Paul C. Willems

Contributors to Secondary Osteoporosis and Metabolic Bone Diseases in Patients Presenting with a Clinical Fracture

BACKGROUND Previously undetected contributors to secondary osteoporosis and metabolic bone diseases (SECOB) are frequently found in patients with osteoporosis, but the prevalence in patients at the time they present with a clinical fracture is unknown. METHODS All consecutive patients with a recent clinical vertebral or nonvertebral fracture, who were able and willing to be investigated (n = 626: 482 women, 144 men, age range 50-97 yr) had bone mineral density and laboratory investigations (serum calcium, inorganic phosphate, 25-hydroxyvitamin D, creatinine, intact PTH, TSH, free T(4), serum and urine protein electrophoresis, and in men also serum testosterone). RESULTS Known SECOB contributors were present in 23.0% of patients and newly diagnosed SECOB contributors in 26.5%: monoclonal proteinemia (14 of 626), renal insufficiency grade III or greater (54 of 626), primary (17 of 626) and secondary (64 of 626) hyperparathyroidism, hyperthyroidism (39 of 626), and hypogonadism in men (12 of 144). Newly diagnosed SECOBs, serum 25-hydroxyvitamin D less than 50 nmol/liter (in 63.9%), and dietary calcium intake less than 1200 mg/d (in 90.6%) were found at any age, in both sexes, after any fracture (except SECOB in men with finger and toe fractures) and at any level of bone mineral density. CONCLUSION At presentation with a fracture, 26.5% of patients have previously unknown contributors to SECOB, which are treatable or need follow-up, and more than 90% of patients have an inadequate vitamin D status and/or calcium intake. Systematic screening of patients with a recent fracture identifies those in whom potentially reversible contributors to SECOB and calcium and vitamin D deficiency are present.

Lumbar Discography: Should We Use Prophylactic Antibiotics?: A Study of 435 Consecutive Discograms and a Systematic Review of the Literature

Background: Lumbar discography can be used in the diagnostic work-up of degenerative spine disease. The most serious complication is discitis, believed to be due to penetration of the disc by a needle contaminated with skin flora. The use of prophylactic antibiotics has been advocated, although there is great concern regarding their efficacy and possible adverse effects on disc cells. Methods: In the current study, the incidence of postdiscography discitis without the use of prophylactic antibiotics was studied in a consecutive patient group. Additionally, a systematic literature review was performed using strict criteria: 1) Discography was performed by means of a two-needle technique, 2) complications such as discitis were specifically looked for at follow-up, and 3) the exact numbers of patients and those lost to follow-up were reported. Results: The clinical results of 200 patients with 100% follow-up for a minimum period of 3 months showed no case of discitis. In the literature review, 10 studies were selected. Nine studies without prophylactic antibiotics reported an overall incidence of 12 cases in 4891 patients (0.25%) or 12,770 discs (0.094%). The only study with prophylactic antibiotics (127 patients) showed no case of discitis. Conclusions: Regarding the small number of patients in the only study in which antibiotics were used and the overall low incidence of postdiscography discitis, not enough evidence was found that prophylactic antibiotics can prevent discitis. It was concluded that in lumbar discography by means of a two-needle technique without prophylactic antibiotics, the risk of postdiscography discitis is minimal and there is not enough support from the literature to justify the routine use of prophylactic antibiotics.

Fracture Liaison Service: Impact on Subsequent Nonvertebral Fracture Incidence and Mortality

