conditions in the elderly is gaining increasing relevance. However, there is a general reluctance to consider spinal fusion procedures in this patient age group due to the increased likelihood of complications. The aim of this study was to assess the patient-rated outcome and complication rates associated with lumbar fusion procedures in three different age groups. Methods: This was a retrospective analysis of prospectively collected data from consecutive patients who underwent first-time, one to three level posterior instrumented fusion between 2004 and 2011, due to degenerative disease of the lumbar spine. Data were obtained from our Spine Surgery Outcomes Database (linked to the International Spine Tango Register). Before surgery, patients completed the multidimensional Core Outcome Measures Index (COMI), and at 3 and 12 months after surgery they completed the COMI and rated the Global Treatment Outcome (GTO) and their satisfaction with care. Patients were divided into three groups according to their age: younger (≥50y <65y; n = 317), older (≥65y <80y; n = 350), and geriatric (≥ 80y; n = 40). Results: 707 consecutive patients were included. The preoperative comorbidity status differed significantly (p 0.05) for any of the COMI domains covering pain, function, symptom specific well-being, general quality of life, and social and work disability at either 3 months’ or 12 months’ follow-up. Similarly, there were no differences (p>0.05) between the age groups for GTO and patient-rated satisfaction at either follow-up. Conclusions: Preoperative comorbidity and general medical complications during lumbar fusion for degenerative disorders of the lumbar spine are both greater in geriatric patients than in younger patients. However, patient-rated outcome is as good in the elderly as it is in younger age groups. These data suggest that geriatric age per se is not a contraindication to instrumented fusion for lumbar degenerative disease.

The influence of comorbidity on the risks and benefits of spine surgery for degenerative lumbar disorders

The ageing of the population will see a growing number of patients presenting for spine surgery with appropriate indications but numerous medical comorbidities. This complicates decision-making, requiring that the likely benefit of surgery (outcome) be carefully weighed up against the potential risk (complications). We assessed the influence of comorbidity on the risks and benefits of spine surgery. 3,549/4,053 patients with degenerative lumbar disorders, undergoing surgery with the goal of pain relief, completed the multidimensional Core Outcome Measures Index (COMI; scored 0-10) before and 12 months after surgery. At 12 months postoperatively, they also rated the global treatment outcome and their satisfaction with care. Using the Eurospine Spine Tango Registry, surgeons documented surgical details, American Society of Anesthesiologists comorbidity (ASA) grades and perioperative surgical and general complications. 29.0% patients were rated as ASA1 (normal healthy), 45.7% as ASA2 (mild/moderate systemic disease), 24.9% as ASA3 (severe), and just 0.4% as ASA4 (life-threatening). In going from ASA1 to ASA3 (ASA4 group too small), surgical complications increased significantly from 5.0 to 14.5% and general complications increased from 2.9 to 15.7%; 12-month outcomes showed a corresponding decline, with a good global outcome being reported by 79% ASA1 patients, 76% ASA2, and 68% ASA3. Satisfaction with treatment was 87, 85, and 79%, respectively, and reduction in COMI was 4.2 ± 2.9, 3.7 ± 3.0, and 3.4 ± 3.0 points, respectively. Multiple regression analysis revealed a significant (p < 0.0001) independent effect of ASA grade on both complications and outcome. The negative impact of comorbidity on the outcome of spine surgery has not been well investigated/quantified to date. The ASA grade may be helpful in producing algorithms for decision-making and preoperative counselling regarding the corresponding risks and benefits of surgery.

