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Sascha Mann, Michael Schütze, Steffen Sola and Jürgen Piek

Object

Pyogenic vertebral osteomyelitis is of special interest to neurosurgeons because it often results in acute neurological deterioration and requires a combination of adequate surgical and conservative treatment. The aim of the current study was to evaluate the strategy of a primary surgical approach to this disease.

Methods

A group of 24 patients with the clinical and radiological signs of acute pyogenic spondylodiscitis was prospectively followed from 1998 to 2004. Of these, 20 had underlying diseases such as diabetes mellitus, chronic alcoholism, and liver cirrhosis. The main causative organism was Staphylococcus aureus. Most infections were localized in the thoracic or lumbar spine (10 cases each); 15 infections were associated with epidural abscesses. Because of a delay in diagnosis, 13 patients presented with neurological deficits on admission.

Patients with a complete or rapidly progressing neurological deficit underwent immediate surgery. In patients with minor or no deficits or in a stable neurological condition, surgery was delayed for 3 to 5 days. This group was treated with immobilization and intravenous antibiotic drugs before surgery. Surgical procedures included ventral, dorsal, and combined approaches in one- or two-stage operations. Antibiotic treatment included the use of broad-spectrum antibiotic drugs delivered intravenously for at least 10 days, followed by orally administered antibiotics for 3 months.

Twenty patients were independent on follow-up review, 15 with no or minor handicaps. Severe septicemia and multiorgan failure developed in two patients, and these two died of their disease. Major complications were mainly due to long-term antibiotic therapy.

Conclusions

Surgical treatment is the modality of choice in patients with acute spinal osteomyelitis. It is especially indicated in patients with progressive or severe neurological deficits and spinal deformity. In experienced hands, surgery is safe and offers the advantages of spinal cord decompression, immediate mobilization, and correction of spinal deformity. The decision whether an anterior or posterior approach should be used must be made on an individual basis.

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Sven Schmidt, Joerg Franke, Michael Rauschmann, Dieter Adelt, Matteo Mario Bonsanto and Steffen Sola

OBJECTIVE

Surgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS.

METHODS

Under approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany. Patients had moderate to severe LSS at 1 or 2 adjacent segments from L-3 to L-5. Outcomes were evaluated up to 2 years postoperatively, including Oswestry Disability Index (ODI) scores, the presence of secondary surgery or lumbar injections, neurological status, and the presence of device- or procedure-related severe adverse events. The composite clinical success (CCS) was defined as combining all 4 of these outcomes, a success definition validated in a US FDA pivotal trial. Additional secondary end points included visual analog scale (VAS) scores, Zürich Claudication Questionnaire (ZCQ) scores, narcotic usage, walking tolerance, and radiographs.

RESULTS

The overall follow-up rate was 91% at 2 years. There were no significant differences in patient-reported outcomes at 24 months (p > 0.05). The CCS was superior for the D+ILS arm (p = 0.017). The risk of secondary intervention was 1.75 times higher among patients in the DA group than among those in the D+ILS group (p = 0.055). The DA arm had 228% more lumbar injections (4.5% for D+ILS vs 14.8% for DA; p = 0.0065) than the D+ILS one. Patients who underwent DA had a numerically higher rate of narcotic use at every time point postsurgically (16.7% for D+ILS vs 23% for DA at 24 months). Walking Distance Test results were statistically significantly different from baseline; the D+ILS group had > 2 times the improvement of the DA. The patients who underwent D+ILS had > 5 times the improvement from baseline compared with only 2 times the improvement from baseline for the DA group. Foraminal height and disc height were largely maintained in patients who underwent D+ILS, whereas patients treated with DA showed a significant decrease at 24 months postoperatively (p < 0.001).

CONCLUSIONS

This study showed no significant difference in the individual patient-reported outcomes (e.g., ODI, VAS, ZCQ) between the treatments when viewed in isolation. The CCS (survivorship, ODI success, absence of neurological deterioration or device- or procedure-related severe adverse events) is statistically superior for ILS. Microsurgical D+ILS increases walking distance, decreases compensatory pain management, and maintains radiographic foraminal height, extending the durability and sustainability of a decompression procedure.

Clinical trial registration no.: NCT01316211 (clinicaltrials.gov)

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Hans-Jörg Meisel, Lubomír Jurák, Jussi Antinheimo, Ricardo Arregui, Bernhard Bruchmann, Mario Čabraja, Fabrizio Caroli, Stefan Kroppenstedt, Jan Kryl, Juha Pohjola, Ian Shackleford, Steffen Sola, Peter Stosberg, Jan Stulik, Christian Woiciechowsky and Petr Suchomel

OBJECTIVE

Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis.

METHODS

A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis.

RESULTS

Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from −2.4° preoperatively to −6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment.

CONCLUSIONS

The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR.

Clinical trial registration no.: NCT02492724 (clinicaltrials.gov)