Basivertebral nerve ablation for the treatment of chronic low back pain in a community practice setting: 6 Months follow-up.

BACKGROUND: Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the clinical outcomes for 16 consecutively treated patients in a community practice setting. METHODS: Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, and 6 months. The Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 were recorded in Medrio electronic data capture software. All patients ( RESULTS: The ODI, VAS, and SF-36 Pain Component Summary showed statistically significant improvements above minimal clinically important differences at 1 month, 3 months, and 6 months (all p values CONCLUSIONS: Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation

Supplemental Fixation of Inner Graft Limbs in All-Inside, Quadrupled, Single-Tendon Anterior Cruciate Ligament Reconstruction Graft Construct Yields Improved Biomechanical Properties

To compare the time-zero load to failure of a quadrupled, single-tendon, all-inside anterior cruciate ligament (ACL) reconstruction graft construct with (supplemented) and without the incorporation of inner-limb whipstitch sutures (control) into a tibial suspensory fixation button. Eight matched pairs of peroneus longus tendons were prepared according to a quadrupled, all-inside ACL soft-tissue graft technique with 1 side serving as a control and the contralateral side supplemented. The constructs were biomechanically tested for strain in the inner and outer limbs during a preconditioning protocol, single-cycle load to failure, and elongation of the whole construct. Ultimate load to failure was significantly higher in the supplemented group: 797.5 ± 49.6 N (95% confidence interval [CI], 763.13-831.87 N) versus 719.6 ± 69.6 N (95% CI, 671.38-767.82 N; P = .044). Less graft elongation at failure was observed in the supplemented group (3.1 ± 1.5 mm; 95% CI, 2.07-4.17 mm) versus the control group (21.0 ± 21.2 mm; 95% CI, 6.31-35.69 mm; P = .052). The number of grafts undergoing a 5-mm or greater change in length at failure was 1 of 8 in the supplemented group versus 5 of 8 in the control group (P = .038). Inner-limb supplemental tibial fixation results in higher time-zero load to failure and decreased graft elongation in a quadrupled, single-tendon, all-inside ACL reconstruction graft construct. The weak point of a single-tendon, quadrupled, all-inside ACL graft construct is the tendon-to-tendon suturing to secure the inner limbs of the graft. Adding supplemental fixation by incorporating the sutures from the inner limb to the tibial suspensory fixation button leads to a higher time-zero load to failure and decreased graft elongation

Histologic, Biomechanical, and Biological Evaluation of Fan-Folded Iliotibial Band Allografts for Anterior Cruciate Ligament Reconstruction

The purpose of this study was to thoroughly characterize the fan-folded iliotibial band (FITB) allograft and compare it with anterior tibialis tendons (ATs) and native anterior cruciate ligaments (ACLs) to determine whether it measures up to those tissues. We compared the histologic structure, tensile strength to failure, creep, and stress-relaxation properties of FITBs with those of ATs and ACLs. In vitro cytotoxicity and biocompatibility of FITBs were also compared with ATs. No structural difference was observed between the tissues studied. FITB ultimate tensile strength (3,459 ± 939 N) was not significantly different (P > .9999) from ultimate tensile strength of ATs (3,357 ± 111 N) and was significantly greater (P = .0005) than that of ACLs (886 ± 254 N). No significant difference (P > .9999) was observed in the increase in length resulting from creep testing between FITBs (9.5 ± 3.0 mm) and ATs (9.7 ± 4.0 mm). During stress-relaxation testing, FITBs reached 181 ± 46 N, which was not significantly different (P > .9999) from ATs (166 ± 40 N). Finally, we showed that cytotoxicity of FITBs and ATs was negligible. In vitro biocompatibility of FITBs and ATs was very good, whereas FITBs had a higher propensity to favor the attachment and infiltration of cells that proliferated for at least 4 weeks on their contact. We found that FITBs, ACLs, and ATs shared a similar structure made of aligned collagen fibers. No significant difference was observed between FITB and AT ultimate tensile strength, creep, and stress-relaxation viscoelastic properties. Ultimate tensile strength to failure of ACLs was lower than that of FITBs and ATs, whereas ACLs were superior to both FITBs and ATs during creep and stress-relaxation testing. FITBs and ATs showed low cytotoxicity and excellent biocompatibility in vitro, with a somewhat higher propensity of FITBs to favor cell attachment and infiltration over time. This study suggests that FITBs have the potential to perform as well as ATs for ACL reconstruction