A comparative effectiveness study of patient-rated and radiographic outcome after 2 types of decompression with fusion for spondylotic myelopathy: anterior cervical discectomy versus corpectomy

Both anterior cervical discectomy with fusion (ACDF) and anterior cervical corpectomy with fusion (ACCF) are used to treat cervical spondylotic myelopathy; however, there is currently no evidence for the superiority of one over the other in terms of patient-rated outcomes. This comparative effectiveness study compared the patient-rated and radiographic outcomes of 2-level ACDF versus 1-level ACCF. This single-center study was nested within the EuroSpine Spine Tango data acquisition system. Inclusion criteria were the following: consecutive patients presenting with signs of cervical spondylotic myelopathy who underwent 2-level ACDF or 1-level ACCF between 2004 and 2011. Before and 12 months after surgery, patients completed the multidimensional Core Outcome Measures Index (COMI) and also rated global treatment outcome and satisfaction with care on 5-point Likert scales. Cervical lordosis, segmental height, and fusion rate were assessed radiographically before and immediately after surgery and at the last follow-up (20.4 ± 13.7 months, mean ± SD). In total, 118 consecutive patients (80 in the ACDF group and 38 in the ACCF group) were included. Age, sex, comorbidity, baseline symptoms, baseline radiographic data, operation duration, and complication rates did not differ significantly between the 2 groups. Blood loss was significantly (p < 0.04) lower in the ACDF group. Postoperative mean segmental height was significantly (p = 0.0006) greater for ACDF (42.0 ± 4.2 mm, mean ± SD) than for ACCF (39.0 ± 4.0 mm), and global average lordosis improved to a significantly (p = 0.003) greater extent in ACDF (by 1.6° ± 4.1°) than in ACCF (by -1.0° ± 4.0°). Fusion rates for ACDF were 97.5% and for ACCF were 94.7% (p = 0.59). The 12-month patient-rated outcomes did not differ significantly between ACDF and ACCF: 82.4% and 68.6% had a good global outcome (operation helped/helped a lot) (p = 0.10), 86.5% and 82.9% were satisfied/very satisfied with care (p = 0.62), and the reduction in the multidimensional COMI was 2.8 ± 2.7 and 2.2 ± 3 points (p = 0.30), respectively. The postoperative increase in lordosis angle showed low but significant correlations with the improvement in arm pain (r = 0.25, p = 0.014), highest pain (r = 0.25, p = 0.013), and function (r = 0.24, p = 0.016). Both ACDF and ACCF are safe and effective in the treatment of cervical spondylotic myelopathy, indicated by similarly good patient-rated outcomes 1 year after surgery. This precludes any conclusions regarding the superiority of one technique over the other, although it should be noted that ACDF resulted in less blood loss and greater improvements in cervical lordosis and segmental height than ACCF. Patients with improved lordosis angle had a better clinical outcome.

The bothersomeness of patient self-rated “complications” reported 1 year after spine surgery

The last few decades have witnessed a paradigm shift in the assessment of outcome in spine surgery, with patient-centred questionnaires superseding traditional surgeon-based assessments. The assessment of complications after surgery and their impact on the patient has not enjoyed this same enlightened approach. This study sought to quantify the incidence and bothersomeness of patient-rated complications 1 year after surgery. Patients with lumbar degenerative disorders, operated with the goal of pain relief between October 2006 and September 2010, completed a questionnaire 1 year postoperatively enquiring about complications arising as a consequence of their operation. They rated the bothersomeness of any such complications on a 5-point scale. Global outcome of surgery and satisfaction at the 12-month follow-up were also rated on 5-point Likert scales. The multidimensional Core Outcome Measures Index (COMI) was completed preoperatively and at the 12-month follow-up. Of 2,282 patients completing the questionnaire (92% completion rate), 687 (30.1%) reported complications, most commonly sensory disturbances (36% of those with complications) or ongoing/new pain (26%), followed by motor problems (8%), pain plus neurological disturbances (11%), and problems with wound healing (6%). The corresponding "bothersomeness" ratings for these were: 1% not at all, 23% slightly, 27% moderately, 31% very, and 18% extremely bothersome. The greater the bothersomeness, the worse the global outcome (Rho = 0.51, p < 0.0001), patient satisfaction (Rho = 0.44, p < 0.0001) and change in COMI score (Rho = 0.52, p < 0.0001). Most complications reported by the patient are perceived to be at least moderately bothersome and hence are not inconsequential. Complications and their severity should be assessed from both the patient's and the surgeon's perspectives--not least to better understand the reasons for poor outcome and dissatisfaction with treatment.

