The effect of skin tension, needle diameter and insertion velocity on the fracture properties of porcine tissue.

Using metal needles to penetrate skin tissue is common in medical treatments for the delivery of medication or minimally invasive surgery. In most applications the fracture properties of skin tissue is not important as the human surgeon has full control over the needle. Given that robotically controlled surgeries and self applied medical devices have become increasingly popular, a better understanding of the fracture properties and how to mathematically model the fracture process is needed. Experiments measuring the force required to fracture porcine skin tissue were done while varying the applied skin tension, needle insertion speed and needle diameter. The applied skin tension was found to have the greatest influence on the fracture properties, while the insertion speed was found to have a negligible impact. The variance in experimental results was not well explained by the three independent variables alone, suggesting that additional parameters influence the fracture process.

Sliding contact accelerates solute transport into the cartilage surface compared to axial loading.

OBJECTIVE: The objectives of this study were: first, to compare solute uptake driven by sliding to cyclic uniaxial compression. And secondly, to evaluate the role of the superficial region on passive diffusion to determine if mechanical action is merely overcoming the low permeability of the superficial region or exceeding equilibrium capacity of the tissue. DESIGN: Tests were performed on osteochondral plugs under two types of conditions: cyclic loading (sliding vs axial compression) and unloaded passive diffusion (intact vs superficial zone removed). The articular surfaces were exposed to a fluorescent bath and uptake was quantified from the surface to the subchondral bone using fluorescent microscopy. Primary outcome measures were total mass transfer, mass transfer rate, and surface partition factor. RESULTS: Mass transfer was 2.1-fold higher at 0.5 h for sliding compared to uniaxial compression (p = 0.004). This increased to 4.4-fold at 2 h (p = 0.002). Solute transport for both loading conditions at 2 h had reached or exceeded intact passive diffusion at 12 h. Total mass transport and mass transport per hour was higher in samples without the superficial region compared to intact samples at equilibrium. Rate of mass transfer was not declining for samples subject to sliding indicating solute uptake induced by sliding would exceed passive tissue capacity. CONCLUSIONS: These results are the first to quantify solute uptake between two components of joint articulation. The study demonstrates that sliding is a larger driver of solute transport compared to cyclic uniaxial compression. This has implications for cell nutrition, tissue engineering and biochemical signaling.

Genicular artEry embolizatioN in patiEnts with oSteoarthrItiS of the Knee (GENESIS) Using Permanent Microspheres: Interim Analysis.

PURPOSE: Planned interim analysis of GENESIS; a prospective pilot study investigating the role of genicular artery embolization (GAE) in patients with mild to moderate osteoarthritis of the knee using permanent microspheres. METHODS: Thirty-eight patients, median age = 60 (45-83), attended for GAE using 100-300 µm permanent microspheres. All patients had mild to moderate knee OA, resistant to conservative treatments over 6 months. Knee MRI was performed at baseline, and 12 months, enabling semi-quantitative analysis using Whole-Organ Magnetic Resonance Imaging Score (WORMS). Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analogue scale (VAS) (0-100 mm) were completed at baseline, 6 weeks, 3 months (n = 32), and 1-year (n = 16). Adverse events were recorded prospectively. RESULTS: Technical success of accessing and embolizing the target genicular arteries was 84%. Six patients were not embolized: four due to a presumed risk of non-target embolization, and two due to a lack of hyperaemic target. Mean VAS improved from 60 (SD = 20, 95% CI 53-66) at baseline to 36 (SD = 24, 95% CI 28-44) at 3 months (p < 0.001) and 45 (SD = 30, 95% CI 30-60) at 1-year (p < 0.05). All KOOS subscales showed a significant improvement at 6-weeks, 3-months, and 1-year follow-up, except function in daily living, which reached borderline significance (p = 0.06) at 1-year. Four patients experienced mild self-limiting skin discoloration over the embolized territory. One patient experienced a small self-limiting groin haematoma. WORMS scores at 1-year follow-up showed significant improvement in synovitis (p < 0.05). There were no cases of osteonecrosis. CONCLUSION: GAE using permanent microspheres in patients with mild to moderate knee OA is safe, with potential efficacy at early follow-up.

