Erik I. Waldorff

Characterization of carbon nanotubes produced by arc discharge: Effect of the background pressure

Single walled carbon nanotubes (SWNT) produced by the anodic arc discharge over a range of constant background pressures of helium (100–1000 Torr) were examined under a high-resolution transmission electron microscope, and a Raman spectrometer. It was found that the average SWNT diameter is about 2 nm and fairly independent of the background pressure. Analysis of the relative purity of SWNTs samples suggests that highest SWNT relative concentration can be obtained at background pressure of about 200–300 Torr. Measured anode ablation rate increases linearly with background pressure. The model of the anodic arc discharge was developed. It was found that the predicted anode ablation rate agrees well with experiment suggesting that electron temperature in the anodic arc is about 0.5 eV.

Microdamage Repair and Remodeling Requires Mechanical Loading

Bone remodeling is necessary to avoid microdamage accumulation, which could lead to whole‐bone failure. Previous studies have shown that this bone‐repair mechanism is triggered by osteocyte apoptosis. Through the use of a rodent hindlimb suspension model and tibial four‐point bending model, the effects of disuse on microdamage remodeling was examined. At day 0, male rats were assigned to one of three groups: weight bearing (WB), hindlimb suspension (HS), or hindlimb suspension with daily intermittent weight bearing following damage‐inducing loading (HW). Within each group, the rats were further divided into subgroups corresponding to three sacrifice time points [day 14 (WB and HS only), day 18, or day 35]. At day 14, animals were anesthetized, and their left tibiae underwent cyclic four‐point bending to produce fatigue‐induced microdamage. At sacrifice, the tibiae were examined using 3D micro‐computed tomography (µCT), flow cytometry, and histologic and immunohistochemical stains. The results indicate that only the WB and HW groups had a significant increase in intracortical TRAP‐positive resorption pits following damage induction, which was paralleled by a significant decrease in microdamage over time in combination with a shift in the osteoclast lineage owing to a decrease in monocytes. These results demonstrate that osteocyte apoptosis may be insufficient for repair of microdamage without the stimulation provided through physiologic loading. In addition, this potentially could have clinical implications for the current therapeutic paradigm for treating stress fractures, where extended non‐weight bearing is employed.

Bone density of the greater tuberosity is decreased in rotator cuff disease with and without full-thickness tears

BACKGROUNDnDespite the high prevalence of rotator cuff disease in the aging adult population, the basic mechanisms initiating the disease are not known. It is known that changes occur at both the bone and tendon after rotator cuff tears. However, no study has focused on early or pretear rotator cuff disease states. The purpose of this study was to compare the bone mineral density of the greater tuberosity in normal subjects with that in subjects with impingement syndrome and full-thickness rotator cuff tears.nnnMATERIALS AND METHODSnDigital anteroposterior shoulder radiographs were obtained for 3 sex- and age-matched study groups (men, 40-70 years old): normal asymptomatic shoulders (control), rotator cuff disease without full-thickness tears (impingement), and full-thickness rotator cuff tears (n = 39 per group). By use of imaging software, bone mineral densities were determined for the greater tuberosity, the greater tuberosity cortex, the greater tuberosity subcortex, and the cancellous region of the humeral head.nnnRESULTSnThe bone mineral density of the greater tuberosity was significantly higher for the normal control subjects compared with subjects with impingement or rotator cuff tears. No differences were found between the two groups of patients with known rotator cuff disease. The greater tuberosity cortex and greater tuberosity subcortex outcome measures were similar.nnnCONCLUSIONnBone mineral changes are present in the greater tuberosity of shoulders with rotator cuff disease both with and without full-thickness tears. The finding of focal diminished bone mineral density of the greater tuberosity in the absence of rotator cuff tears warrants further investigation.

Effects of pulsed electromagnetic field therapy at different frequencies and durations on rotator cuff tendon-to-bone healing in a rat model

BACKGROUNDnRotator cuff tears affect millions of individuals each year, often requiring surgical intervention. However, repair failure remains common. We have previously shown that pulsed electromagnetic field (PEMF) therapy improved tendon-to-bone healing in a rat rotator cuff model. The purpose of this study was to determine the influence of both PEMF frequency and exposure time on rotator cuff healing.nnnMETHODSnTwo hundred ten Sprague-Dawley rats underwent acute bilateral supraspinatus injury and repair followed by either Physio-Stim PEMF or high-frequency PEMF therapy for 1, 3, or 6 hours daily. Control animals did not receive PEMF therapy. Mechanical and histologic properties were assessed at 4, 8, and 16 weeks.nnnRESULTSnImprovements in different mechanical properties at various endpoints were identified for all treatment modalities when compared with untreated animals, regardless of PEMF frequency or duration. Of note, 1 hour of Physio-Stim treatment showed significant improvements in tendon mechanical properties across all time points, including increases in both modulus and stiffness as early as 4 weeks. Collagen organization improved for several of the treatment groups compared with controls. In addition, improvements in type I collagen and fibronectin expression were identified with PEMF treatment. An important finding was that no adverse effects were identified in any mechanical or histologic property.nnnCONCLUSIONSnOverall, our results suggest that PEMF therapy has a positive effect on rat rotator cuff healing for each electromagnetic fundamental pulse frequency and treatment duration tested in this study.

