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Muscle, bone and tendon regeneration depend on the microperfusion of the corresponding tissue which can be quantified with contrast-enhanced ultrasound (CEUS) using sulfur hexafluoride contrast agent (SonoVue ). This study investigated the incidence of adverse events (AEs) in musculoskeletal patients and gives an overview of musculoskeletal CEUS applications. Based on 13 studies in a standardized monocentric setting, a total of 2268 CEUS examinations in 764 patients were performed and AEs due to the administration of sulfur hexafluoride contrast agent were classified as either mild, moderate or severe. No fatal events occurred. AEs were reported in three cases, of which only one was classified as severe and two as mild. The total rate of all AEs was 0.13% and 0.04% for severe AEs. The present analysis confirms the safety of musculoskeletal CEUS using sulfur hexafluoride contrast agent with a lower rate of AEs than that reported for other contrast agents even in elderly patients with concomitant diseases.

Background Ankle fractures are common fractures in trauma surgery. Several studies have compared gait patterns between affected patients and control groups. However, no one used the Heidelberg Foot Measurement Method in combination with statistical parametric mapping of the entire gait cycle in this patient cohort. We sought to identify possible mobility deficits in the tibio-talar joint and medial arch in patients after ankle fractures as a sign of stiffness and pain that could result in a pathological gait pattern. We focused on the tibio-talar flexion as it is the main movement in the tibio-talar joint. Moreover, we examined the healing progress over time. Methods Fourteen patients with isolated ankle fractures were included prospectively. A gait analysis using the Heidelberg Foot Measurement Method was performed 9 and 26 weeks after surgery to analyse the tibio-talar dorsal flexion, the foot tibia dorsal flexion, the subtalar inversion and the medial arch as well as the cadence, the walking speed and the ground reaction force. The American Orthopedic Foot & Ankle Society ankle hindfoot score was used to obtain clinical data. Results were compared to those from 20 healthy participants. Furthermore, correlations between the American Orthopedic Foot & Ankle Society hindfoot score and the results of the gait analysis were evaluated. Results Statistical parametric mapping showed significant differences for the Foot Tibia Dorsal Flexion for patients after 9 weeks (53–75%: p  = 0.001) and patients after 26 weeks (58–70%: p  = 0.011) compared to healthy participants, respectively. Furthermore, significant differences regarding the tibio-talar dorsal flexion for patients 9 weeks after surgery (15–40%: p  < 0.001; 56,5–70%: p  = 0.007; 82–88%: p  = 0.033; 97–98,5%: p  = 0.048) as well as patients after 26 weeks (62,5–65%: p  = 0.049) compared to healthy participants, respectively. There were no significant differences looking at the medial arch and the subtalar inversion. Moreover, significant differences regarding the ground reaction force were found for patients after 9 weeks (0–17%: p  < 0.001; 21–37%: p  < 0.001; 41–54%: p  < 0.001; 60–64%: p  = 0.013) as well as patients after 26 weeks (0–1,5%: p  = 0.046; 5–15%: p  < 0.001; 27–33%: p  = 0.001; 45–49%: p  = 0.005; 57–59%: p  = 0.049) compared to healthy participants, respectively. In total, the range of motion in the tibio-talar joint and the medial arch was reduced in affected patients compared to healthy participants. Patients showed significant increase of the range of motion between 9 and 26 weeks. Conclusions This study shows, that patients affected by ankle fractures show limited mobility in the tibio-talar joint and the medial arch when compared to healthy participants. Even though the limitation of motion remains at least over a period of 26 weeks, a significant increase can be recognized over time. Furthermore, if we look at the absolute values, the patients’ values tend to get closer to those of the control group. Trial registration This study is registered at the German Clinical Trials Register ( DRKS00023379 ).