Bone density changes following surgical correction of femoroacetabular impingement deformities.

OBJECTIVE: Femoroacetabular impingement (FAI) involves abnormal hip biomechanics due to deformities and is associated with osteoarthritis. Bone mineral density (BMD) in the acetabulum is higher in subjects with convex femoral (cam) FAI deformities compared to control subjects. The objective of this study was to assess post-operative changes of BMD with and without surgical correction of the cam deformity. DESIGN: Thirteen patients with bilateral cam deformities but unilateral symptoms underwent pre-operative and follow-up computed tomography (CT) scans of both hips. The deformity was surgically removed from the symptomatic hip. BMD was measured in regions of interest (ROI) around the superior acetabulum from CT scans at both time points. The contralateral untreated hip was used as a within-patient control. Changes in BMD were assessed by two-way repeated measures ANOVA (side, time) and paired t-tests. RESULTS: A greater BMD decrease was seen in the treated compared to the untreated hip (P < 0.0018). BMD within the superior acetabulum decreased by 39 mg/cc on the treated side (P < 0.0001) but only 9 mg/cc (P = 0.15) in the untreated contralateral hip. These changes represent 7.1% and 1.7% of the pre-operative BMD on the respective sides. CONCLUSIONS: BMD decreased in the treated hip, suggesting a positive effect of surgical correction in relieving stresses within the hip joint. Longer term follow-up is required to assess the ultimate fate of the articular cartilage within the joint. This study showed that surgical correction of the cam deformity in patients with FAI may alter the pathological biomechanics within the joint.

Femoral subchondral bone properties of patients with cam-type femoroacetabular impingement.

OBJECTIVE: Morphological deformities of the hip, such as femoroacetabular impingement (FAI) may be responsible for up to 80% of hip osteoarthritis. In cam type FAI, the pathomechanism has been attributed to repeated abnormal contact between the femur and the antero-superior acetabular rim, resulting in cartilage and labrum degeneration. Subchondral bone stiffness likely plays a major role in the process, but little is known of the mechanical properties of the cam deformity. The purpose of this study was to determine tissue modulus and the trabecular micro-architecture of the subchondral bone of the cam deformity of patients undergoing resection surgery as well as comparing these parameters to healthy aged matched controls. DESIGN: Twelve osteochondral bone biopsies were obtained from symptomatic FAI patients and ten osteochondral control specimens were harvested from cadaveric femurs. A combination of mechanical testing, micro-CT and finite element (FE) analysis were used to determine tissue modulus, bone volume fraction, trabecular thickness, trabecular and spacing, and trabecular number. RESULTS: The mean tissue modulus of the cam-type FAI deformities (E = 5.4 GPa) was significantly higher than normal controls (E = 2.75 GPa, P = 0.038), but no statistically significant differences were found in bone micro-architectural parameters. CONCLUSIONS: The data suggests that subchondral bone of the cam deformity consists of older secondary mineralized bone. This supports the notion that the cam deformity is a primary malformation with intrinsic biomechanical abnormalities rather than a secondary deformity as part of the degenerative process of the covering cartilage or remodeling due to repeated impingement.

Bone density is higher in cam-type femoroacetabular impingement deformities compared to normal subchondral bone.

