Clinical and radiological evaluation of Trabecular Metal and the Smith–Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up

A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal™ (TM) to the traditional Smith–Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A–P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4°. Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients’ global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith–Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants

Cervical disc herniation and cervical spondylosis surgically treated by Cloward procedure: a 10-year-minimum follow-up study

BACKGROUND: Cervical degenerative pathology produces pain and disability, and if conservative treatment fails, surgery is indicated. The aim of this study was to determined whether anterior decompression and interbody fusion according to Cloward is effective for treating segmental cervical degenerative pathology and whether the results are durable after a 10-year-minimum follow-up. MATERIALS AND METHODS: Fifty-one patients affected by single-level cervical degenerative pathology between C4 and C7 were surgically treated by the Cloward procedure. Clinical evaluation was rated using the Neck Disability Index (NDI) and the visual analog scale (VAS). At last follow-up, the outcomes were rated according to Odom's criteria. On radiographs, the sagittal segmental alignment (SSA) of the affected level and the sagittal alignment of the cervical spine (SACS) were measured. RESULTS: Average NDI was 34 preoperatively and 11 at last follow-up. Average VAS was 7 preoperatively and 1 at last follow-up. According to Odom's criteria, the outcome was considered excellent in 18 cases, good in 22, and fair in 11. Average SSA was 0.5 +/- 2.1 preoperatively, 1.8 +/- 3.8 at 6 months, and 1.8 +/- 5.7 at last follow-up. Average SACS was 16.5 +/- 4.0 preoperatively, 20.9 +/- 5.8 at 6 months, and 19.9 +/- 6.4 at last follow-up. Degenerative changes at the adjacent levels were observed in 18 patients (35.3%). CONCLUSIONS: The Cloward procedure proved to be a suitable and effective technique for treating segmental cervical degenerative pathology, allowing good clinical and radiographic outcomes even at a long-term follow-up

Using proximity extension proteomics assay to discover novel biomarkers associated with circulating leptin levels in patients with type 2 diabetes

We aimed to discover novel associations between leptin and circulating proteins which could link leptin to the development of cardiovascular disease in patients with type 2 diabetes (T2DM). In a discovery phase, we investigated associations between 88 plasma proteins, assessed with a proximity extension assay, and plasma leptin in a cohort of middle-aged patients with T2DM. Associations passing the significance threshold of a False discovery rate of 5% (corresponding to p&lt;0.0017) were replicated in patients with T2DM in an independent cohort. We also investigated if proteins mediated the longitudinal association between plasma leptin and the incidence of major cardiovascular events (MACE). One protein, adipocyte fatty acid binding protein (A-FABP), was significantly associated with leptin in both the discovery phase [95% CI (0.06, 0.17) p=0.00002] and the replication cohort [95% CI (0.12, 0.39) p=0.0003]. Multiplicative interaction analyses in the two cohorts suggest a stronger association between A-FABP and leptin in men than in women. In longitudinal analyses, the association between leptin and MACE was slightly attenuated after adding A-FABP to the multivariate model. Our analysis identified a consistent association between leptin and A-FABP in two independent cohorts of patients with T2DM, particularly in men.Trial registration: ClinicalTrials.gov identifier NCT 01049737

Anterior Spinal Overgrowth is the Result of the Scoliotic Mechanism and is Located in the Disc

STUDY DESIGN: Cross-sectional. OBJECTIVE: To investigate the presence and magnitude of anterior spinal overgrowth in neuromuscular scoliosis and compare this to the same measurements in idiopathic scoliosis and healthy spines. SUMMARY OF BACKGROUND DATA: Anterior spinal overgrowth has been described as a potential driver for the onset and progression of adolescent idiopathic scoliosis (AIS). Whether this anterior overgrowth is specific for AIS or also present in non-idiopathic scoliosis has not been reported. METHODS: Supine CT scans of thirty AIS patients (thoracic Cobb 21-81°), thirty neuromuscular (NM) scoliotic patients (thoracic Cobb 19-101°) and thirty non-scoliotic controls were used. The difference in length in per cents between the anterior and posterior side (((ΔA-P)/P)*100%, abbreviated to A-P%) of each vertebral body and intervertebral disc, and between the anterior side of the spine and the spinal canal (A-C%) were determined. RESULTS: The A-P% of the thoracic curves did not differ between the AIS (+1.2 ± 2.2%) and NM patients (+0.9 ± 4.1%, P = 0.663), both did differ, however, from the same measurements in controls (-3.0 ± 1.6%; P < 0.001) and correlated linearly with the Cobb angle (AIS r = 0.678, NM r = 0.687). Additional anterior length was caused by anterior elongation of the discs (AIS: A-P% disc +17.5 ± 12.7% versus A-P% body -2.5 ± 2.6%; P < 0.001, NM: A-P% disc +19.1 ± 18.0% versus A-P% body -3.5 ± 5.1%; P < 0.001). The A-C% T1-S1 in AIS and NM patients were similar (+7.9 ± 1.8% and +8.7 ± 4.0%, P = 0.273), but differed from the controls (+4.2 ± 3.3%; P < 0.001). CONCLUSIONS: So called anterior overgrowth has been postulated as a possible cause for idiopathic scoliosis, but apparently it occurs in scoliosis with a known origin as well. This suggests that it is part of a more generalized scoliotic mechanism, rather than its cause. The fact that the intervertebral discs contribute more to this increased anterior length than the vertebral bodies suggests an adaptation to altered loading, rather than a primary growth disturbance