Pulsed electromagnetic field therapy improves tendon‐to‐bone healing in a rat rotator cuff repair model

Rotator cuff tears are common musculoskeletal injuries often requiring surgical intervention with high failure rates. Currently, pulsed electromagnetic fields (PEMFs) are used for treatment of long‐bone fracture and lumbar and cervical spine fusion surgery. Clinical studies examining the effects of PEMF on soft tissue healing show promising results. Therefore, we investigated the role of PEMF on rotator cuff healing using a rat rotator cuff repair model. We hypothesized that PEMF exposure following rotator cuff repair would improve tendon mechanical properties, tissue morphology, and alter in vivo joint function. Seventy adult male Sprague–Dawley rats were assigned to three groups: bilateral repair with PEMF (nu2009=u200930), bilateral repair followed by cage activity (nu2009=u200930), and uninjured control with cage activity (nu2009=u200910). Rats in the surgical groups were sacrificed at 4, 8, and 16 weeks. Control group was sacrificed at 8 weeks. Passive joint mechanics and gait analysis were assessed over time. Biomechanical analysis and μCT was performed on left shoulders; histological analysis on right shoulders. Results indicate no differences in passive joint mechanics and ambulation. At 4 weeks the PEMF group had decreased cross‐sectional area and increased modulus and maximum stress. At 8 weeks the PEMF group had increased modulus and more rounded cells in the midsubstance. At 16 weeks the PEMF group had improved bone quality. Therefore, results indicate that PEMF improves early tendon healing and does not alter joint function in a rat rotator cuff repair model.

Preclinical evaluation of a novel implant for treatment of a full-thickness distal femoral focal cartilage defect.

A novel, nonresorbable, monolithic composite structure ceramic, developed using a partially stabilized zirconia ceramic common to implantable devices, was used in a cementless weight-bearing articular implant to test the feasibility of replacing a region of degenerated or damaged articular cartilage in the knee as part of a preclinical study using male mongrel dogs lasting up to 24 weeks. Gross/histological cartilage observations showed no differences among control, 12-week and 24-week groups, while pull-out tests showed an increase in maximum pull-out load over time relative to controls. Hence, the use of a novel ceramic implant as a replacement for a focal cartilage defect leads to effective implant fixation within 12 weeks and does not cause significant degradation in opposing articular cartilage in the time frame evaluated.

Evaluation of a polyetheretherketone (PEEK) titanium composite interbody spacer in an ovine lumbar interbody fusion model: biomechanical, microcomputed tomographic, and histologic analyses

BACKGROUND CONTEXTnThe most commonly used materials used for interbody cages are titanium metal and polymer polyetheretherketone (PEEK). Both of these materials have demonstrated good biocompatibility. A major disadvantage associated with solid titanium cages is their radiopacity, limiting the postoperative monitoring of spinal fusion via standard imaging modalities. However, PEEK is radiolucent, allowing for a temporal assessment of the fusion mass by clinicians. On the other hand, PEEK is hydrophobic, which can limit bony ingrowth. Although both PEEK and titanium have demonstrated clinical success in obtaining a solid spinal fusion, innovations are being developed to improve fusion rates and to create stronger constructs using hybrid additive manufacturing approaches by incorporating both materials into a single interbody device.nnnPURPOSEnThe purpose of this study was to examine the interbody fusion characteristic of a PEEK Titanium Composite (PTC) cage for use in lumbar fusion.nnnSTUDY DESIGN/SETTINGnThirty-four mature female sheep underwent two-level (L2-L3 and L4-L5) interbody fusion using either a PEEK or a PTC cage (one of each per animal). Animals were sacrificed at 0, 8, 12, and 18 weeks post surgery.nnnMATERIALS AND METHODSnPost sacrifice, each surgically treated functional spinal unit underwent non-destructive kinematic testing, microcomputed tomography scanning, and histomorphometric analyses.nnnRESULTSnRelative to the standard PEEK cages, the PTC constructs demonstrated significant reductions in ranges of motion and a significant increase in stiffness. These biomechanical findings were reinforced by the presence of significantly more bone at the fusion site as well as ingrowth into the porous end plates.nnnCONCLUSIONSnOverall, the results indicate that PTC interbody devices could potentially lead to a more robust intervertebral fusion relative to a standard PEEK device in a clinical setting.