OBJECTIVE: Cam-type femoroacetabular impingement (FAI) deformities have been associated with early osteoarthritic degeneration of the hip. Degeneration depends on many factors such as joint morphology and dynamics of motion. Bone mineral density (BMD) appears to be a manifestation of the above, and may be a potentiator. Thus the goal of this study was to assess subchondral BMD of cam deformities in symptomatic and asymptomatic FAI subjects, and to compare to normal controls. METHODS: Subjects undergoing surgical correction of a symptomatic cam-type deformity were recruited ("Surgical"). Asymptomatic volunteers were also recruited and classified as normal ("Control") or having a deformity ("Bump") based on their alpha angle measurement. All subjects (n = 12 per group) underwent computed tomography (CT) with a calibration phantom. BMD was determined in volumes of interest around the femoral head and neck to a depth of 5 mm. BMD was compared between groups in each section using spine BMD as a covariate. RESULTS: No differences were seen between groups in the peripheral bearing surface. The Bump group exhibited higher BMD than Controls within the head/neck junction (P < 0.05). When compared to normal subchondral bone in the peripheral level of Controls, BMD in the deformity was up to 78% higher in Bump subjects and up to 47% higher in Surgical subjects (P < 0.05). CONCLUSION: Subchondral BMD of cam deformities is higher than that of normal subchondral bone in the peripheral region of the femoral head, regardless of symptom status. The expected increased subchondral stiffness may increase contact stresses in the joint tissues leading to accelerated degeneration.

Increased acetabular subchondral bone density is associated with cam-type femoroacetabular impingement.

OBJECTIVE: Femoroacetabular impingement (FAI) has been associated with significant acetabular cartilage damage and subsequent degenerative arthritis. Subchondral bone, often neglected in osteoarthritis studies, may play an important role in the degenerative cascade. Hence the goal of this study was to assess acetabular subchondral bone mineral density (BMD) in subjects with asymptomatic or symptomatic cam deformities compared to normal control subjects. The relationship between BMD and the alpha angle, a quantitative measure of the deformity, was also analyzed. METHODS: Patients diagnosed with symptomatic cam FAI were recruited ('Surgical') as well as subjects from the general asymptomatic population, classified from CT imaging as normal ('Control') or having a cam deformity ('Bump') based on their alpha angle measurement. There were 12 subjects in each group. All subjects underwent a CT scan with a calibration phantom. BMD was calculated in regions of interest around the acetabulum from CT image intensity and the phantom calibration. BMD was compared between groups using spine BMD as a covariate. The relationship between BMD and alpha angle was assessed by linear regression. RESULTS: In the antero-superior regions bone density was 15-34% higher in the Bump group (P < 0.05) and 14-38% higher in the Surgical group (P < 0.05) compared to Controls. BMD correlated positively with the alpha angle measurements (R(2) = 0.44, P < 0.001). CONCLUSION: BMD was elevated in subjects with cam-type deformities, with the severity of the deformity more correlative than symptom status. Similarities to the symptomatic group suggest that hips with an asymptomatic deformity may already be in early stages of joint degeneration.

Fixation of trochanteric slide osteotomies: a biomechanical study.

OBJECTIVE: (1) Determine the effect of a compressive force on the stability of trochanteric slide osteotomies repaired with a cable repair system or a suturing technique. (2) Develop an approach to surgical decision making for trochanteric repair. DESIGN: Muscle forces acting on the greater trochanter were experimentally modeled by the application of shear and compressive loads to osteotomized greater trochanters. A repeated measures design was used to compare suture and cable fixation. BACKGROUND: The use of cables and wires for trochanteric repair has been associated with a high incidence of acetabular loosening and trochanteric bursitis. With trochanteric slide osteotomies, the vastus lateralis remains attached to the trochanter, which results in a compressive force being generated across the osteotomy and relatively small shear forces. The use of less rigid fixation techniques for trochanteric repair, such as sutures, may reduce the complications of cables and wires. METHODS: Seven cadaveric femora with trochanteric osteotomies were tested sequentially after repair with a cable system and with a suturing technique. A cyclic shear load of constant amplitude was applied while a compressive load was decreased in a stepwise fashion. Migration and cyclic motion of the trochanter were measured, and the coefficient of friction was also determined. RESULTS: Cyclic motions of the trochanter in both superior and anterior directions were generally less than 0.5 mm and were not significantly different between the cables and sutures at high compressive loads. At low compressive loads, cyclic motion was significantly lower with the cable system. CONCLUSIONS: Compression across the trochanteric slide osteotomy has a significant effect on stability. Cyclic motion of the trochanter is similar for both suture or cable repair of a trochanteric slide with good preservation of soft tissue attachments. RELEVANCE: Based on theoretical and experimental evidence, repair of trochanteric slide osteotomies with a suture technique may be a viable alternative to the use of cables and wires in selected cases.