BackgroundVarious dietary supplements have been reported to enhance muscular perfusion in athletes practicing resistance training, especially through modulation of nitric oxide signaling.ObjectivesThe aim of this study was therefore to investigate selected ‘NO-boosting’ supplements in a real-life setting i) to generate novel hypotheses and perfusion estimates for power calculation in view of a definitive trial and ii) to assess the feasibility of the study design with particular focus on the use of contrast-enhanced ultrasound (CEUS) for perfusion quantification.MethodsThirty young male athletes (24 ± 4 years) regularly practicing resistance training were enrolled in this three-arm, placebo(PL)-controlled crossover trial with ingestion of two commercially available supplements: an amino acid combination (AA) (containing 3 g of L-arginine-hydrochloride and 8 g of L-citrulline-malate) and 300 mg of a specific green tea extract (GTE). After intake, CEUS examinations of the dominant biceps brachii muscle were performed under resting conditions and following standardized resistance exercising. Quantitative parameters of biceps perfusion (peak enhancement, PE; wash-in perfusion index, WiPI) and caliber were derived from corresponding CEUS video files. Additionally, subjective muscle pump was determined after exercise.ResultsFor PE, WiPI, and biceps caliber, the standard deviation (SD) of the within-subject differences between PL, AA, and GTE was determined, thereby allowing future sample size calculations. No significant differences between PL, AA, and GTE were observed for biceps perfusion, caliber, or muscle pump. When comparing resting with post-exercise measurements, the increase in biceps perfusion significantly correlated with the caliber increase (PE: r = 0.266, p = 0.0113; WiPI: r = 0.269, p = 0.0105). Similarly, the biceps perfusion correlated with muscle pump in the post-exercise conditions (PE: r = 0.354, p = 0.0006; WiPI: r = 0.350, p = 0.0007). A high participant adherence was achieved, and the acquisition of good quality CEUS video files was feasible. No adverse events occurred.ConclusionBased on our novel examination protocol, CEUS seems to be feasible following higher-load resistance exercising and may be used as a new method for high-resolution perfusion quantification to investigate the effects of pre-exercise dietary supplementation on muscle perfusion and related muscle size dynamics.

Background Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®). Methods This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis. Discussion The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation. Trial registration German Clinical Trials Register (DRKS) DRKS00013562 . Registered on July, 12, 2017.

Background: In this prospective safety study, we investigated if the characteristic cytokine expression during bone regeneration is manipulated by the local application of bone morphogenetic protein-7 (BMP-7) in non-union surgery. Therefore, the levels of insulin like growth factor 1 (IGF-1), platelet-derived growth factor AB (PDGF-AB) and transforming growth factor beta (TGF-β) were compared between patients with the gold standard use of autologous bone graft (ABG) and those with additional application of BMP-7 as part of the diamond concept. Patients and methods: Between 2009 and 2014, of the 153 patients with tibial and femoral non-unions, a matched pair analysis was performed to compare the serological cytokine expressions. Blood samples were collected preoperatively, 1, 2 and 6 weeks as well as 3 and 6 months after non-union surgery. Matching criteria were smoking status, fracture location, gender, age and body mass index (BMI). Patients in G1 (n=10) were treated with ABG and local BMP-7 while their matching partners in G2 (n=10) received ABG only. The routine clinical and radiologic follow-up was 1 year. Results: Although the IGF-1 quantification in G2 showed higher pre- and postoperative values compared to G1 (p<0.05), the courses of both groups were similar. Likewise, PDGF-AB and TGF-β expressions appeared similar in G1 and G2 with peaks in both groups at 2 weeks follow-up. Osseous consolidation was assessed in all operated non-unions. The adjunct application of BMP-7 did not cause any pathologic cytokine expression. Conclusion: Similar expressions of the serum cytokines IGF-1, PDGF-AB and TGF-β were demonstrated in non-union patients treated with ABG and additional application of BMP-7 according to the diamond concept. Our findings indicate that the local application of BMP-7, which imitates the physiologic secretion of growth factors during bone regeneration, is safe and without the risk of abnormal systemic cytokine expression. Studies with higher patient numbers will have to validate these assumptions.

