gms | German Medical Science

Objective: The RASPUTHINE (RAndomization of Stabilization Procedures for Unstable THoracolumbar spINE fractures) trial aims at comparing the two most frequently used surgical stabilization techniques for incomplete burst fractures in Germany. This pilot study was designed to allow sample size and power analysis for RASPUTINE.

Method: 22 patients (average age 46 ± 13 years) with traumatic thoracolumbar (T11-L2) incomplete cranial burst fractures (AO A3.1.1) were treated by posterior bisegmental stabilization and monosegmental fusion using local bone graft. Afterwards patients were randomised to either an additional mono-segmental anterior stabilization using an iliac crest bone graft and plate (posterior-anterior group, n = 12) or no additional anterior stabilisation (posterior only group, n = 10). Posterior implant removal was performed after 12 months in both groups. All patients were followed for 24 months. Evaluation was performed preoperative and at 3, 12 (prior to implant removal) and 24 months postoperative including clinical (Oswestry Disability Index, VAS-Spine Score, EQ5D, subjective patient satisfaction) and radiographic parameters (McCormack-Score, bisegmental kyphosis-/scoliosis angle, CT scan at 12 months). Restoration of spinal alignment after 24 months measured by bisegmental kyphosis angle was defined as primary endpoint and functional scores (ODI, VAS Spine Score) as secondary endpoints of the study.

Results: There was no significant difference in demographic, clinical and radiographic parameters between the groups preoperatively. After posterior stabilisation both groups showed similar (p=0.996) correction of kyphotic deformity (bisegmental kyphosisangle improvement: 7°± 5°). Additional anterior stabilisation resulted in a supplementary correction by 2.8° ± 2.3°. Loss of correction at 3 and 12 months postoperative was not significantly different. However, after implant removal loss of correction increased significantly (p=0.03) more in the posterior-only group (8.4° ± 3° vs. 4° ± 2.1°) resulting in an overall correction (primary endpoint) in the posterior-anterior group of 4.8° ± 5,8° and in the posterior-only group of -1,5° ± 7,7° (difference 6.3°, p=0,2).

Conclusions: Posterior-anterior stabilisation of A3.1.1 fractures of the thoracolumbar junction showed a better, but statistically insignificant, restoration of spinal alignment after 24 months (primary endpoint) and similar functional scores (secondary endpoint) compared to posterior-only stabilisation.