BACKGROUND A fracture liaison service model of care is widely recommended and applied, but data on its effectiveness are scarce. Therefore, the risk of subsequent nonvertebral fractures and mortality within two years after a nonvertebral fracture was analyzed in patients who presented to a hospital with a fracture liaison service and a hospital without a fracture liaison service. METHODS In 2005 to 2006, all consecutive patients with an age of fifty years or older presenting with a nonvertebral fracture were included. In the group that presented to a hospital without a fracture liaison service (the no-FLS group), only standard fracture care procedures were followed to address proper fracture-healing. In the group that presented to a hospital with a fracture liaison service (the FLS group), dual x-ray absorptiometry scans and laboratory testing were performed, and if applicable, patients were treated according to the Dutch guideline for osteoporosis. The risk for subsequent nonvertebral fracture and mortality were analyzed using multivariable Cox regression models with adjustments for age, sex, and baseline fracture location. RESULTS In total, 1412 patients presented to the fracture liaison service (73.2% were women, and the mean age was 71.1 years), and 1910 underwent standard fracture care (69.8% were women, and the mean age was 69.5 years). After adjustment for age, sex, and baseline fracture location, patients who attended the fracture liaison service had a significantly lower mortality risk (hazard ratio: 0.65; 95% confidence interval [CI]: 0.53 to 0.79) over two years of follow-up. The subsequent nonvertebral fracture risk was also significantly lower in the patients in the FLS group, but this effect was time-dependent, with a hazard ratio of 0.84 (95% CI: 0.64 to 1.10) at twelve months and 0.44 (95% CI: 0.25 to 0.79) at twenty-four months. CONCLUSIONS Patients seen at the fracture liaison service had a significantly lower mortality and subsequently a lower risk of nonvertebral fracture than those not seen at the fracture liaison service, with a reduction of 35% and 56%, respectively, over two years of follow-up. A fracture liaison service appears to be a successful approach to reduce the number of subsequent fractures and premature mortality in this cohort of patients.

Periprosthetic tissue reactions observed at revision of total intervertebral disc arthroplasty

Wear, wear particle induced inflammation, and osteolysis following total disc arthroplasty were, until recently, not thought to be present due to limited intervertebral motion and the lack of a synovial membrane between the lower lumbar vertebrae. The purpose of this study was to evaluate the periprosthetic tissue reactions associated with total disc arthroplasty revision surgery. Periprosthetic samples of fibrous tissue were collected in all patients during revision surgery of SB Charité III disc prostheses. Revision was indicated for intractable pain after an average of 8 years. Histological evaluation was performed in tissue samples of 16 patients using light microscopy and polarized light microscopy with a magnification of 100x. Polyethylene particles were detected in 15 of 16 patients. The smallest particles were the most numerate. A positive correlation was present between the number of particles per mm(2) and the extent of the chronic inflammatory reaction in the periprosthetic fibrous tissue. Osteolysis was observed in one patient. In the tissue samples containing polyethylene particles, TNF-alpha and IL-6 were determined by immunohistochemistry. TNF-alpha and IL-6 were co-expressed as a subset of mononuclear macrophages and giant cells.

Systematic review of anterior interbody fusion techniques for single- and double-level cervical degenerative disc disease.

Study Design. A systematic review of randomized controlled trials. Objective. To determine which technique of anterior cervical interbody fusion (ACIF) gives the best outcome in patients with cervical degenerative disc disease. Summary of Background Data. The number of surgical techniques for decompression and ACIF as treatment for cervical degenerative disc disease has increased rapidly, but the rationale for the choice between different techniques remains unclear. Methods. From a comprehensive search, we selected randomized studies that compared anterior cervical decompression and ACIF techniques, in patients with chronic single- or double-level degenerative disc disease or disc herniation. Risk of bias was assessed using the criteria of the Cochrane back review group. Results. Thirty-three studies with 2267 patients were included. The major treatments were discectomy alone and addition of an ACIF procedure (graft, cement, cage, and plates). At best, there was very low-quality evidence of little or no difference in pain relief between the techniques. We found moderate quality evidence for few secondary outcomes. Odoms criteria were not different between iliac crest autograft and a metal cage (risk ratio [RR]: 1.11; 95% confidence interval [CI]: 0.99–1.24). Bone graft produced more fusion than discectomy (RR: 0.22; 95% CI: 0.17–0.48). Complication rates were not different between discectomy and iliac crest autograft (RR: 1.56; 95% CI: 0.71–3.43). Low-quality evidence was found that iliac crest autograft results in better fusion than a cage (RR: 1.87; 95% CI: 1.10–3.17); but more complications (RR: 0.33; 95% CI: 0.12–0.92). Conclusion. When fusion of the motion segment is considered to be the working mechanism for pain relief and functional improvement, iliac crest autograft appears to be the golden standard. When ignoring fusion rates and looking at complication rates, a cage as a golden standard has a weak evidence base over iliac crest autograft, but not over discectomy.