Pulsed electromagnetic field applications: A corporate perspective

Summary Corporate establishment of US Food & Drug Administration approved pulsed electromagnetic fields (PEMFs) for clinical applications has been achieved. However, optimization of PEMFs for improvement in efficacy for current indications, in addition to the expansion into new indications, is not trivial. Moving directly into a clinical trial can be costly and carries little guarantee for success, necessitating the need for preclinical studies as supported by this review of the extensive corporate preclinical experience by Orthofix, Inc. The Translational Potential of this Article: This review illustrates the need to gain enough in vitro/in vivo knowledge of specific PEMF signals and its target tissue interaction to enable a high success rate in clinical trials.

PEEK Titanium Composite (PTC) for Spinal Implants

Since the development of the posterior lumbar interbody fusion (PLIF) and anterior approach for anterior cervical discectomy and fusion (ACDF) many different fusion substrates such as grafts and devices, have been explored. This includes autografts, allografts, and interbody spacers made from polyether-ether-ketone (PEEK), porous tantalum and titanium.In an attempt to combine only the advantages from both the PEEK and titanium interbody devices, a novel type of PEEK titanium composite (PTC) interbody fusion device has been developed. This device combines a PEEK core with titanium alloy endplates made from a novel 3-dimensional (3D) titanium mesh (Ti6Al4V) to potentially enable a better bone apposition and ingrowth while enabling imaging of the fusion site.This chapter covers how the novel PTC interbody devices are manufactured, which applications the PTC technology have currently been applied to, and how the mechanical properties of the interbody devices that employ the PTC technology compare to that of standard PEEK devices. In addition, the surface topography of the Ti6Al4V endplates will be discussed alongside a presentation of several in vitro and in vivo studies that have been completed for the PTC technology. Specifically, two in vitro studies will be presented showing the effect of each of the structural components (PEEK, Ti6Al4V) on the proliferation and differentiation of immature and mature osteoblasts. Furthermore, two in vivo studies will illustrate the effect of the structural components (PEEK, Ti6Al4V) on bone ingrowth/ongrowth and biocompatibility in a rabbit model, and the effect of a clinical PTC device in an ovine lumbar fusion model. Lastly, a discussion will summarize the presented studies and make the case for the PTC technology as a new standard for interbody devices in spine fusion.

Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution® Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion

BackgroundTrinity Evolution® (TE), a viable cellular bone allograft, previously demonstrated high fusion rates and no safety-related concerns after single-level anterior cervical discectomy and fusion (ACDF) procedures. This prospective multicenter clinical study was performed to assess the radiographic and clinical outcomes of TE in subjects undergoing two-level ACDF procedures.MethodsIn a prospective, multicenter study, 40 subjects that presented with symptomatic cervical degeneration at two adjacent vertebral levels underwent instrumented ACDF using TE autograft substitute in a polyetherethereketone (PEEK) cage. At 12xa0months, radiographic fusion status was evaluated by dynamic motion plain radiographs and thin cut CT with multiplanar reconstruction by a panel that was blinded to clinical outcome. Fusion success was defined by angular motion (≤4°) and the presence of bridging bone across the adjacent vertebral endplates. Clinical pain and function assessments included the Neck Disability Index (NDI), neck and arm pain as evaluated by visual analog scales (VAS), and SF-36 at both 6 and 12xa0months.ResultsAt both 6 and 12xa0months, all clinical outcome scores (SF-36, NDI, and VAS pain) improved significantly (pu2009<u20090.05) compared to baseline values. There were no adverse events or infections that were attributed to the graft material, no subjects that required revisions, and no significant decreases to mean neurological evaluations at any time as compared to baseline. At 12xa0months, the per subject and per level fusion rate was 89.4 and 93.4%, respectively. Subgroup analysis of subjects with risk factors for pseudoarthrosis (current or former smokers, diabetic, or obese/extremely obese) compared to those without risk factors demonstrated no significant differences in fusion rates.ConclusionsPatients undergoing two-level ACDF with TE in combination with a PEEK interbody spacer and supplemental anterior fixation had a high rate of fusion success without any serious adverse events related to the graft material.Trial registrationTrinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF) NCT00951938