Anterior Spinal Overgrowth is the Result of the Scoliotic Mechanism and is Located in the Disc

STUDY DESIGN: Cross-sectional. OBJECTIVE: To investigate the presence and magnitude of anterior spinal overgrowth in neuromuscular scoliosis and compare this to the same measurements in idiopathic scoliosis and healthy spines. SUMMARY OF BACKGROUND DATA: Anterior spinal overgrowth has been described as a potential driver for the onset and progression of adolescent idiopathic scoliosis (AIS). Whether this anterior overgrowth is specific for AIS or also present in non-idiopathic scoliosis has not been reported. METHODS: Supine CT scans of thirty AIS patients (thoracic Cobb 21-81°), thirty neuromuscular (NM) scoliotic patients (thoracic Cobb 19-101°) and thirty non-scoliotic controls were used. The difference in length in per cents between the anterior and posterior side (((ΔA-P)/P)*100%, abbreviated to A-P%) of each vertebral body and intervertebral disc, and between the anterior side of the spine and the spinal canal (A-C%) were determined. RESULTS: The A-P% of the thoracic curves did not differ between the AIS (+1.2 ± 2.2%) and NM patients (+0.9 ± 4.1%, P = 0.663), both did differ, however, from the same measurements in controls (-3.0 ± 1.6%; P < 0.001) and correlated linearly with the Cobb angle (AIS r = 0.678, NM r = 0.687). Additional anterior length was caused by anterior elongation of the discs (AIS: A-P% disc +17.5 ± 12.7% versus A-P% body -2.5 ± 2.6%; P < 0.001, NM: A-P% disc +19.1 ± 18.0% versus A-P% body -3.5 ± 5.1%; P < 0.001). The A-C% T1-S1 in AIS and NM patients were similar (+7.9 ± 1.8% and +8.7 ± 4.0%, P = 0.273), but differed from the controls (+4.2 ± 3.3%; P < 0.001). CONCLUSIONS: So called anterior overgrowth has been postulated as a possible cause for idiopathic scoliosis, but apparently it occurs in scoliosis with a known origin as well. This suggests that it is part of a more generalized scoliotic mechanism, rather than its cause. The fact that the intervertebral discs contribute more to this increased anterior length than the vertebral bodies suggests an adaptation to altered loading, rather than a primary growth disturbance

Long-term randomised comparison between a carbon fibre cage and the Cloward procedure in the cervical spine

A prospective randomised study. To compare the long-term outcome of anterior cervical decompression and fusion (ACDF) with a cervical intervertebral fusion cage (CIFC) and the Cloward procedure (CP). We have previously shown that the 2 year outcome of ACDF with the CIFC is the same as for the CP. The fusion rate in CIFC group was, however, only 55%, compared to 85% in CP group. The long-term outcome of CIFC is poorly documented. Ninety-five patients with at least 6 months duration of neck pain and radicular arm pain were randomly allocated for ACDF with the CIFC or the CP. Radiographs were obtained at 2 years. Questionnaires about pain, disability (Neck Disability Index, NDI), distress, quality of life and global outcome were obtained from 83 patients (87%) (43 CIFC, 40 CP) at a mean follow-up time of 6 years (range 56–94 months). There were no significant differences in any outcome variable between the two treatments. For both CP and CIFC the pain intensity improved (P<0.0001) whereas the NDI was unchanged at long-term follow-up compared to preoperatively. In the CIFC group patients with a healed fusion had significantly less mean pain (24 mm) and NDI (26%) than patients with pseudarthrosis (42 and 41, respectively). Furthermore, the mean pain and NDI reported by CIFC patients with a healed fusion was significantly less than in healed CP patients (37 and 38, respectively). The long-term outcome is the same for the CIFC and the CP, with similar improvements of pain but with considerable remaining functional disability. However, in the subgroup of patients with healed CIFC the outcome was clearly better than for the non-healed CIFC group, and also clearly better than for the healed CP group. Thus, if the healing problem associated with the CIFC can be solved the results indicate that a better outcome can be expected with the cage than with the CP