A proposed set of metrics for standardized outcome reporting in the management of low back pain

Background and purpose — Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. Patients and methods — An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. Results — Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. Interpretation — The outcome measures recommended here are structured around specific etiologies of LBP, span a patient’s entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

Arthroplasty versus fusion in single-level cervical degenerative disc disease: a Cochrane review.

Study Design. A systematic review of randomized controlled trials (RCTs). Objective. To assess the effects of arthroplasty versus fusion in the treatment of radiculopathy or myelopathy, or both, due to single-level cervical degenerative disc disease. Summary of Background Data. There is ongoing debate about whether fusion or arthroplasty is superior in the treatment of single-level cervical degenerative disc disease. Mainly because the intended advantage of arthroplasty compared with fusion, prevention of symptoms due to adjacent segment degeneration in the long term, is not confirmed yet. Until sufficient long-term results become available, it is important to know whether results of 1 of the 2 treatments are superior to the other in the first 1 to 2 years. Methods. We searched electronic databases for randomized controlled trials. We included randomized controlled trials that directly compared any type of cervical fusion with any type of cervical arthroplasty, with at least 1 year of follow-up. Study selection was performed independently by 3 review authors, and “risk of bias” assessment and data extraction were independently performed by 2 review authors. In case of missing data, we contacted the study authors or the study sponsor. We assessed the quality of evidence. Results. Nine studies (2400 participants) were included in this review; 5 of these studies had a low risk of bias. Results for the arthroplasty group were better than the fusion group for all primary comparisons, often statistically significant. For none of the primary outcomes was a clinically relevant difference in effect size shown. Quality of the evidence was low to moderate. Conclusion. There is low to moderate quality evidence that results are consistently in favor of arthroplasty, often statistically significant. However, differences in effect size were invariably small and not clinically relevant for all primary outcomes. Level of Evidence: 1

Provocative discography and lumbar fusion: is preoperative assessment of adjacent discs useful?

Study Design. A cohort study of clinical outcomes of lumbar fusion patients with preoperative assessment of adjacent levels by provocative discography. Objective. To evaluate whether the preoperative status of the adjacent discs, as determined by provocative discography, has an impact on the clinical outcome of lumbar fusion in chronic low back pain (LBP) patients. Summary of Background Data. The results of lumbar fusion in chronic LBP patients vary considerably and are hard to predict. It is believed that degenerative levels adjacent to a fused spinal segment may be a cause of continuing pain. In this respect, it is important to know whether preoperative degenerative or symptomatic adjacent levels have an adverse effect on patient outcomes after lumbar fusion. Methods. In 197 patients with an equivocal indication for lumbar fusion (two thirds were patients with prior spine surgery), the decision for either lumbar fusion or conservative management was determined by a temporary external transpedicular fixation trial. During the diagnostic workup, all patients had undergone provocative discography that included the assessment of the discs adjacent to the intended fusion levels. The individual changes in pain on a visual analog scale, assessed before treatment and at follow-up, and patient satisfaction were the measures of outcome. Results. In the 82 patients who underwent a lumbar fusion, no difference in outcome was found between those patients with degenerative or symptomatic discs adjacent to the fusion and those with normal adjacent discs. Conclusion. In this cohort study of chronic LBP patients with an uncertain indication for lumbar fusion, the preoperative status of adjacent levels as assessed by provocative discography did not appear to be related to the clinical outcome after fusion.

