Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2) : The Yale Open Data Access Medtronic Project

Background: It is uncertain whether the replication of systematic reviews, particularly those with the same objectives and resources, would employ similar methods and/or arrive at identical findings. We compared the results and conclusions of two concurrent systematic reviews undertaken by two independent research teams provided with the same objectives, resources, and individual participant-level data. Methods: Two centers in the USA and UK were each provided with participant-level data on 17 multi-site clinical trials of recombinant human bone morphogenetic protein-2 (rhBMP-2). The teams were blinded to each other's methods and findings until after publication. We conducted a retrospective structured comparison of the results of the two systematic reviews. The main outcome measures included (1) trial inclusion criteria; (2) statistical methods; (3) summary efficacy and risk estimates; and (4) conclusions. Results: The two research teams' meta-analyses inclusion criteria were broadly similar but differed slightly in trial inclusion and research methodology. They obtained similar results in summary estimates of most clinical outcomes and adverse events. Center A incorporated all trials into summary estimates of efficacy and harms, while Center B concentrated on analyses stratified by surgical approach. Center A found a statistically significant, but small, benefit whereas Center B reported no advantage. In the analysis of harms, neither showed an increased cancer risk at 48 months, although Center B reported a significant increase at 24 months. Conclusions reflected these differences in summary estimates of benefit balanced with small but potentially important risk of harm. Conclusions: Two independent groups given the same research objectives, data, resources, funding, and time produced broad general agreement but differed in several areas. These differences, the importance of which is debatable, indicate the value of the availability of data to allow for more than a single approach and a single interpretation of the data. Systematic review registration: PROSPERO CRD42012002040and CRD42012001907

Imaging the spine in arthritis—a pictorial review

Spinal involvement is frequent in rheumatoid arthritis (RA) and seronegative spondyloarthritides (SpA), and its diagnosis is important. Thus, MRI and CT are increasingly used, although radiography is the recommended initial examination. The purpose of this review is to present the typical radiographic features of spinal changes in RA and SpA in addition to the advantages of MRI and CT, respectively. RA changes are usually located in the cervical spine and can result in serious joint instability. Subluxation is diagnosed by radiography, but supplementary MRI and/or CT is always indicated to visualise the spinal cord and canal in patients with vertical subluxation, neck pain and/or neurological symptoms. SpA may involve all parts of the spine. Ankylosing spondylitis is the most frequent form of SpA and has rather characteristic radiographic features. In early stages it is characterised by vertebral squaring and condensation of vertebral corners, in later stages by slim ossifications between vertebral bodies, vertebral fusion, arthritis/ankylosis of apophyseal joints and ligamentous ossification causing spinal stiffness. The imaging features of the other forms of SpA can vary, but voluminous paravertebral ossifications often occur in psoriatic SpA. MRI can detect signs of active inflammation as well as chronic structural changes; CT is valuable for detecting fracture

Long Term Results of Anterior Corpectomy and Fusion for Cervical Spondylotic Myelopathy

BACKGROUND: Results showed good clinical outcomes of anterior corpectomy and fusion (ACCF) for patients with cervical spondylotic myelopathy (CSM) during a short term follow-up; however, studies assessing long term results are relatively scarce. In this study we intended to assess the long term clinical and radiographic outcomes, find out the factors that may affect the long term clinical outcome and evaluate the incidence of adjacent segment disease (ASD). METHODS: This is a retrospective study of 145 consecutive CSM patients on ACCF treatment with a minimum follow-up of 5 years. Clinical data were collected from medical and operative records. Patients were evaluated by using the Japanese Orthopedic Association (JOA) scoring system preoperatively and during the follow-up. X-rays results of cervical spine were obtained from all patients. Correlations between the long term clinical outcome and various factors were also analyzed. FINDINGS: Ninety-three males and fifty-two females completed the follow-up. The mean age at operation was 51.0 years, and the mean follow-up period was 102.1 months. Both postoperative sagittal segmental alignment (SSA) and the sagittal alignment of the whole cervical spine (SACS) increased significantly in terms of cervical lordosis. The mean increase of JOA was 3.8 ± 1.3 postoperatively, and the overall recovery rate was 62.5%. Logistic regression analysis showed that preoperative duration of symptoms >12 months, high-intensity signal in spinal cord and preoperative JOA score ≤ 9 were important predictors of the fair recovery rate (≤ 50%). Repeated surgery due to ASD was performed in 7 (4.8%) cases. CONCLUSIONS: ACCF with anterior plate fixation is a reliable and effective method for treating CSM in terms of JOA score and the recovery rate. The correction of cervical alignment and the repeated surgery rate for ASD are also considered to be satisfactory

Complications and pitfalls of lumbar interlaminar and transforaminal epidural injections

Lumbar interlaminar and transforaminal epidural injections are used in the treatment of lumbar radicular pain and other lumbar spinal pain syndromes. Complications from these procedures arise from needle placement and the administration of medication. Potential risks include infection, hematoma, intravascular injection of medication, direct nerve trauma, subdural injection of medication, air embolism, disc entry, urinary retention, radiation exposure, and hypersensitivity reactions. The objective of this article is to review the complications of lumbar interlaminar and transforaminal epidural injections and discuss the potential pitfalls related to these procedures. We performed a comprehensive literature review through a Medline search for relevant case reports, clinical trials, and review articles. Complications from lumbar epidural injections are extremely rare. Most if not all complications can be avoided by careful technique with accurate needle placement, sterile precautions, and a thorough understanding of the relevant anatomy and contrast patterns on fluoroscopic imaging