BACKGROUND CONTEXT: Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN).

IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of −20.3 (CI −25.9 to −14.7 points; p<0.001)), VAS pain improvement (difference of −2.5 cm between arms (CI −3.37 to −1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56).Discussion/ConclusionBVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.

As a result of axial compression, traumatic vertebral burst fractures disrupt the anterior column, leading to segmental instability and cord compression. In situations with diminished anterior column support, pedicle screw fixation alone may lead to delayed kyphosis, nonunion, and hardware failure. Vertebroplasty and kyphoplasty (balloon-assisted vertebroplasty) have been used in an effort to provide anterior column support in traumatic burst fractures. Cited advantages are providing immediate stability, improving pain, and reducing hardware malfunction. When used in isolation or in combination with posterior instrumentation, these techniques theoretically allow for improved fracture reduction and maintenance of spinal alignment while avoiding the complications and morbidity of anterior approaches. Complications associated with cement use (leakage, systemic effects) are similar to those seen in the treatment of osteoporotic compression fractures; however, extreme caution must be used in fractures with a disrupted posterior wall.

This study compared patients who underwent treatment with short or long cephalomedullary nails with integrated cephalocervical screws and linear compression. Patients with AO/OTA 31-A2 or A3 pertrochanteric fractures treated with either short (n=72) or long (n=97) InterTAN (Smith & Nephew, Memphis, Tennessee) cephalomedullary nails were reviewed. Information on perioperative measures (estimated blood loss, surgical time, and fluoroscopy time) and postoperative orthopedic complications (infection, implant failure, screw cutout, and periprosthetic femur fracture) was included. Estimated blood loss (short nail, 161 mL; long nail, 208 mL; P=.002) and surgical time (short nail, 64 minutes; long nail, 83 minutes; P=.001) were lower in the short nail group. There were no differences in fluoroscopy time (short nail, 90 seconds; long nail, 142 seconds; P=.071) or rates of infection (short nail, 1.4%; long nail, 3.1%; P=.637) or overall orthopedic complications (short nail, 11.1%; long nail, 9.3%; P=.798) between the 2 groups. The long nail group had a trend toward more screw cutouts (long nail, 5.2%; short nail, 0.0%; P=.134) but fewer periprosthetic femur fractures (short nail, 8.3%; long nail, 0.0%; P=.013). This study found a similar overall rate of orthopedic complications between short and long nails with integrated cephalocervical screws and linear compression. These results confirm the suspected advantages of short nails, including faster surgery and less blood loss; however, the rate of periprosthetic femur fracture remains high, despite changes to implant design. [Orthopedics. 2017; 40(2):83-88.].

on behalf of the INTRACEPT trial investigators, Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results,