Clinical outcomes of locking stand-alone cage versus anterior plate construct in two-level anterior cervical discectomy and fusion: a systematic review and meta-analysis.

BACKGROUND: Two-level cervical degenerative disc disease (cDDD) can be effectively treated by anterior cervical discectomy and fusion (ACDF) similarly to single-level cDDD. Traditionally an anterior plate construct (APC) approach has been utilized, but ACDF without plate with a locking stand-alone cage (LSC) approach has emerged as an alternative option. The aim of this study was to compare the clinical outcome of LSC and APC in contiguous two-level ACDF used to treat cDDD the current literature. METHODS: Searches of seven electronic databases from inception to March 2018 were conducted following preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Extracted data were analysed using meta-analysis of proportions. RESULTS: The nine observational studies that satisfied all criteria described a pooled cohort of 687 contiguous two-level cDDD cases managed by ACDF, with 302 (44%) and 385 (56%) managed by LSC and APC approaches, respectively. When compared with APC, LSC was associated with significantly increased subsidence likelihood (OR 2.75; p < 0.001), greater disc height (MD 0.60 mm; p = 0.04) and reduced cervical lordosis (MD - 2.52°; p = 0.04) at last follow-up. Operative outcomes, fusion rates, functional scores and postoperative dysphagia rates were comparable. CONCLUSION: Although significant radiological differences were most evident, the comparability between LSC and APC in contiguous two-level ACDF with respect to all other clinical outcomes does not implicate one approach as clearly superior to the other in two-level ACDF. Larger, randomized studies with longer follow-up are required to delineate outcomes further to validate the findings of this study. These slides can be retrieved under Electronic Supplementary Material.

Evaluation of bony fusion after anterior cervical discectomy: a systematic literature review.

PURPOSE: Anterior cervical discectomy and fusion (ACDF) has proven effective in treating radicular arm pain. Post-operatively, cervical spine stability is temporarily challenged, but data on bony fusion and speed of fusion are ambiguous; optimum evaluation method and criteria are debated. AIM: To study bony fusion accomplishment and to obtain an overview of methods to evaluate fusion. METHODS: A literature search was performed in PubMed and Embase. Included studies had to report original data concerning 1- or 2-level ACDF with intervertebral device or bone graft, where bony fusion was assessed using CT scans or X-rays. RESULTS: A total of 146 articles comprising 10,208 patients were included. Bony fusion was generally defined as "the presence of trabecular bridging" and/or "the absence of motion". Fusion was accomplished in 90.1% of patients at the final follow-up. No gold standard for assessment could be derived from the results. Addition of plates and/or cages with screws resulted in slightly higher accomplishment of fusion, but differences were not clinically relevant. Eighteen studies correlated clinical outcome with bony fusion, and 3 found a significant correlation between accomplishment and better clinical outcome. CONCLUSIONS: In approximately 90% of patients, bony fusion is accomplished one year after ACDF. As there is no generally accepted definition of bony fusion, different measuring techniques cannot be compared to a gold standard and it is impossible to determine the most accurate method. Variations in study design hamper conclusions on optimising the rate of bony fusion by choice of material and/or additives. Insufficient attention is paid to correlation between bony fusion and clinical outcome. These slides can be retrieved from electronic supplementary material.

Evaluation of a center of excellence program for spine surgery.

BACKGROUND: The Centers for Medicare and Medicaid Services and many private health plans are encouraging patients to seek orthopedic care at hospitals designated as centers of excellence. No evaluations have been conducted to compare patient outcomes and costs at centers of excellence versus other hospitals. The objective of our study was to assess whether hospitals designated as spine surgery centers of excellence by a group of over 25 health plans provided higher quality care. METHODS: Claims representing approximately 54 million commercially insured individuals were used to identify individuals aged 18-64 years with 1 of 3 types of spine surgery in 2007-2009: 1-level or 2-level cervical fusion (referred to as cervical simple fusion), 1-level or 2-level lumbar fusion (referred to as lumbar simple fusion), or lumbar discectomy and/or decompression without fusion. The primary outcomes were any complication (7 complications were captured) and 30-day readmission. The multivariate models controlled for differences in age, sex, and comorbidities between the 2 sets of hospitals. RESULTS: A total of 29,295 cervical simple fusions, 27,214 lumbar simple fusions, and 28,911 lumbar discectomy/decompressions were identified, of which 42%, 42%, and 47%, respectively, were performed at a hospital designated as a spine surgery center of excellence. Designated hospitals had a larger number of beds and were more likely to be an academic center. Across the 3 types of spine surgery (cervical fusions, lumbar fusions, or lumbar discectomies/decompressions), there was no difference in the composite complication rate [OR 0.90 (95% CI, 0.72-1.12); OR 0.98 (95% CI, 0.85-1.13); OR 0.95 (95% CI, 0.82-1.07), respectively] or readmission rate [OR 1.03 (95% CI, 0.87-1.21); OR 1.01 (95% CI, 0.89-1.13); OR 0.91 (95%, CI 0.79-1.04), respectively] at designated hospitals compared with other hospitals. CONCLUSIONS: On average, spine surgery centers of excellence had similar complication rates and readmission rates compared with other hospitals. These results highlight the importance of empirical evaluations of centers of excellence programs.