To fuse or not to fuse in lumbar degenerative spondylolisthesis: do baseline symptoms help provide the answer?

Clinical symptoms in lumbar degenerative spondylolisthesis (LDS) vary from predominantly radiating pain to severe mechanical low back pain. We examined whether the outcome of surgery for LDS varied depending on the predominant baseline symptom and the treatment administered [decompression with fusion (D&F) or decompression alone (D)]. 213 consecutive patients (69 ± 9 years; 155f, 58 m) participated. Inclusion criteria were LDS, maximum three affected levels, no previous surgery at the affected level, and D (N = 56) or D&F (N = 157) as the operative procedure. Pre-op and at 12 months' follow-up (FU), patients completed the multidimensional Core Outcome Measures Index (COMI) including 0-10 leg-pain (LP) and LBP scales. At 12 months' FU, patients rated global outcome which was then dichotomised into "good" and "poor". Pre-operatively, LBP and COMI scores were significantly worse (p < 0.05) in the D&F group than in the D group. The improvement in COMI at 12 months' FU was significantly greater for D&F than for D (p < 0.001) and was not influenced by the patient's declared "main problem" at baseline (back pain, leg pain, or neurological disturbances) (p > 0.05). There was a higher proportion (p = 0.01) of "good" outcomes at 12 months' FU in D&F (86%) than in D (70%). Multiple regression analysis, controlling for possible confounders, revealed treatment group to be the only significant predictor of outcome (adding fusion = better outcome). Our study indicated that LDS patients showed better patient-based outcome with instrumented fusion and decompression than with decompression alone, regardless of baseline symptoms. This may be due to the fact that the underlying slippage as the cause of the stenosis is better addressed with fusion.

The outcome of decompression surgery for lumbar herniated disc is influenced by the level of concomitant preoperative low back pain

Decompression surgery is a common and generally successful treatment for lumbar disc herniation (LDH). However, clinical practice raises some concern that the presence of concomitant low back pain (LBP) may have a negative influence on the overall outcome of treatment. This prospective study sought to examine on how the relative severity of LBP influences the outcome of decompression surgery for LDH. The SSE Spine Tango System was used to acquire the data from 308 patients. Inclusion criteria were LDH, first-time surgery, maximum 1 affected level, and decompression as the only procedure. Before and 12 months after surgery, patients completed the multidimensional Core Outcome Measures Index (COMI; includes 0-10 leg/buttock pain (LP) and LBP scales); at 12 months, global outcome was rated on a Likert scale and dichotomised into "good" and "poor" groups. In the "good" outcome group, mean baseline LP was 2.8 (SD 3.1) points higher than LBP; in the "poor" group, the corresponding value was 1.1 (SD 2.9) (p < 0.001 between groups). Significantly fewer patients with back pain as their "main problem" had a good outcome (69% good) when compared with those who reported leg/buttock pain (84% good) as the main problem (p = 0.04). In multivariate regression analyses (controlling for age, gender, co-morbidity), baseline LBP intensity was a significant predictor of the 12-month COMI score, and of the global outcome (each p < 0.05) (higher LBP, worse outcome). In conclusion, patients with more back pain showed significantly worse outcomes after decompression surgery for LDH. This finding fits with general clinical experience, but has rarely been quantified in the many predictor studies conducted to date. Consideration of the severity of concomitant LBP in LDH may assist in establishing realistic patient expectations before the surgery.

