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Francois Porchet and Newton H. Metcalf

Object

A prospective, randomized clinical trial was conducted to compare the Prestige II Cervical Disc with anterior decompression and fusion for the treatment of single-level degenerative disease. Standardized clinical outcome measures and radiographic examinations were used at prescribed postoperative intervals to compare the treatment groups.

Methods

Patients with symptomatic single-level cervical disc disease who met the inclusion/exclusion criteria defined in the protocol were randomized to receive the Prestige II disc or iliac crest autograft fusion. All patients underwent a standardized neurological and radiographic examination and completed outcomes questionnaires (Neck Disability Index and Short Form–36) preoperatively and at each postoperative interval (6 weeks and 3, 6, 12, and 24 months). Two independent radiologists reviewed all x-ray films and assessed motion at the treated level and adjacent segments. Standard statistical methods were used to compare all outcome measures.

Preliminary results in 55 patients enrolled in the study are presented. Several patients have reached the final (24-month) follow-up interval. Clinical and radiographic results are encouraging, with significant improvement seen in both treatment groups. Radiographic results show that the Prestige II disc maintains motion at the treated level without adjacent-segment compromise.

Conclusions

Cervical spine arthroplasty is an exciting and rapidly developing surgical treatment option. An objective comparison with fusion is important to advance this option. This is the first prospective randomized trial in which cervical arthroplasty is compared with fusion. The preliminary results from this limited number of patients indicate that the Prestige II disc is potentially a viable alternative to fusion for primary cervical disc disease; however, further clinical studies with larger sample sizes will be required to show statistical equivalence.

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François Porchet, Anne Chollet-Bornand and Nicolas de Tribolet

Object. This study was undertaken to evaluate the long-term benefit in 202 patients who were surgically treated via a microsurgical far-lateral approach for foraminal or extraforaminal lumbar disc herniations.

Methods. All patients underwent surgery at the authors' institute since 1987 and represented 6.5% of all lumbar spinal disc surgeries. There were 67 women and 135 men who ranged in age from 19 to 78 years (mean age 58 years). All patients had unilateral leg pain due to lumbar disc herniations into or lateral to the lateral interpedicular compartment. One patient underwent surgery at the L1–2 level, nine at L2–3, 48 at L3–4, 86 at L4–5, and 58 at the L5—S1 level. The mean follow-up period was 50 months (range 12–120 months). Outcome was defined as excellent (no pain), good (some back pain), fair (moderate radiculopathy), and poor (unchanged or worse) based on Macnab classification. Overall, excellent and good results were achieved in 62 (31%) and 85 (42%) patients, respectively, and fair and poor results in 40 (20%) and 15 (7%) patients, respectively. Of 11 recurrent disc herniations, four presented in an extreme-lateral position, five in a paramedian location, and two on the contralateral side. There were three minor complications related to surgery, seven general complications, and no case of spinal instability.

Conclusions. The far-lateral approach is a safe, effective procedure that avoids the risk of secondary spinal instability.

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David Bellut, Jan-Karl Burkhardt, Anne F. Mannion and François Porchet

OBJECT

The aim of this study was to evaluate outcome in patients undergoing surgical treatment for intradural spinal tumor using a patient-oriented, self-rated, outcome instrument and a physician-based disease-specific instrument.

METHODS

Prospectively collected data from 63 patients with intradural spinal tumor were analyzed in relation to scores on the multidimensional patient-rated Core Outcome Measures Index (COMI) and the physician-rated modified McCormick Scale, before and at 3 and 12 months after surgery.