An exploration of patients' expectation of and satisfaction with surgical outcome.

PURPOSE: The majority of studies of surgical outcome focus on measures of function and pain. Increasingly, however, the desire to include domains such as patients' satisfaction and expectations had led to the development of simple measures and their inclusion into clinical studies. The purpose of this study was to determine patients' pre-operative expectations of and post-operative satisfaction with the outcome of their spinal surgery. METHODS: As part of the FASTER randomised controlled trial, patients were asked pre-operatively to quantify their expected improvement in pain and health status at 6 weeks, 6 and 12 months following surgery using 100 mm visual analogue scales (VAS), and to indicate their confidence in achieving this result and also the importance of this recovery to them. Patients were then asked to rate their satisfaction with the improvement achieved at each post-operative review using 100 mm VAS. RESULTS: Although differences between patients' expectation and achievement were minimal 6 weeks post-operatively, there was a clear discrepancy at 6 months and 1 year, with patient expectations far exceeding achievement. There were significant correlations between failure to achieve expectations and the importance patients attached to this recovery at each post-operative assessment, but not with their confidence in achieving this result. Satisfaction levels remained high despite expectations not being met, with discectomy patients being more satisfied than decompression patients. CONCLUSIONS: Patients' pre-operative expectations of surgical outcome exceed their long-term achievement. The more importance the patient attached to a good outcome, the larger is the discrepancy between expectation and achievement. Despite this, satisfaction levels remained high. The impact of unrealistic expectations on outcome remains unclear.

Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial.

A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. Proponents have claimed that minimally invasive procedures reduce postoperative pain and accelerate the recovery. In addition, there exist only a limited number of well-designed comparison studies comparing standard microdiscotomy to a tubular minimally invasive technique that support this claim. Furthermore, there are no well-designed studies looking at the transferability of those results and possible learning curve phenomena. We studied 100 patients, who were planned for disc prolapse surgery at two centres [50 patients at the developing centre (index) and 50 patients at the less experienced (transfer) centre]. The randomisation was done separately for each centre, employing a block-randomisation procedure with respect to age and preoperative Oswestry score. Operation duration was chosen as a primary outcome parameter as there was a distinguished shortening observed in a preliminary study at the index centre enabling a sound case number estimation. The following data were compared between the two groups and the centres with a 12-month follow-up: surgical times (operation duration and approach duration), the clinical results, leg and back pain by visual analogue scale, the Oswestry disability index, length of hospital stay, return to work time, and complications. The operation duration was statistically identical for MC (57.8 +/- 20.2 min) at the index centre and for MAPN (50.3 +/- 18.3 min) and MC (54.7 +/- 18.1 min) at the transfer centre. The operation duration was only significantly shorter for the MAPN technique at the index centre with 33.3 min (SD 12.1 min). There was a huge clinical improvement for all patients regardless of centre or method revealed by a repeated measures ANOVA for all follow-up visits Separate post hoc ANOVAs for each centre revealed that there was a significant time-method (MAPN vs. MC) interaction at the index centre (F = 3.75, P = 0.006), whereas this crucial interaction was not present at the transfer centre (F = 0.5, P = 0.7). These results suggest a slightly faster clinical recovery for the MAPN patients only at the index centre. This was due to a greater reduction in VAS score for back pain at discharge, 8-week and 6-month follow up (P < 0.002). The Oswestry-disability scores reached a significant improvement compared to the initial values extending over the complete follow-up at both centres for both methods without revealing any differences for the two methods in either centre. There was no difference regarding complications. The results demonstrate that a shorter operation duration and concomitant quicker recovery is comprehensible at an experienced minimally invasively operating centre. These advantages could not be found at the transfer centre within 25 minimally invasive procedures. In conclusion both procedures show equal mid term clinical results and the same complication rate even if the suggested advantages for the minimally invasive procedure could not be confirmed for the transfer centre within the framework of this study.

Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial.