Spinal fusion for chronic low back pain: systematic review on the accuracy of tests for patient selection

BACKGROUND CONTEXT Spinal fusion is a common but controversial treatment for chronic low back pain (LBP) with outcomes similar to those of programmed conservative care. To improve the results of fusion, tests for patient selection are used in clinical practice. PURPOSE To determine the prognostic accuracy of tests for patient selection that are currently used in clinical practice to identify those patients with chronic LBP who will benefit from spinal fusion. STUDY DESIGN Systematic review of the literature. SAMPLE Studies that compared the results of magnetic resonance imaging (MRI), provocative discography, facet joint blocks, orthosis immobilization, and temporary external fixation with the clinical outcome of patients who underwent spinal fusion for chronic LBP. OUTCOME MEASURES To determine the prognostic accuracy of tests to predict the clinical outcome of spinal fusion in terms of sensitivity, specificity, and likelihood ratios (LRs). METHODS Data sources PubMed (1966 to November 2010), EMBASE (1974 to November 2010), and reference lists were searched without restriction by language or publication status. Two reviewers independently selected studies for inclusion, extracted data for analysis, and assessed the risk of bias with the Quality Assessment of Diagnostic Accuracy Studies checklist, modified for prognostic studies. Discrepancies were resolved by consensus. RESULTS Ten studies met the eligibility criteria. Immobilization by an orthosis (median [range] positive LR, 1.10 [0.94-1.13] and negative LR, 0.92 [0.39-1.12]), provocative discography (median [range] positive LR, 1.18 [0.70-1.71] and negative LR, 0.74 [0.24-1.40]), and temporary external fixation (median [range] positive LR, 1.22 [1.02-1.74] and negative LR, 0.58 [0.15-0.94]) failed to show clinically useful prognostic accuracy. Statistical pooling was not feasible because of different test protocols, variability in outcome assessment, and heterogeneous patient populations. No studies reporting on facet joint blocks or MRI could satisfy the inclusion criteria. Obscure patient selection, high risk of verification bias, and outcome assessment with poorly validated instruments precluded strong conclusions for all tests. CONCLUSIONS No subset of patients with chronic LBP could be identified for whom spinal fusion is a predictable and effective treatment. Best evidence does not support the use of current tests for patient selection in clinical practice.

Impact of guideline implementation by a fracture nurse on subsequent fractures and mortality in patients presenting with non-vertebral fractures

INTRODUCTION Systematic implementation of guidelines in patients presenting with a fracture increases identification of patients at high risk for subsequent fractures and contributes to a decreased fracture risk. Its effect on prevention of subsequent fractures and on mortality has not been documented. The aim of this study was to determine the impact of the implementation of specific guidelines on the risk of subsequent fractures and mortality in patients presenting with a non-vertebral fracture (NVF). PATIENTS AND METHODS Before-after impact analysis in consecutive patients older than 50 years who were admitted to the hospital with a NVF during 2 periods: pre-intervention group (n = 1,920, enrolled in 1999-2001) and intervention group (n = 1,335, enrolled in 2004-2006). The intervention consisted of a dedicated fracture nurse who systematically offered fracture risk evaluation and treatment according to available guidelines. The 2-year absolute risk (AR) and hazard ratios (HR, with 95% confidence interval (CI)) of subsequent NVFs and mortality were analysed between both groups after adjustment for age, sex and baseline fracture location by multivariable Cox regression and by intention-to-treat. RESULTS The AR of subsequent fracture was 9.9% before and 6.7% after intervention, indicating a decrease of 35% in the risk of subsequent fracture (HR 0.65; CI: 0.51-0.84, after adjustment for age, sex and baseline fracture location) and 17.9% and 11.6%, respectively, for subsequent mortality, indicating a decrease of 33% in the risk of subsequent mortality (HR: 0.67; CI: 0.55-0.81, after adjustment for age, sex and baseline fracture location). CONCLUSIONS Systematic implementation of guidelines for fracture prevention by a dedicated fracture nurse immediately after a NVF is associated with a significant reduction of the 2-year risk of subsequent NVF and mortality.