Two-level ACDF with a zero-profile stand-alone spacer compared to conventional plating: a prospective randomized single-center study.

PURPOSE: Stand-alone zero-profile devices have already proven safety, and a reduced dysphagia rate was assumed. So far, no level-one evidence is available to prove the proposed advantages of zero-profile implants in multilevel procedures. The aim of this RCT was to compare the clinical and radiological outcome of a zero-profile spacer versus cage + plate in two-level ACDF. METHODS: Consecutive patients with contiguous two-level cDD were randomly assigned either to the interventional group (zero-profile device) or to the control group (cage + plate). Primary endpoint of the study was the prevalence of dysphagia at 24 months. Disability, progress of adjacent segment degeneration, fusion status and loss of correction were analyzed as secondary outcome measure. Primary outcome parameter was statistically analyzed by Chi-square test. RESULTS: Forty-one patients met inclusion criteria and were randomly assigned to the interventional and the control group. Dysphagia was frequent in either group at 3 months FU favoring interventional group (p = 0.078). At final FU, less patients of the interventional group complained about dysphagia, but the difference was not significant. No relevant differences at final FU were recorded for NPDI, loss of correction and adjacent-level degeneration. Fusion rate was slightly lower in the interventional group. DISCUSSION: Two-level ACDF either by a stand-alone zero-profile spacer or cage + plate is safe. Using a zero-profile cage dysphagia was infrequent at 24 months, but the value did not reach statistical significance in comparison with the cage + plate. Hence, this randomized trial was not able to prove the proposed clinical superiority for dysphagia rates for zero-profile anchored spacer in two-level cDD.

[Minimally invasive techniques for traumatic injuries of the cervical spine]. / Minimal-invasive Techniken bei traumatischen Halswirbelsäulenverletzungen.

Nowadays, although minimally invasive procedures are the standard for the treatment of thoracolumbar spinal injuries, these techniques are not yet established for the cervical spine. This is due to anatomical and technical reasons and also due to the fact that the classical anterior decompression and fusion procedure already fulfils the criteria of minimally invasiveness and is suitable for the vast majority of injuries. The existing literature consists mainly of case reports and small comparative cohort studies, the results of which are presented. There is a minimally invasive variant for nearly all open procedures, mainly in the upper cervical spine but also in the lower cervical spine. The further development of these promising techniques is still pending.

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

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° â†’ 15.6°), whereas an improved kyphosis (11° â†’ 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.

Single- and Multilevel Corpectomy and Vertebral body replacement for treatment of spinal infections. A retrospective single-center study of 100 cases.

Background: The optimal operative approach for treating spinal infections remains a subject of debate. Corpectomy and Vertebral Body Replacement (VBR) have emerged as common modalities, yet data on their feasibility and complication profiles are limited. Methods: This retrospective single-center study examined 100 consecutive cases (2015-2022) that underwent VBR for spinal infection treatment. A comparison between Single-level-VBR and Multi-level-VBR was performed, evaluating patient profiles, revision rates, and outcomes. Results: Among 360 cases treated for spinal infections, 100 underwent VBR, located in all spinal regions. Average clinical and radiologic follow-up spanned 1.5 years. Single-level-VBR was performed in 60 cases, Two-level-VBR in 37, Three-level-VBR in 2, and Four-level-VBR in one case.Mean overall sagittal correction reached 10° (range 0-54°), varying by region. Revision surgery was required in 31 cases. Aseptic mechanical complications (8% pedicle screw loosening, 3% cage subsidence, 6% aseptic adjacent disc disease) were prominent reasons for revision. Longer posterior constructs (>4 levels) had significantly higher revision rates (p < 0.01). General complications (wound healing, hematoma) followed, along with infection relapse and adjacent disc infection (9%) and neurologic impairment (1%).Multilevel-VBR (≥2 levels) displayed no elevated cage subsidence rate compared to Single-level-VBR. Three deaths occurred (43-86 days post-op), all in the Multi-level-VBR group. Conclusion: This study, reporting the largest number of VBR cases for spinal infection treatment, affirmed VBR's effectiveness in sagittal imbalance correction. The overall survival was high, while reinfection rates matched other surgical studies. Anterior procedures have minimal implant related risks, but extended dorsal instrumentation elevates revision surgery likelihood.

A new zero-profile implant for stand-alone anterior cervical interbody fusion.

BACKGROUND: Several studies suggest fusion rates are higher with anterior cervical discectomy and fusion procedures if supplemented with a plate. However, plates may be associated with higher postoperative morbidity and higher rates of dysphagia. This led to the development of a cervical stand-alone cage with integrated fixation for zero-profile segmental stabilization. QUESTIONS/PURPOSES: We asked whether this new implant would be associated with a low rate of dysphagia and other short-term complications in patients having anterior cervical discectomy and fusion and would be able to achieve solid fusion and maintain postoperative reduction in pain. METHODS: We prospectively followed 38 patients with radiculopathy/myelopathy undergoing anterior cervical discectomy and fusion using the new implant. Intraoperative parameters, clinical features (Neck Pain Disability Index, visual analog scale score for neck/arm pain, Odom's criteria), and dysphagia scores were recorded. Radiographs were taken to assess implant failure. Thirty-four patients had a minimum 6 months' followup (mean, 8 months; range, 6-11 months). RESULTS: Three patients at 6 weeks and one patient at 6 months complained about minor dysphagia-related symptoms. There was no hardware failure recordable and all patients had evidence of fusion. Compared to preoperatively, visual analog scale pain score and Neck Pain Disability Index were reduced at 6 weeks' followup without change during further followup. CONCLUSIONS: The new cervical stand-alone anterior fusion device allows decompression and fusion with low complication rates. The incidence of chronic postoperative dysphagia was infrequent in comparison to published data. Prospective randomized trials with more patients and longer followup are necessary to confirm these observations. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.