STUDY DESIGN: A prospective, randomized multicenter IDE trial between May 2002 and October 2004. OBJECTIVE: The aim of this study was to report on the 10-year safety and efficacy of BRYAN cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty (CDA) is a potential alternative for anterior cervical decompression and fusion (ACDF) with the hope that maintenance of motion may decrease the likelihood of adjacent segment disease. METHODS: This is an analysis of a US Food and Drug Administration (FDA) investigation comparing CDA with ACDF for single-level patients. Eligible patients were ≥ 21 years of age with symptomatic cervical disc disease who had failed conservative care. Patients were followed at regular intervals with the current data set at > 10 years. Protocol for overall success: ≥ 15-point improvement in NDI scores, maintenance or improvement in neurologic status, no serious adverse events related to implant or implant/surgical procedure, and no subsequent surgery or intervention classified as "failure." RESULTS: At 10-year follow-up, 128 (CDA) and 104 (ACDF) patients were available for evaluation. Overall success rate was significantly higher for CDA group (81.3% vs. 66.3%; P = 0.005). The rate of second surgeries at adjacent levels was lower for CDA group (9.7% vs. 15.8%; P = 0.146). NDI scores improved significantly in CDA group (Δ38.3 vs. Δ31.1; P = 0.010). Visual Analog Scale (VAS) neck and arm improved in the CDA group (Δ54.3 vs. Δ49.2; P = 0.119), (Δ58.1 vs. Δ51.6; P = 0.0.60) respectively. About 4.1% of CDA patients and 4.9% of ACDF patients had serious adverse events related to study device. Mean angular motions at index level for BRYAN disc and ACDF were 8.69° and 0.60°, respectively. CONCLUSION: CDA can preserve and maintain motion in the long term compared with ACDF. There was a trend toward fewer adjacent segment surgeries for BRYAN disc that did not reach significance. Significant improvement in CDA NDI scores may suggest better long-term success for CDA as compared to fusion. LEVEL OF EVIDENCE: 2.

Sporting activity following discectomy for lumbar disc herniation.

The aim of this study was to investigate to what extent patients could resume physical activity following surgery for herniated lumbar disks. We analyzed a cohort of 1003 patients who underwent lumbar spine surgery within 1 year. Out of this cohort, 93 patients were selected according to our inclusion criteria (age 20-35 years, mediolateral single level disk herniation, no comorbidity at the lumbar spine, and treatment with conventional subtotal diskectomy). This group was evaluated after a minimum follow-up of 28 months in a telephone questionnaire; participants were questioned about pre- and postoperative physical activities. The questionnaire was answered by 67 patients. Twenty-six patients were lost to follow-up because they had relocated. The follow-up group had a mean age of 30 years. Five patients underwent a second procedure due to recurrent disk herniation. All patients showed a pain reduction. At follow-up, no patient needed constant pain medication. Eighty-two percent of the patients were pain free during practicing sports. Sixty-two patients performed some type of sport after surgery. Concerning the type and frequency of physical activities, no significant change between pre- and postoperative behavior occurred. The 5 patients with recurrent disk herniation did not behave differently. Single-level lumbar disk surgery does not limit or compromise sportive activity in young people.

Sequestrectomy Versus Conventional Microdiscectomy for the Treatment of a Lumbar Disc Herniation: A Systematic Review.

STUDY DESIGN: A systematic review. OBJECTIVE: The aim of this study was to compare the effects of sequestrectomy versus conventional microdiscectomy for lumbar disc herniation (LDH). SUMMARY OF BACKGROUND DATA: Open surgery for LDH can be performed by sequestrectomy (removal of disc fragments) or conventional discectomy (removal of disc fragments and disc). Sequestrectomy might be associated with a higher risk of recurrence but less low back pain (LBP) after surgery. METHODS: We searched MEDLINE and EMBASE from 1980 to November 2014. We selected randomized controlled trials (RCTs) and nonrandomized prospective studies of conventional discectomy versus sequestrectomy for adult patients with LDH that evaluated the following primary outcomes: radicular pain or LBP as measured by a visual analog scale, or neurological deficits of the lower extremity. We also evaluated the following secondary outcomes: complications of surgery, reherniation rate, duration of hospital stay, postoperative analgesic use, and health-related quality-of-life measures. Two authors independently reviewed citations and articles for inclusion. We assessed the risk of bias, synthesized data, and the level evidence using standard methodological procedures as recommended by the Cochrane Back Review Group. RESULTS: We identified 5 studies (746 participants) of sequestrectomy versus microdiscectomy. One study was RCT and the other 4 were nonrandomized prospective comparisons; all studies were assessed as being at a high risk of bias. There were no significant differences for leg pain, LBP, functional outcomes, complications, and hospital stay or recurrence rate for 2 years (level of evidence: Low). Sequestrectomy was associated with less analgesic consumption versus discectomy (level of evidence: Very low). CONCLUSION: Sequestrectomy and standard microdiscectomy were associated with similar effects on pain after surgery, recurrence rate, functional outcome, and complications; more evidence is needed to determine whether sequestrectomy is associated with less postoperative analgesic consumption. LEVEL OF EVIDENCE: 2.

[Lumbosacral radicular syndrome: good chance for recovery even without MRI diagnosis and treatment]. / Het lumbosacrale radiculaire syndroom: ook zonder MRI-diagnostiek en behandeling grote kans op herstel.