An Observational Study of Patient-rated Outcome After Atlantoaxial Fusion in Patients With Rheumatoid Arthritis and Osteoarthritis

Fusion is used to address several types of abnormality of the atlantoaxial segment. Traditionally, outcome has been assessed by achieving solid bony union. Recently, however, patient-rated outcome instruments have been increasingly used, although these may be influenced by concomitant comorbidity. We therefore asked whether patients with rheumatoid arthritis (RA), with its associated comorbidity, had worse self-rated outcomes after C1-2 fusion than patients with osteoarthritis (OA). We retrospectively reviewed all 30 (23 OA and seven RA) prospectively followed patients in our local Spine Registry (part of the Spine Society of Europe Spine Tango Registry) who had undergone C1-2 fusion. Before surgery and 3 and 12months later, patients completed the multidimensional Core Outcome Measures Index (COMI) questionnaire. Global outcome and satisfaction with treatment were also assessed. We found no group differences for duration of operation, blood loss, or perioperative surgical or general complications. Compared with the OA group, the RA group showed a better baseline COMI score and less improvement in the COMI from preoperatively to 12months followup. However, the proportion of "good" global scores at 12months followup was similarly high in both groups (87% OA and 86% RA) as was satisfaction (96% for OA versus 86% for RA). Symptoms and impairment were less severe in the RA group at baseline and showed less improvement after surgery, but the proportion of "good global outcomes" was similar in both groups, and the great majority of patients in both groups were satisfied with their treatment. Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

Randomised controlled trials (RCTs) of cervical disc arthroplasty vs fusion generally show slightly more favourable results for arthroplasty. However, RCTs in surgery often have limited external validity, since they involve a select group of patients who fit very rigid admission criteria and who are prepared to subject themselves to randomisation. The aim of this study was to examine whether the findings of RCTs are verified by observational data recorded in our Spine Center in association with the Spine Society of Europe Spine Tango surgical registry. Patients undergoing fusion/stabilisation or disc arthroplasty for degenerative cervical spinal disease were selected for inclusion. They completed a questionnaire pre-operatively and at 12 and 24 months follow-up (FU). The questionnaire comprised the multidimensional Core Outcome Measures Index (COMI; 0-10 scale) and, at FU, questions on global outcome and satisfaction with treatment (5-point scales, dichotomised to "good" and "poor"), re-operation and patient-rated complications. The surgeon completed a Spine Tango Surgery form. The outcome data from 266 (208 fusion, 58 arthroplasty) out of 284 eligible patients who had reached 12 months FU, and 169 (139 fusion, 30 arthroplasty) out of 178 who had reached 24 months FU, were included. Patients with cervical disc arthroplasty were younger [46 (SD 8) years vs 56 (SD 11) years for fusion; P < 0.05], had less comorbidity (P < 0.05), more often had only mono-segmental pathology (69% arthroplasty, 47% fusion) and only one type of degenerative pathology (69% arthroplasty, 46% fusion). Surgical complication rates were similar in each group (arthroplasty, 1.5%; fusion, 2.6%). The reduction in the COMI score was significantly greater in the arthroplasty group (at 12 months, 4.8 (SD 3.0) vs 3.7 (SD 2.9) points for fusion, and at 24 months 5.1 (SD 2.8) vs 3.8 (SD 2.9) points; each P < 0.05). In the arthroplasty group, a "good" global outcome was recorded in 90% patients (at 12 months) and 93% (at 24 months); in the fusion group the figures were 80 and 82%, respectively (group differences at each timepoint, P > 0.09). Satisfaction with treatment was similar in both groups (89-93%), at each timepoint. In multiple regression analysis, treatment group was of borderline significance as a unique predictor of the change in COMI at FU (P = 0.059 at 12 months, P = 0.055 at 24 months) in a model in which known confounders (age, comorbidity, number of affected levels) were controlled for. Being in the arthroplasty group was associated with an approximately 1-point greater reduction in the COMI score at FU. The results of this observational study appear to support those of the RCTs and suggest that, in patients with degenerative pathology of the cervical spine, disc arthroplasty is associated with a slightly better outcome than fusion. However, given the small size of the difference, its clinical relevance is questionable, especially in view of the a priori more favourable outcome expected in the arthroplasty group due to the more rigorous selection of patients.