Human Bone Marrow-Derived Mesenchymal Stromal Cell-Seeded Bone Biomaterial Directs Fast and Superior Mandibular Bone Augmentation in Rats

Atrophic maxillary ridges present a challenge in the field of oral implantology. Autologous bone is still considered the gold standard grafting material, but the increased morbidity and surgical complications represent a major drawback for its use. The aim of this study was to assess the efficacy of an off-the-shelf cell-seeded bone biomaterial for mandibular bone augmentation, compared to its acellular counterpart. We used a rat model to test the osteogenic properties of bone marrow-derived mesenchymal stromal cells (MSCs)-seeded bone microparticles compared to acellular bone microparticles alone. Rats were euthanized at 4 and 8 weeks, and results analyzed using micro-CT imaging, histology (H&E, Masson’s Trichrome), histomorphometry and immunohistology (Tartrate-Resistant Acid Phosphatase-TRAP, Osteocalcin and human specific anti-mitochondria antibodies). Micro-CT analysis demonstrated that the cell-seeded biomaterial achieved significantly more bone volume formation at 4 weeks (22.75 ± 2.25 mm 3 vs 12.34 ± 2.91 mm 3 , p = 0.016) and at 8 weeks (64.95 ± 5.41 mm 3 vs 42.73 ± 10.58 mm 3 , p = 0.029), compared to the acellular bone microparticles. Histology confirmed that the cell-seeded biomaterial was almost completely substituted at 8 weeks, in opposition to the acellular biomaterial group. Immunohistochemical analysis showed a significantly higher number of TRAP and Osteocalcin positive cells at 4 weeks in the cell-seeded group compared to the acellular group, thereby demonstrating a higher rate of bone remodeling in the presence of MSCs. The grafted human cells remained viable and were detected up to at least 8 weeks, as observed using the human specific anti-mitochondria antibody. This off-the-shelf material available in unlimited quantities could therefore represent a significant advance in the field of mandibular bone augmentation by providing a larger volume of new bone formation in a shorter time

Pharmacologically active microcarriers delivering BDNF within a hydrogel: Novel strategy for human bone marrow-derived stem cells neural/neuronal differentiation guidance and therapeutic secretome enhancement.

Stem cells combined with biodegradable injectable scaffolds releasing growth factors hold great promises in regenerative medicine, particularly in the treatment of neurological disorders. We here integrated human marrow-isolated adult multilineage-inducible (MIAMI) stem cells and pharmacologically active microcarriers (PAMs) into an injectable non-toxic silanized-hydroxypropyl methylcellulose (Si-HPMC) hydrogel. The goal is to obtain an injectable non-toxic cell and growth factor delivery device. It should direct the survival and/or neuronal differentiation of the grafted cells, to safely transplant them in the central nervous system, and enhance their tissue repair properties. A model protein was used to optimize the nanoprecipitation conditions of the neuroprotective brain-derived neurotrophic factor (BDNF). BDNF nanoprecipitate was encapsulated in fibronectin-coated (FN) PAMs and the in vitro release profile evaluated. It showed a prolonged, bi-phasic, release of bioactive BDNF, without burst effect. We demonstrated that PAMs and the Si-HPMC hydrogel increased the expression of neural/neuronal differentiation markers of MIAMI cells after 1week. Moreover, the 3D environment (PAMs or hydrogel) increased MIAMI cells secretion of growth factors (b-NGF, SCF, HGF, LIF, PlGF-1, SDF-1α, VEGF-A & D) and chemokines (MIP-1α & β, RANTES, IL-8). These results show that PAMs delivering BDNF combined with Si-HPMC hydrogel represent a useful novel local delivery tool in the context of neurological disorders. It not only provides neuroprotective BDNF but also bone marrow-derived stem cells that benefit from that environment by displaying neural commitment and an improved neuroprotective/reparative secretome. It provides preliminary evidence of a promising pro-angiogenic, neuroprotective and axonal growth-promoting device for the nervous system