Lumbar fusion remains the gold standard for the treatment of discogenic back pain. Total disc replacement has fallen out of favor in many institutions. Other motion preservation alternatives, such as nucleus replacement, have had limited success and none are commercially available at this time. Two prospective, nonrandomized multicenter studies of lumbar disc nucleus replacement using the PerQdisc 2.0 nucleus replacement device in patients with lumbar discogenic back pain. Early clinical results are presented. A total of 16 patients from 4 international sites (Germany, Paraguay, Canada and Belgium) were enrolled in the trial between May 2019 and February 2021. Data collection points include baseline and postoperatively at 1, 2, 6, and 12 months. Clinical outcome measures were obtained from the Visual Analog Scale (VAS) for back and leg pain, Oswestry Disability Index (ODI), SF-12V2, Analgesic Score (AS), and radiographic assessments. Prospectively gathered data on patient reported outcomes, neurological outcome, surgical results, radiological analysis, and any adverse events. 16 patients had successful implantation of the device. There have been no expulsions of the device. Early postoperative results are available in 13/16 patients at 6 months and 11/16 patients at 12 months. There have been 4 (25%) revision surgeries 3–12 months post implantation between the two trials. 12 of 13 (92%) patients had Minimal Clinically Important Difference (MCID) in ODI at 6 months and 10 of 11 (91%) at 12 months. Mean decrease in ODI from baseline to 12 months was 44.8. At 12 months 8 (73%) patients are not taking pain medication, 1 (9%) patient is taking a
The purpose of this study was to evaluate the incidence and analyze the trends of surgeon-reported complications following surgery for adolescent idiopathic scoliosis (AIS) over a 13-year period from the Scoliosis Research Society (SRS) Morbidity and Mortality database. All patients with AIS between ten and 18 years of age, entered into the SRS Morbidity and Mortality database between 2004 and 2016, were analyzed. All perioperative complications were evaluated for correlations with associated factors. Complication trends were analyzed by comparing the cohorts between 2004 to 2007 and 2013 to 2016.Aims
Methods
This prospective multicentre study was undertaken
to determine segmental movement, disc height and sagittal alignment
after total disc replacement (TDR) in the lumbosacral spine and
to assess the correlation of biomechanical properties to clinical
outcomes. A total of 173 patients with degenerative disc disease and low
back pain for more than one year were randomised to receive either
TDR or multidisciplinary rehabilitation (MDR). Segmental movement
in the sagittal plane and disc height were measured using distortion
compensated roentgen analysis (DCRA) comparing radiographs in active flexion
and extension. Correlation analysis between the range of movement
or disc height and patient-reported outcomes was performed in both
groups. After two years, no significant change in movement in the
sagittal plane was found in segments with TDR or between the two
treatment groups. It remained the same or increased slightly in
untreated segments in the TDR group and in this group there was
a significant increase in disc height in the operated segments.
There was no correlation between segmental movement or disc height
and patient-reported outcomes in either group. In this study, insertion of an intervertebral disc prosthesis
TDR did not increase movement in the sagittal plane and segmental
movement did not correlate with patient-reported outcomes. This
suggests that in the lumbar spine the movement preserving properties
of TDR are not major determinants of clinical outcomes. Cite this article:
