rhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) in real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres.

BACKGROUND: This is a Phase IV, national, multicentre, retrospective study to observe the real-world use of rhBMP-2 in France. HYPOTHESIS: There was no statistical hypothesis, the statistical analyses were descriptive in nature. PATIENTS AND METHODS: Data was collected from patient medical files in 10 French spinal centres. Primary objectives were to understand which patients were treated with rhBMP-2, commercialised in Europe as InductOs™ and how rhBMP-2 was used during spinal fusion surgery in France between 2011 and 2012. RESULTS: Four hundred patients (634 levels) treated with rhBMP-2 were included in the analysis. The most frequent primary diagnostic indication for rhBMP-2 use was degenerative disc disease (DDD; 129/400; 32.3% of patients) followed by spondylolisthesis (119/400; 29.8%), deformity (59/400; 14.8%) and pseudoarthrosis (29/400; 7.3%). The most frequently treated level was L4-L5 (33.8% of levels in 53.5% of patients); followed by L5-S1 (29.8%, 47.3%), L3-L4 (16.7%, 26.5%), and L2-L3 (7.3%, 11.5%), all other levels (less than 5% of patients). No interbody fusion device was used in 42.7% of levels. Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634). The most common procedure for rhBMP-2 treatment was posterior lumbar fusion (PLF) (221/634; 34.9% of levels), followed by anterior lumbar interbody fusion (ALIF) (188/634; 29.7%), posterior lumbar interbody fusion (PLIF) (111/634; 17.5%), lateral lumbar interbody fusion (LLIF) (106/634; 16.7%), transforaminal lumbar interbody fusion (TLIF) (4/634; 0.6%) and 'other' (4/634; 0.6%). Thirty-one adverse events of Interest (AEI) were recorded in 27 patients. One AEI was considered related to rhBMP-2. Unplanned secondary spine interventions at index level treated with rhBMP-2 were required in 4 patients. DISCUSSION: In years 2011 and 2012 when the surgeries captured in this retrospective study were done, rhBMP-2 was indicated for single level (L4-S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with DDD. The most common procedure for the treatment with rhBMP-2 was PLF (off-label use), followed by ALIF (on-label use). The safety findings confirm a predictable and manageable safety profile. LEVEL OF EVIDENCE: IV.

Three-month antibiotic therapy for early-onset postoperative spinal implant infections.

BACKGROUND: Optimal duration and modalities of antibiotic therapy for early-onset spinal implant infection (EOSII) remain controversial. METHODS: Between November 2004 and November 2007, we conducted a prospective, monocentric study to assess the efficacy of a 3-month course of antibiotics for patients diagnosed with EOSII, as defined by a proven deep infection of the surgical site occurring within 30 days after spinal instrumented surgery. All patients with EOSII underwent surgical debridement with implant retention. Combination antibiotic therapy was administered intravenously for 2 weeks. Treatment was switched orally for the following 10 weeks. RESULTS: 50 patients matched the inclusion criteria and were included in this study. The median age was 68 (interquartile range [IQR]: 51-75) years; the median ASA score was 2 (IQR: 2-2). Emergency spinal surgery had been performed in 18 patients. Staphylococcus aureus was the most frequently isolated pathogen (n=27), followed by Enterobacteriaceae (n=22) and coagulase-negative staphylococci (n=6). Seventeen patients had polymicrobial infections, and 13 patients (26%) had bacteremia. The median time from the first symptoms of infection to debridement surgery was 3 days (IQR: 2-5 days). Three patients underwent 2 debridement surgeries. The median follow-up was 43 (IQR: 34-54) months. The 2-year survival rate for those who did not experience treatment failure was 88% (95% confidence interval [CI]: 75.7%-95.5%). Three patients experienced treatment failure (6%, 95% CI: 1.3%-16.5%), including 1 relapse due to methicillin-susceptible S. aureus and 2 reinfections with another pathogen. CONCLUSIONS: In this homogenous cohort of 50 patients with EOSII, treatment consisting of debridement surgery with implant retention followed by combination antibiotic therapy for 3 months appeared safe and effective.

Influence of transforaminal lumbar interbody fusion procedures on spinal and pelvic parameters of sagittal balance.

INTRODUCTION: Restitution of sagittal balance is important after lumbar fusion, because it improves fusion rate and may reduce the rate of adjacent segment disease. The purpose of the present study was to describe the impact of transforaminal lumbar interbody fusion (TLIF) procedures on pelvic and spinal parameters and sagittal balance. MATERIALS AND METHODS: Forty-five patients who had single-level TLIF were included in this study. Pelvic and spinal radiological parameters of sagittal balance were measured preoperatively, postoperatively and at latest follow-up. RESULTS: Age at surgery averaged 58.4 (±9.6) years. Mean follow-up was 35.1 months (±4.1). Twenty-nine percent of the patients exhibited anterior imbalance preoperatively, with high pelvic tilt (17.6° ± 7.9°). Of the 32 (71%) patients well balanced before the procedure, 22 (70%) had a large pelvic tilt (>20°), due to retroversion of the pelvis as an adaptive response to the loss of lordosis. Three dural tears (7%) were reported intraoperatively. Interbody cages were more posterior than intended in 27% of the cases. Disc height and lumbar lordosis at fusion level significantly increased postoperatively (p < 0.05 and p < 0.001). Pelvic tilt was significantly reduced (p < 0.01) postoperatively, whereas the global sagittal balance was not significantly modified (p = 0.07). CONCLUSION: Single-level circumferential fusion helps patients reducing their pelvic compensation, but the amount of correction does not allow for complete correction of sagittal imbalance.