Two men aged 32 and 39 years had had sciatica for one week and 12 weeks, respectively. In both MRI revealed a prolapsed disc. The first patient recovered spontaneously after 9 weeks, the other recovered after discectomy. After a clinical diagnosis of sciatica, the question arises when additional diagnostic procedures are called for. This question is closely related to the treatment of sciatica. Spontaneous recovery occurs in many patients with sciatica whereas non-invasive therapies including bed rest show a relative lack of effectiveness. While surgical intervention is an effective therapy, the high rate of surgical procedures for disc herniation in the Netherlands compared with most other industrialised countries calls for a critical appraisal of indications for surgery.

Rehabilitation after lumbar disc surgery: an update Cochrane review.

STUDY DESIGN: Cochrane systematic review of randomized controlled trials. OBJECTIVE: To evaluate the effects of active rehabilitation for adults after first-time lumbar disc surgery. SUMMARY OF BACKGROUND DATA: Several rehabilitation programs are available for individuals after lumbar disc surgery, however, little is known about the efficacy of these treatments. METHODS: Search strategies were performed on CENTRAL (The Cochrane Library 2007, Issue 2) and MEDLINE, EMBASE, CINAHL, and PsycINFO up to May 2007. All randomized controlled trials without language limitations were included. Pairs of review authors independently assessed studies for eligibility and risk of bias. A meta-analysis was performed with clinically homogeneous studies. The GRADE approach was used to determine the quality of evidence. RESULTS: Fourteen studies were included, 7 of which had a low risk of bias. Most programs were only assessed in 1 study. Statistical pooling was only completed for 3 comparisons in which exercises started 4 to 6 weeks postsurgery: exercise programs versus no treatment, high versus low intensity exercise programs, and supervised versus home exercises. We found low quality evidence (3 randomized controlled trials [RCTs], N = 122) that exercises are more effective than no treatment for pain at short-term follow-up (weighted mean difference [WMD]:-11.13; 95% CI: -18.44 to -3.82) and moderate evidence (2 RCTs, N = 102) that exercises are more effective for functional status on short-term follow-up (WMD: -6.50; 95% CI: -9.26 to -3.74). None of the studies reported that exercises increased the reoperation rate. We also found low quality evidence (2 RCTs, N = 103) that high intensity exercises are slightly more effective than low intensity exercise programs for pain in the short-term (WMD: -10.67; 95% CI: -17.04 to -4.30) and moderate evidence (2 RCTs, N = 103) that they are more effective for functional status in the short-term (standardized mean difference [SMD] -0.77; 95% CI: -1.17 to -0.36). Finally, we found low quality evidence (3 RCTs, N = 95) that there were no significant differences between supervised and home exercises for short-term pain relief (SMD: -1.12; 95% CI: -2.77-0.53) or functional status (3 RCT, N = 95; SMD -1.17; 95% CI: -2.63-0.28). CONCLUSION: Exercise programs starting 4 to 6 weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment. High intensity exercise programs seem to lead to a faster decrease in pain and disability than low intensity programs. There were no significant differences between supervised and home exercises for pain relief, disability, or global perceived effect. There is no evidence that active programs increase the reoperation rate after first-time lumbar surgery.

Rates of lumbar disc surgery before and after implementation of multidisciplinary nonsurgical spine clinics.

STUDY DESIGN: Correlation study. OBJECTIVES: To assess the rates of lumbar disc surgery in North Jutland County, Denmark, before and after implementation of two nonsurgical spine clinics, and to compare the observed rates with those for the rest of Denmark in the same time periods. SUMMARY OF BACKGROUND DATA: Few studies have addressed initiatives to reduce high rates of lumbar disc surgery by improving nonsurgical care offered to patients with sciatica and low back pain. METHODS: The study was conducted in North Jutland County, Denmark with 500,000 inhabitants (10% of the Danish population). In 1997, two nonsurgical spine clinics were established, along with an educational program for general practitioners. The clinics targeted patients with sciatica of 1 to 3 months' duration, with or without low back pain. Data on rates of lumbar disc surgery were obtained from the National Registry of Patients. RESULTS: The annual rate of lumbar disc operations for patients in North Jutland County decreased from approximately 60 to 80 per 100,000 before 1997 to 40 per 100,000 in 2001 (P = 0.00), and the rate of elective, first-time disc surgeries decreased by approximately two thirds (P = 0.00). In contrast, the annual rate of lumbar disc operations for patients in the rest of Denmark remained unchanged during the same period. CONCLUSIONS: The implementation of multidisciplinary, nonsurgical spine clinics coincided closely with a significant reduction in the rate of lumbar disc surgery. The observed reduction seems most likely to be causally associated with educational activities and improved patient care provided by the clinics.