Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

Study Design Narrative Review Objectives The objective of this study was to compare publication status of clinical trials in adult spine surgery registered on ClinicalTrials.gov by funding source as well as to identify other trends in clinical trials in adult spine surgery. Methods All prospective, comparative, therapeutic (intervention-based) trials of adult spinal disease that were registered on ClinicalTrials.gov with a start date of January 1, 2000 and completion date before December 17, 2018 were included. Primary outcome was publication status of published or unpublished. A bivariate analysis was used to compare publication status to funding source of industry vs non-industry. Results Our search identified 107 clinical trials. The most common source of funding was industry (62 trials, 57.9% of total), followed by University funding (26 trials, 24.3%). The results of 76 trials (71.0%) were published, with industry-funded trials less likely to be published compared to non–industry-funded trials (62.9% compared to 82.2%, P = .03). Of the 31 unpublished studies, 13 did not report any results on ClinicalTrials.gov , and of those with reported results, none was a positive trial. Conclusions Clinician researchers in adult spine surgery should be aware that industry-funded trials are less likely to go on to publication compared to non–industry-funded trials, and that negative trials are frequently not published. Future opportunities include improvement in result reporting and in publishing negative studies.

Current concepts in hip–spine relationships: making them practical for total hip arthroplasty

Hip, spine, and pelvis move in coordination with one another during activity, forming the lumbopelvic complex (LPC). These movements are characterized by the spinopelvic parameters sacral slope, pelvic tilt, and pelvic incidence, which define a patient’s morphotype. LPC kinematics may be classified by various systems, the most comprehensive of which is the Bordeaux Classification. Hip–spine relationships in total hip arthroplasty (THA) may influence impingement, dislocation, and edge loading. Historical ‘safe zones’ may not apply to patients with impaired spinopelvic mobility; adjustment of cup inclination and version and stem version may be necessary to achieve functional orientation and avert complications. Stem design, bearing surface (including dual mobility), and head size are part of the armamentarium to treat abnormal hip–spine relationships. Special attention should be directed to patients with adult spine deformity or fused spine because they are at increased risk of complications after THA.

Reactivation of herpes simplex labialis following adult spine deformity correction surgery

Background: A depressed host defense is a major contributor to the oral shedding of herpes simplex virus (HSV) type 1. Here, we present an instance in which herpes simplex labialis was reactivated following major spinal deformity surgery. Case Description: A 59-year-old female underwent spinal deformity correction for lumbar degenerative scoliosis. On postoperative days 2–3, she presented with pyrexia (38°C) and tachycardia (94/min); by day 5 she had multiple ulcers around her lips and was HSV IgG positive. She had a remote history of herpes simplex I infection 7 years previously. Once started on oral acyclovir, the lesions improved, and by day 15 postoperative, her pyrexia and all lesions completely resolved. Conclusion: HSV-1 should be suspected in patients with a previous history of HSV and postoperative pyrexia. Adequate prophylactic administration of acyclovir should result in resolution of these outbreaks, in this case, attributed to overly extensive spinal deformity surgery.