Introduction Acute syndesmosis tears can be treated by static screw or dynamic fixation. Various studies have compared these techniques regarding postoperative outcome. However, to our knowledge, no study has used 3D-instrumented gait analysis (IGA). We hypothesized that a dynamic fixation would perform non-inferior to screw fixation in terms of biomechanical and clinical outcomes. Materials and methods Patients were prospectively randomized to both groups. All patients received the same follow-up rehabilitation and consultations (6 and 12 weeks; 6 and 12 months) postoperatively. Standardized questionnaires were used to objectify pain and ankle function. At 6 months follow-up, IGA was conducted additionally to objectify the biomechanical outcome. Results Twenty-five patients in the dynamic fixation (DF) group using TightRope® and twenty-five in the screw fixation group (SF) completed gait analysis. The DF group showed significantly higher mean values for maximum moment in the affected ankle joint (DF: 1.40 ± 0.21 Nm, SF: 1.23 ± 0.30 Nm; p = 0.023) and the unaffected ankle joint (DF: 1.52 ± 0.20 Nm, SF: 1.37 ± 0.27 Nm; p = 0.035). The difference between the affected and unaffected ankle joint was significantly higher in the SF group for active plantarflexion (DF: 1.52 ± 0.20°, SF: 1.37 ± 0.27°; p = 0.035). Both dynamic and screw fixation groups exhibited significantly reduced plantarflexion during the push-off and early swing phase, with moments and powers in the ankle joint also significantly impaired. Conclusions Our study demonstrated that dynamic fixation has better or similar biomechanical and clinical outcomes compared to screw fixation. Future research should focus on biomechanical differences during gait as well as clinical outcomes in case of earlier weight-bearing after dynamic fixation. Trial registration number (TRN) DRKS00013562 Date of Registration: 07/12/2017.

Purpose Medial knee osteoarthritis can be treated with medial open wedge high tibial osteotomy (OWHTO). We sought to investigate osseous consolidation of the osteotomy with and without autologous bone grafts (ABG) to detect possible benefits of ABG in osseous healing and functional outcome. Methods In this prospective study, patients without graft transplantation were compared to those receiving ABG after medial OWHTO. They were followed up 6 weeks, 12 weeks, 6 months and 12 months postoperatively. Radiographic progress of consolidation, clinical scores, contrast-enhanced ultrasound (CEUS) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) were assessed at each appointment. Results A total of 35 patients were enrolled, 20 without and 15 with graft transplantation. Radiologic evaluation showed a significantly earlier consolidation of the osteotomy gaps ( p  = 0.012) in patients with ABG, resulting in a significantly higher rate of consolidation 12 months after surgery (60% without bone graft vs. 100% with bone graft, p  = 0.006). At 6 weeks as well as 6-month follow-up, a tendency of earlier consolidation with ABG was apparent, but not statistically significant (6 weeks: 50% vs. 80%, p  = 0.089; 6 months: 30% vs. 60%, p  = 0.097). CEUS and DCE-MRI showed physiological perfusion of the osteotomy gaps in both groups. A tendency to better function and less pain in patients with ABG was recognizable. Conclusion In our study, autologous bone grafting evocated earlier osseous consolidation after medial OWHTO and showed a tendency to a better functional outcome.

Little is known about the impact of the impaired limb on the uninvolved side, which might influence the overall functional outcome in individuals with unilateral cerebral palsy (CP). The objective of this work was to perform an assessment considering the kinematics/joint moments and ground reaction forces (GRFs). Eighty-nine individuals with unilateral CP were included and classified according to their functional impairment. Level-specific differences according to the Gross Motor Function Classification System (GMFCS), including pelvic and trunk movements, were analyzed using instrumented 3D gait analysis (IGA). Anterior trunk and pelvic tilt, trunk lean/pelvic obliquity, pelvic internal rotation, hip adduction, and external hip rotation, as well as pronounced flexion (ankle dorsiflexion), at all joint levels were significant kinematic alterations. Concerning joint moments, the most remarkable alterations were hip and ankle flexion, hip abduction, knee varus/valgus, and transversal joint moments at all levels (external rotation moments in particular). The most remarkable differences between GMFCS levels were at proximal segments. The kinematics and joint moments of the sound limb in patients with unilateral CP differ significantly from those of healthy individuals—partially concomitant to those of the involved side or as motor strategies to compensate for transversal malalignment and leg-length discrepancies (LLDs). GRF showed almost identical patterns between GMFCS levels I and II, indicating an unloading of the involved limb. Compensatory motor strategies of the sound limb do not influence functional outcomes.