Three-dimensional metacarpophalangeal joint kinematics using two markers on the phalanx.

A protocol for analysing three-dimensional metacarpophalangeal (MCP) joint motion in vivo using two markers on the proximal phalanx is described. The analysis uses an assumption that the rotation of the phalanx about its own long axis is zero. In an experimental study 24 volunteers had surface markers applied to the dorsal surfaces of their hands and index and long finger proximal phalanges, with three-dimensional marker positions recorded in two hand and finger postures in an incomplete box design using a test-retest protocol. Kinematic parameters from the optoelectronic system were compared with those obtained from three-dimensional reconstruction of bone landmarks and of the marker positions identified on stereoradiographs. Pronation/supination angles obtained from bone landmarks showed high test-retest variability, reflecting the difficulty in obtaining reliable pronation/supination data in small bones without the use of implanted markers. Changes in MCP joint extension and deviation angles determined using two surface markers agree with those obtained from bone landmarks. The results indicate a reproducible protocol for tracking MCP joint motion using only two phalangeal markers, suggesting that the 'no-rotation assumption' can be applied without affecting measures of extension and deviation motion in the normal joint.

A randomised, double-blind, placebo-controlled, comparative study of topical skin analgesics and the anxiety and discomfort associated with venous cannulation.

OBJECTIVES: To compare the effect of topical skin anaesthetic agents on the discomfort and anxiety associated with venous cannulation. DESIGN: Randomised, double-blind, placebo-controlled, within subject, volunteer trial. METHODS: 20 healthy volunteers underwent venous cannulation on three separate occasions having received topical skin application of either 4% amethocaine gel (Ametop), 5% eutectic mixture of lidocaine and prilocaine (EMLA) or E45 cream (placebo). Visual analogue and verbal rating scales were used to assess pain and anxiety associated with the venous cannulation, and anticipated anxiety for future cannulation, under each drug condition. RESULTS: Subjects were aged 22-53 years (mean 32.8 years). The mean visual analogue scores (VAS) for discomfort were found to be significantly lower (p< 0.001) with Ametop (VAS = 18mm) and EMLA (VAS = 29mm) compared with the control (VAS = 38mm). There was a positive correlation (R2 = 72%, p<0.001) between discomfort and the predicted anxiety if cannulation was to be repeated with the same cream. With the placebo a positive correlation (R2 = 19.8%, p = 0.05) was found between the level of anxiety before cannulation and the level of discomfort recorded. CONCLUSIONS: Ametop and EMLA topical anaesthetic agents produce effective skin analgesia for venous cannulation. The use of topical analgesia can reduce perceived anxiety about future cannulation procedures. This has application in the management of anxious patients undergoing intravenous sedation, suggesting that topical analgesia prior to venous cannulation may significantly aid anxiolysis.

Three-dimensional measurement of cemented femoral stem stability: an in vitro cadaver study.

OBJECTIVE: To compare the in vitro stability of two cemented hip stem designs: Stem I was a collarless, double-tapered, highly polished implant; Stem II had a collar and matt finish. BACKGROUND: Stability of the femoral component of a hip implant is important for its long-term clinical success. Excessive migration or cyclic motion can increase the risk of early implant failure. METHODS: The stems were implanted in paired human cadaver femurs, and custom-designed micromotion sensors were used to measure three-dimensional motions of the stems at proximal, middle and distal locations during simulated in vivo loading cycles. RESULTS: This study found that despite 'rigid' fixation, cemented stems exhibit detectable motions under a limited number of cycles of simulated physiologic loads. At four times the donor body weight, Stem I showed a subsidence of 90 microm, compared to 25 microm of Stem II (P<0.05). In contrast, the proximal end of Stem II exhibited greater cyclic motions in the medial-lateral direction (P<0.05). CONCLUSIONS: The different motion patterns could be due to the design differences, such as surface finish and geometry. RelevanceImplant design is an important factor related to the behavior of the cement/bone interface and the overall success of the implant. This study compares in vitro micromotion of two cemented femoral prostheses with differing proximal designs.

