Two papers presented for the Scoliosis Research Society and published in Spinal Deformity examine the Vertical Expandable Prosthetic Titanium Rib system for early-onset scoliosis.
The first study conducted a retrospective review of institutional review board-approved prospective database of 915 consecutive patients. There were 95 patients who underwent those surgeries during the study period, with the average age being 7.7 years old and each patient had an average of 11.5 surgeries. The researchers found:
1. There were 173 complications reported with one patient who reported 15 complications.
2. Most patients had one or two complications; 16 patients reported no complications.
3. The complication rate didn't increase as the number of surgeries increased.
4. There were 96 disease-related complications and 77 device-related complications.
5. The overall complication rate was around 20 percent per year, with device complications remaining steady at 8.6 percent per year despite the surgeons' increased experience with the procedure.
6. Researchers concluded complications are "relatively common and expected" in managing early onset scoliosis using growth-friendly instrumentation.
The second article was an analysis of complications. This retrospective study was conducted on prospectively collected data from 2007 to 2012 from eight sites. Every patient had at least four surgical procedures. There were 213 patients who had 55 infections requiring treatment in 38 patients and average follow-up was 4.1 years.
The researchers for this study found:
1. Around 8 percent of the patients developed infection requiring operative debridement.
2. There were different infection rates among the sites, ranging from 2.9 percent to 42.9 percent.
3. After the surgery was performed, there was typically 70 days before the infection appeared.
4. The infection was most often caused by gram-positive bacteria: 80 percent, with the most prevalent being methicillin-sensitive Staphylococcus aureus, present in 45 percent of those patients.
5. There were 20 patients, or 53 percent, who had partial or complete implant removal to resolve infections, but only three of the procedures resulted in abandoning the VEPTR treatment.
6. There weren't any differences in infection rate across primary C-EOS diagnosis categories. There was also no difference based on ASA scores.
7. The odds ratio of an infection after the implant procedure, versus an expansion, was 2.8 after controlling for study site.