RESULTS

There was no statistically significant difference between the scores on the modified McCormick Scale preoperatively and at the 3-month follow-up, though there was a trend for improvement (p = 0.073); however, comparisons between the scores determined preoperatively and at the 12-month follow-up, as well as 3- versus 12-month follow-ups, showed a statistically significant improvement in each case (p < 0.004). The COMI scores for axial pain, peripheral pain, and back-related function showed a significant reduction (p < 0.001) from before surgery to 3 months after surgery, and thereafter showed no further change (p > 0.05) up to 12 months postoperatively. In contrast, the overall COMI score, “worst pain,” quality of life, and social disability not only showed a significant reduction from before surgery to 3 months after surgery (p < 0.001), but also a further significant reduction up to 12 months postoperatively (p < 0.001). The scores for work disability showed no significant improvement from before surgery to the 3-month follow-up (p > 0.05), but did show a significant improvement (p = 0.011) from 3 months to 12 months after surgery. At the 3- and 12-month follow-ups, 85.2% and 83.9% of patients, respectively, declared that the surgical procedure had helped/helped a lot; 95.1% and 95.2%, respectively, declared that they were satisfied/very satisfied with their care.

CONCLUSIONS

COMI is a feasible tool to use in the evaluation of baseline symptoms and outcome in patients undergoing surgery for intradural spinal tumor. COMI was able to detect changes in outcome at 3 months after surgery (before changes were apparent on the modified McCormick Scale) and on later postoperative follow-up. The COMI subdomains are valuable for monitoring the patient’s reintegration into society and the work environment. The addition of an item that specifically covers neurological deficits may further increase the value of COMI in patients with spinal tumors.

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Jan-Karl Burkhardt, Anne F. Mannion, Serge Marbacher, Patrick A. Dolp, Tamas F. Fekete, Dezsö Jeszenszky and François Porchet

Object

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.

Methods

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).

Results

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).

Conclusions

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.

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François Porchet, Friederike Lattig, Dieter Grob, Frank S. Kleinstueck, Dezsö Jeszenszky, Christophe Paus, David O'Riordan and Anne F. Mannion

Object

The contemporary assessment of spine surgical outcome primarily relies on patient-centered reports of symptoms and function. Such measures are considered to reduce bias compared with traditional surgeon-based outcome ratings. This study examined the agreement between patients' and surgeons' ratings of outcome 1 year after spine surgery.

Methods

The study involved 404 patients (mean age 56.6 ± 16.4 years; 259 women, 145 men) and their treating surgeons. At baseline and 12 months postoperatively patients completed the Core Outcome Measures Index (COMI) rating pain, function, quality of life, and disability. At 12 months postoperatively, they also rated the global outcome of surgery and their satisfaction with treatment. The surgeon, blinded to the patient's evaluation, rated the global outcome of surgery as excellent, good, fair, or poor.

Results

Seventy-six percent of the patients who were considered by the surgeon to have an excellent or good outcome achieved the minimum clinically important difference (MCID) of a 2.2-point reduction on the COMI; 24% achieved less than the MCID. There was a significant correlation between the surgeons' and patients' global outcome ratings (Spearman ρ = 0.56; p < 0.0001). The degree of absolute agreement between them was significantly influenced by surgeon seniority: senior surgeons “overrated” the outcome in 24.5% of cases (compared with patients' ratings) and “underrated” it in 17.5% of cases. Junior surgeons overrated in 7.8% of cases and underrated in 43.8% of cases (p < 0.0001). Surgeon overrating occurred significantly more frequently for patients with a poor self-rated outcome (measured as global outcome, COMI score, or satisfaction with treatment). In a multivariate model, the independent variables “senior surgeon” and “patient dissatisfaction with care” were the most significant unique predictors of surgeon overrating of the global outcome (p < 0.0001; adjusted R2 for the model = 0.16).

Conclusions

Overall, agreement between surgeon and patient was reasonably good. The majority of patients who were rated as excellent/good by the surgeons had achieved the MCID in the prospectively measured COMI score. Discrepancies in outcome ratings were influenced by surgeon seniority and patient satisfaction. For a balanced view of the surgical result, outcomes should be assessed from the perspectives of both the patient and the surgeon.

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Nils H. Ulrich, Jakob M. Burgstaller, Isaac Gravestock, Giuseppe Pichierri, Maria M. Wertli, Johann Steurer, Mazda Farshad and François Porchet

OBJECTIVE

In this retrospective analysis of a prospective multicenter cohort study, the authors assessed which surgical approach, 1) the unilateral laminotomy with bilateral spinal canal decompression (ULBD; also called “over the top”) or 2) the standard open bilateral decompression (SOBD), achieves better clinical outcomes in the long-term follow-up. The optimal surgical approach (ULBD vs SOBD) to treat lumbar spinal stenosis remains controversial.

METHODS

The main outcomes of this study were changes in a spinal stenosis measure (SSM) symptoms score, SSM function score, and quality of life (sum score of the 3-level version of the EQ-5D tool [EQ-5D-3L]) over time. These outcome parameters were measured at baseline and at 12-, 24-, and 36-month follow-ups. To obtain an unbiased result on the effect of ULBD compared to SOBD the authors used matching techniques relying on propensity scores. The latter were calculated based on a logistic regression model including relevant confounders. Additional outcomes of interest were raw changes in main outcomes and in the Roland and Morris Disability Questionnaire from baseline to 12, 24, and 36 months.

RESULTS

For this study, 277 patients met the inclusion criteria. One hundred forty-nine patients were treated by ULBD, and 128 were treated by SOBD. After propensity score matching, 128 patients were left in each group. In the matched cohort, the mean (95% CI) estimated differences between ULBD and SOBD for change in SSM symptoms score from baseline to 12 months were −0.04 (−0.25 to 0.17), to 24 months −0.07 (−0.29 to 0.15), and to 36 months −0.04 (−0.28 to 0.21). For change in SSM function score, the estimated differences from baseline to 12 months were 0.06 (−0.08 to 0.21), to 24 months 0.08 (−0.07 to 0.22), and to 36 months 0.01 (−0.16 to 0.17). Differences in changes between groups in EQ-5D-3L sum scores were estimated to be −0.32 (−4.04 to 3.40), −0.89 (−4.76 to 2.98), and −2.71 (−7.16 to 1.74) from baseline to 12, 24, and 36 months, respectively. None of the group differences between ULBD and SOBD were statistically significant.

CONCLUSIONS

Both surgical techniques, ULBD and SOBD, may provide effective treatment options for DLSS patients. The authors further determined that the patient outcome results for the technically more challenging ULBD seem not to be superior to those for the SOBD even after 3 years of follow-up.

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Ulrike Held, Johann Steurer, Giuseppe Pichierri, Maria M. Wertli, Mazda Farshad, Florian Brunner, Roman Guggenberger, François Porchet, Tamás F. Fekete, Urs D. Schmid, Isaac Gravestock and Jakob M. Burgstaller

OBJECTIVE

The aim of this study was to obtain an unbiased causal treatment estimate of the between-group difference of surgery versus nonoperative treatment with respect to outcomes on quality of life, pain, and disability in patients with degenerative lumbar spinal stenosis (DLSS) 12 months after baseline.

METHODS

The authors included DLSS patients from a large prospective multicenter observational cohort study. Propensity score matching was used, including 15 demographic, clinical, and MRI variables. Linear and logistic mixed-effects regression models were applied to quantify the between-group treatment effect. Unmeasured confounding was addressed in a sensitivity analysis, assessing the robustness of the results.

RESULTS

A total of 408 patients were included in this study, 222 patients after matching, with 111 in each treatment group. Patients with nonoperative treatment had lower quality of life at the 12-month follow-up (−6.21 points, 95% CI −9.93 to −2.49) as well as lower chances of reaching a minimal clinically important difference in Spinal Stenosis Measure (SSM) symptoms (OR 0.26, 95% CI 0.13 to 0.53) and SSM function (OR 0.26, 95% CI 0.14 to 0.49), than patients undergoing surgery. These results were very robust in case of unmeasured confounding. The surgical complication rate was low; 5 (4.5%) patients experienced a durotomy during intervention, and 5 (4.5%) patients underwent re-decompression.

CONCLUSIONS

The authors used propensity score matching to assess the difference in treatment efficacy of surgery compared with nonoperative treatment in elderly patients with DLSS. This study delivers strong evidence that surgical treatment is superior to nonoperative treatment. It helps in clinical decision-making, especially when patients suffer for a long time, sometimes over many years, hoping for a spontaneous improvement of their symptoms. In light of these new results, the number of years with disability can hopefully be reduced by providing adequate treatment at the right time for this ever-growing elderly and frail population.