In this prospective safety study, we investigated if the characteristic cytokine expression during bone regeneration is manipulated by the local application of bone morphogenetic protein-7 (BMP-7) in non-union surgery. Therefore, the levels of insulin like growth factor 1 (IGF-1), platelet-derived growth factor AB (PDGF-AB) and transforming growth factor beta (TGF-β) were compared between patients with the gold standard use of autologous bone graft (ABG) and those with additional application of BMP-7 as part of the diamond concept. Between 2009 and 2014, of the 153 patients with tibial and femoral non-unions, a matched pair analysis was performed to compare the serological cytokine expressions. Blood samples were collected preoperatively, 1, 2 and 6 weeks as well as 3 and 6 months after non-union surgery. Matching criteria were smoking status, fracture location, gender, age and body mass index (BMI). Patients in G1 (n=10) were treated with ABG and local BMP-7 while their matching partners in G2 (n=10) received ABG only. The routine clinical and radiologic follow-up was 1 year. Although the IGF-1 quantification in G2 showed higher pre- and postoperative values compared to G1 ( <0.05), the courses of both groups were similar. Likewise, PDGF-AB and TGF-β expressions appeared similar in G1 and G2 with peaks in both groups at 2 weeks follow-up. Osseous consolidation was assessed in all operated non-unions. The adjunct application of BMP-7 did not cause any pathologic cytokine expression. Similar expressions of the serum cytokines IGF-1, PDGF-AB and TGF-β were demonstrated in non-union patients treated with ABG and additional application of BMP-7 according to the diamond concept. Our findings indicate that the local application of BMP-7, which imitates the physiologic secretion of growth factors during bone regeneration, is safe and without the risk of abnormal systemic cytokine expression. Studies with higher patient numbers will have to validate these assumptions.

Background: In this prospective safety study, we investigated if the characteristic cytokine expression during bone regeneration is manipulated by the local application of bone morphogenetic protein-7 (BMP-7) in non-union surgery. Therefore, the levels of insulin like growth factor 1 (IGF-1), platelet-derived growth factor AB (PDGF-AB) and transforming growth factor beta (TGF-[beta]) were compared between patients with the gold standard use of autologous bone graft (ABG) and those with additional application of BMP-7 as part of the diamond concept. Patients and methods: Between 2009 and 2014, of the 153 patients with tibial and femoral non-unions, a matched pair analysis was performed to compare the serological cytokine expressions. Blood samples were collected preoperatively, 1, 2 and 6 weeks as well as 3 and 6 months after non-union surgery. Matching criteria were smoking status, fracture location, gender, age and body mass index (BMI). Patients in G1 (n=10) were treated with ABG and local BMP-7 while their matching partners in G2 (n=10) received ABG only. The routine clinical and radio-logic follow-up was 1 year. Results: Although the IGF-1 quantification in G2 showed higher pre- and postoperative values compared to G1 (p<0.05), the courses of both groups were similar. Likewise, PDGF-AB and TGF-[beta] expressions appeared similar in G1 and G2 with peaks in both groups at 2 weeks follow-up. Osseous consolidation was assessed in all operated non-unions. The adjunct application of BMP-7 did not cause any pathologic cytokine expression. Conclusion: Similar expressions of the serum cytokines IGF-1, PDGF-AB and TGF-[beta] were demonstrated in non-union patients treated with ABG and additional application of BMP-7 according to the diamond concept. Our findings indicate that the local application of BMP-7, which imitates the physiologic secretion of growth factors during bone regeneration, is safe and without the risk of abnormal systemic cytokine expression. Studies with higher patient numbers will have to validate these assumptions. Keywords: bone morphogenetic protein, cytokine, non-union, safety