Incidence of cancer in children born after in-vitro fertilization.

Evaluation of the long-term health of children born using in-vitro fertilization (IVF) provides important information to clinicians and consumers. Until very recently, there have been no published data on the incidence of cancer in children conceived as a result of IVF, despite a number of case reports of neuroblastoma in children conceived using fertility drugs. This study used a record-linkage cohort design to investigate the incidence of cancer in children born after IVF. The study included all conceptions using assisted reproductive technologies between 1979 and 1995 at two clinics in Victoria, Australia that resulted in a live birth. Data on births were linked with a population-based cancer registry to determine the number of cases of cancer that occurred. The standardized incidence ratio (SIR) was calculated by comparing the observed number of cases to the expected number of cases. The final cohort included 5249 births. The median length of follow-up was 3 years, 9 months (range 0-15 years). In all, 4.33 cases of cancer were expected and six were observed, giving a SIR of 1.39 (95% CI 0.62-3.09). This study found that children conceived using IVF and related procedures did not have a significantly increased incidence of cancer in comparison to the general population.

A quantitative analysis of the impact of cryopreservation on the implantation potential of human early cleavage stage embryos.

The impact of cryopreservation on the implantation potential of early cleavage stage (day 2) embryos was assessed by analysing the outcome from > 5000 thawed embryos in relation to the outcome from a similar number of fresh embryos. Analysis of procedures in which all transferred embryos fulfilled equivalent defined criteria revealed no significant difference in the implantation rates (fetal hearts/100 embryos transferred) of fresh 4-cell embryos (16.6%) and fully intact thawed 4-cell embryos (16.9%). Although 2-cell embryos implanted at significantly lower rates, there was again no significant difference between fresh (6.5%) and fully intact thawed (7.2%) embryos. Similar analysis of all embryos (irrespective of cell number on day 2) demonstrated that the implantation potential of partially intact thawed embryos was related to the extent of blastomere loss with the implantation rate of embryos with 50% cell survival (5.4%) being approximately half the rate of fully intact embryos (11.3%). Combining the values obtained from 'pure' data for the implantation rates of embryos with defined levels of survival with their relative prevalence in the total population of thawed embryos gave a predicted number of implantations (441) which was similar to the observed outcome (463). This number was approximately 30% less than the number expected had the same embryos been transferred fresh (635). The results suggest that intact thawed embryos have the same implantation potential as equivalent fresh embryos and that the impact of cryopreservation is limited to blastomere loss which is directly related to loss of implantation potential. The observed frequency of blastomere loss results in a reduction of approximately 30% in the implantation potential of a population of embryos following cryopreservation.

Biomechanical properties of sterilized human auditory ossicles.

Bone allograft material is treated with sterilization methods to prevent the transmission of diseases from the donor to the recipient. The effect of some of these treatments on the integrity of the bone is unknown. This study was performed to evaluate the effect of several sterilization methods on the mechanical behaviour of human middle ear bones. Due to the size and composition of the bones (approximately 1.5 mm diameter by 4 mm long), mechanical testing options were limited to the traditional platens compression test. Experiments were first performed with synthetic bone to evaluate the precision of this test applied to small specimens. Following this, fresh frozen human ossicles were thawed and sterilized with (i) 1 N NaOH (n = 12); (ii) 0.9% LpH, a phenolic solution (n = 12); or (iii) steam at 134 degrees C (n = 18). A group of 26 control specimens did not receive any sterilization treatment. Material and structural properties were determined from axial compression testing. Results from the synthetic bone showed that the test was reproducible, with standard deviations less than 20% of the means. Significant differences occurred in stiffness and ultimate force values between NaOH-treated and autoclaved bones when compared to normals (p<0.05), but not for LpH-treated bones. LpH is not approved for medical use, so NaOH is the most appropriate of the treatments studied for the sterilization of ossicle allografts.

