Prospective randomized controlled comparison of posterior vs. posterior–anterior stabilization of thoracolumbar incomplete cranial burst fractures in neurological intact patients: the RASPUTHINE pilot study

Abstract

Purpose

If surgery for thoracolumbar incomplete cranial burst fractures (Magerl A3.1.1) is necessary, the ideal stabilization strategy still remains undetermined. To justify posterior–anterior stabilization, which generates higher costs and potentially higher morbidity vs. posterior-only stabilization, clinical trials with sufficient power and adequate methodology are required. This prospective randomized single-centre pilot trial was designed to enable sufficient sample-size calculation for a randomized multicentre clinical trial (RASPUTHINE).

Methods

Patients with a traumatic thoracolumbar (Th11–L2) incomplete burst fracture (Magerl A3.1.1) were randomly assigned either to the interventional group (posterior–anterior) or to the control group (posterior-only). Primary endpoint of the study was the clinical outcome measured using the Oswestry Disability Index (ODI) at 24 months. Radiological outcome was assessed as secondary endpoint by evaluation of mono- and bisegmental kyphotic angulation and monosegmental fusion.

Results

21 patients were randomly assigned to interventional group (n = 9) or control group (n = 12). One posterior-only treated patient showed a severe initial loss of correction resulting in a crossover to additional anterior bisegmental fusion. The ODI measures at the primary study endpoint showed less but insignificant (p = 0.67) disability for the interventional group over the control group (13.3 vs. 19.3%). Comparison of preoperative bisegmental kyphosis in supine position with the bisegmental kyphosis at 24-month FU in upright position showed a worsened kyphosis for the control group (10.7° → 15.6°), whereas an improved kyphosis (11° → 8.3°) was detectable for the interventional group.

Conclusion

The results of this pilot RCT showed less disability for the posterior–anterior group linked with a significant better restoration of the sagittal profile in comparison with the posterior-only group. To detect a clinically significant difference using the ODI and assuming a 20% loss of FU rate, a total of 266 patients have to be studied in the multicentre trial.

from #ORL-AlexandrosSfakianakis via ola Kala on Inoreader http://ift.tt/2zBB9ZI