Camptocormia: the bent spine syndrome, an update.

Camptocormia, also referred to as bent spine syndrome (BSS) is defined as an abnormal flexion of the trunk, appearing in standing position, increasing during walking and abating in supine position. BSS was initially considered, especially in wartime, as a psychogenic disorder. It is now recognized that in addition to psychiatric syndromes, many cases of reducible BSS have a somatic origin related to a number of musculo-skeletal or neurological disorders. The majority of BSS of muscular origin is related to a primary idiopathic axial myopathy of late onset, appearing progressively in elderly patients. Diagnosis of axial myopathy first described by Laroche et al. is based upon CT/MRI examination demonstrating massive fatty infiltration of paravertebral muscles. The non-specific histological aspect includes an extensive endomysial fibrosis and fat tissue with irregular degenerated fibers. Weakness of the paravertebral muscles can be secondary to a wide variety of diseases generating diffuse pathologic changes in the muscular tissue. BSS can be the predominant and sometimes revealing symptom of a more generalized muscular disorder. Causes of secondary BSS are numerous. They must be carefully assessed and ruled out before considering the diagnosis of primary axial myopathy. The principal etiologies include on the one hand inflammatory myopathies, muscular dystrophies of late onset, myotonic myopathies, endocrine and metabolic myopathies, and on the other hand neurological disorders, principally Parkinson's disease. Camptocormia in Parkinsonism is caused by axial dystonia, which is the hallmark of Parkinson's disease. There is no specific pharmacologic treatment for primary axial myopathy. General activity, walking with a cane, physiotherapy, and exercises should be encouraged. Treatment of secondary forms of BSS is dependent upon the variety of the disorder generating the muscular pathology. Pharmacologic and general management of camptocormia in Parkinson's disease merge with that of Parkinsonism. Levodopa treatment, usually active on tumor rigidity and akinesia, has poor or negative effect on BSS.

Neurological and functional outcome after unstable cervicothoracic junction injury treated by posterior reduction and synthesis.

BACKGROUND CONTEXT: Unstable lesions of the cervicothoracic junction present a severe clinical problem for diagnosis, treatment, and prognosis. PURPOSE: The objective of the present study was to evaluate the neurological and functional outcomes following surgical treatments which combine in all cases posterior reduction and stabilization. STUDY DESIGN: Retrospective clinical and radiological study. PATIENT SAMPLES: Between September 1996 and September 2003, 30 patients underwent surgery for unstable fracture at the cervicothoracic junction. This group included 23 patients who sustained a motor vehicle accident, 5 who had fallen from a height, 1 case of ballistic trauma, and 1 person injured by diving in shallow water. There were 22 male and 8 female patients aged between 18 and 80, with an average age of 49. In 18 cases the lesion level was vertebra C7, in 5 cases vertebra T1, in 2 cases vertebra T2, and in 5 cases vertebra T3. Neurologically, on initial clinical examination 16 patients were classified Frankel A, 6 Frankel B, 2 Frankel C, and 6 Frankel D. Surgically, all the patients underwent posterior reduction and synthesis. Posterior stabilization was performed using rods and screws 3 times, plate-screw fixation 25 times, and rods and screws at the thoracic level linked to plate-screw at the cervical level 2 times. Spinal cord compression of more than two levels was associated with 25 cases. In these 25 cases, spinal cord decompression was associated with reduction and stabilization. OUTCOME MEASURES: Clinical outcome using neurological scale of Frankel, radiological outcomes using computed tomographic (CT) scans and plain X-ray evaluations. METHODS: Follow-up periods ranged from 11 to 48 months, with an average of 18 months. Seven patients died as a result of cardiopulmonary insufficiency within 4 months postoperative. Twenty-eight CT scans with sagittal and frontal slides were examined to evaluate postoperative reduction and to control screw placement. RESULTS: The observed reductions were satisfactory in 27 cases. In one case, reduction was satisfactory in the sagittal plane but lateral translation persisted in the frontal plane. Two mechanical failures with delayed mobilization of implants occurred. Bony fusion was recorded in all cases on CT scan evaluation. Complete or partial neurological recovery was observed in only 10 of 14 patients. The initial neurological status of these 14 patients was Frankel B, C, or D. CONCLUSION: The surgical procedure was chosen according to the particularity of the anatomical region and the possibility of associated medullar decompression. Insertion of pedicle screws in the upper thoracic portion in T1, T2, and T3 requires a careful technique and knowledge of the posterior projection points of the pedicles and their orientation in space. The high rate of fusion observed in these patients justified posterior reduction and stabilization. The high death rate and the low rate of neurological recovery in this group of patients emphasizes the severe prognosis of unstable injuries of the cervicothoracic junction. Considering the few mechanical failures observed at the last examination, the choice of the posterior approach was appropriate as the one stage procedure. Plate synthesis is preferable in fractures that do not require extension of synthesis beyond T2, whereas screws and rods systems are more appropriate for superior thoracic injuries. Despite early diagnosis and surgical treatment, the presence of neurological or pulmonary lesions resulted in increased mortality of the operated patients.