Radiologic and mechanical properties of inactivated ossicle homografts.

OBJECTIVE: This study examined the effects of old and new inactivation (sterilization) techniques on the radiologic and mechanical properties of ossicle homografts. MATERIALS AND METHODS: Ninety normal incuses and malleuses received either treatment with 1) 5% formaldehyde/cialit, 2) 1N NaOH, 3) 0.9% LpH, or 4) autoclaving at 134'C, or no treatment. All ossicles were assessed radiologically by high-resolution computed tomography. After imaging, all ossicles underwent mechanical testing by destructive axial compression in a mechanical testing machine measuring force and displacement. RESULTS: Ossicles treated with cialit, NaOH, or autoclaving showed a significant decrease of ultimate force and stiffness compared with controls. LpH treatment caused no such changes in these structural properties. Material properties of yield strength, ultimate strength, and elastic modulus were also altered by cialit, NaOH, and autoclaving, but were much more difficult to assess because of uncertainty in parameter estimates. There was a significant increase in radiologic density in autoclaved ossicles, a reduction in cialit- and LpH-treated ossicles, and no change in NaOH-treated ossicles. CONCLUSIONS: All tested inactivation procedures changed the biomechanical and/or radiologic properties of ossicle homografts. However, the new procedures used to inactivate infectious agents produced changes similar to the older treatments with formaldehyde/cialit. Human allografts are able to withstand harsh but safe sterilization procedures. The NaOH treatment seems to be the most suitable method for the future. The biologic (osteogenic) potentials of ossicle homografts treated with these new preservation/inactivation methods are still unknown. Further investigations are necessary to re-evaluate the clinical use of ossicle homografts in middle ear reconstructive surgery.

Antibodies to beta2 glycoprotein I are associated with in vitro fertilization implantation failure as well as recurrent miscarriage: results of a prevalence study.

OBJECTIVE: To investigate whether antiphospholipid and related autoantibodies are associated with IVF implantation failure as well as with recurrent spontaneous miscarriage. DESIGN: Prevalence study. SETTING: University teaching hospital and associated IVF unit. PATIENT(S): Patients with at least three consecutive first-trimester miscarriages (n = 97), patients undergoing IVF who had at least 10 embryos transferred without any resulting clinical pregnancy (n = 105), fertile women (n = 106), and patients newly referred for IVF treatment (n = 52). INTERVENTION(S): Antibodies tested included lupus anticoagulant; immunoglobulin (Ig) G and IgM isotypes of each of anticardiolipin antibody, antiphosphatidylserine, antiphosphatidylethanolamine, and antiphosphatidylinositol; beta2 glycoprotein I antibodies; and antinuclear antibodies. Statistical analysis included chi2 and Fisher's exact tests for differences between groups, and multiple linear regression analysis and Spearman's nonparametric tests for relations between results. MAIN OUTCOME MEASURE(S): Seropositivity for autoantibodies tested. RESULT(S): Overall, 84 (23%) of the 360 samples tested positive for at least one autoantibody. Beta2 glycoprotein I IgM antibody and antinuclear antibody were significantly associated with both IVF implantation failure and recurrent miscarriage. CONCLUSION(S): Autoantibodies, particularly beta2 glycoprotein I antibodies and antinuclear antibodies, are associated with IVF implantation failure as well as with recurrent spontaneous abortion, although the mechanism is still unclear. The high seroprevalence of antibodies to beta2 glycoprotein I suggests that it may have an important role in autoimmune reproductive failure that needs to be explored further.