The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study.

BACKGROUND: The Vega System® PS (Aesculap AG, Tuttlingen, Germany) is an advanced, third generation fixed implant that aims to mimic natural knee kinematics by optimizing pivotal motion while reducing surface stress. This study evaluated mid-term survival and clinical outcomes, including range of motion (ROM) of the modern posterior stabilized implant in order to analyse whether this biomechanically successful implant reaches good results in situ. METHODS: The first 100 patients to receive the Vega PS System for total knee arthroplasty were invited to take part in this single centre, single surgeon study. Of these, 84 patients were clinically assessed 5-6 years postoperatively. Data which was obtained during this follow-up examination included revision data, range of motion and clinical scores. RESULTS: The 5-year survival rate for exchange of any component was 97.6%, whereby two patients required replacement of the polyethylene gliding surface. Secondary patella resurfacing was performed in 7 patients. Significantly improved results in comparison to the preoperative state could be obtained at the follow-up: KOOS improved from 39.4 to 78.8, SF-12 PCS improved from 32.1 to 42 SF-12 MCS improved from 46 to 53.8 and patella pain improved from 2.7 to 0.3. The mean ROM of the 84 patients after 5 years was 133.1° and mean total KSS was 189.9. DISCUSSION & CONCLUSIONS: This study demonstrates a high survival rate of the Vega PS System® and significant improvements in clinical outcomes 5 years after implantation. The obtained mean ROM indicates that this implant provides good flexibility of the knee joint, allowing a high number of activities. However, due to the rate of secondary patella implantation, routine resurfacing of the patella for all PS TKA cases is highly recommended. CLINICAL TRIALS REGISTRATION: The study was registered at clinicaltrials.gov (NCT02802085).

Prevalence of degenerative vertebral disc changes in elite female Crossfit athletes - a cross-sectional study.

BACKGROUND: Crossfit athletes consistently recruit or transfer high levels of repetitive forces through the spine, and MRI has documented a higher rate of intervertebral disc degeneration in athletes compared with matched controls. The aim of this study was to evaluate early degenerative spinal disc changes in elite female CrossFit athletes quantified by 3.0 Tesla magnetic resonance imaging (MRI) matched with female none-athletes. METHODS: In a cross-sectional single-center study 19 asymptomatic adult participants, nine German female elite Crossfit athletes and ten female participants underwent spinal MRI (3.0T). Demographic data, spinal clinical examination results and sport-specific performance parameters were collected prior to the MRI. The primary outcome was the prevalence of degenerative spinal disc changes. The secondary outcome was the grade of degeneration using Pfirrmann grading. RESULTS: A total of 437 discs underwent spinal MRI (3.0T). The prevalence of early degenerative disc disease was not increased. Pfirrmann degenerative grade did not show significant differences among groups. CONCLUSION: Asymptomatic female elite Crossfit athletes do not show an increased prevalence of degenerative disc disease. Compared to a sex-matched control group, high training volume in Crossfit does not correlate to a higher incidence of degenerative disc changes in young females.

The anterior transmuscular intrapelvic approach for the treatment of acetabular fractures-a new anterior surgical strategy.

The anterior ilioinguinal and the posterior Kocher-Langenbeck approach have long been the standard surgical approaches to the acetabulum. The last decade has witnessed the development of so-called intrapelvic approaches for anterior pathologies because they provide better exposure of the quadrilateral plate. Currently, the modified Stoppa approach and the pararectus approach are frequently used by surgeons for the treatment of acetabular fractures. We investigated an even more direct access to the entire anterior column and the quadrilateral plate via the abdominal wall muscles, between the incisions for the ilioinguinal and the pararectus approach.After intensive study of anatomic specimens, a cadaver dissection was performed prior to clinical application. The approach was then used in 20 patients who were assessed retrospectively.Postoperative CT scans showed that, according to the Matta scoring system, the quality of fracture reduction was "anatomical" (≤ 1 mm) in 12 (60%), "imperfect" (2-3 mm) in four (20%), and "poor" (> 3 mm) in four (20%) patients. Numerous minor complications were observed; the majority of these had resolved at the time of discharge.In conclusion, the anterior transmuscular intrapelvic approach (ATI) is a safe and effective alternative to the ilioinguinal and pararectal approaches, and may be regarded as an evolutionary advancement of traditional procedures.

Long-term Efficacy of Percutaneous Epidural Neurolysis of Adhesions in Chronic Lumbar Radicular Pain: 10 Year Follow-up of a Randomized Controlled Trial.

BACKGROUND: No long-term follow-up data exist in any treatment for chronic radicular pain occurring with disc pathology and after failed back surgery. A previous randomized controlled trial (RCT) has proven efficacy in short-term follow-up as an evidence-based effective therapeutic option. OBJECTIVES: Long term data is needed to determine the efficacy and cost- effectiveness of minimal invasive procedures. The present study reports 10 year follow-up results from the randomized trial. STUDY DESIGN: A prospective, randomized, placebo-controlled, interventional clinical trial. A power calculation was based on a previous feasibility trial. SETTING: University medical centers. METHODS: After a 4 year enrollment phase, 381 patients with chronic radicular pain persisting beyond 4 months, who failed conservative treatments, were screened. Ninety patients were enrolled. Patients were randomly assigned to receive percutaneous epidural lysis of adhesions or placebo with concealed allocation in permuted blocks of 4 to 8 patients each, and stratified by treatment center. The primary outcomes were a mean change of the Oswestry Disability Index (ODI) scores and Visual Analog Scale (VAS), one and 10 years after intervention. For each rating scale an analysis of variance with the within-patient factor time (baseline, one year follow-up, 10 year follow-up) and the between-patient factor treatment (lysis, placebo) was used. RESULTS: Homogeneity was shown at baseline between the groups. The ODI and VAS scores were significantly better one and 10 years in the lysis group vs the control group. The ODI in the lysis group improved from 55.3 ± 11.6 to 9.6 ± 9.3 after one year and to 11.7 ± 14.2 after 10 years. The placebo group also improved from 55.4 ± 11.5 to 30.7 ± 14.2 after one year and to 24.8 ± 12.0 after 10 years. The VAS improved from 6.7 ± 1.1 to 1.2 ± 1.1 after one year and to 1.5 ± 1.4 after 10 years in the lysis group and from 6.7 ± 1.1 to 2.8 ± 1.5 after one year and to 2.9 ± 1.3 after 10 years after placebo intervention. The statistical difference of the ODI and VAS between the treatment and control groups remain significant up to 10 years. No treatment-related severe adverse effects occurred within the 10 years, but minor transient neurological effects were seen directly after the intervention. LIMITATIONS: The long-term effects of single treatment components cannot be specified as no imaging examination was performed at 10 year follow-up. A large variety of unanalyzed noninvasive treatments were done within the 10 years. Some patients did not clearly remember the intervention after 10 years. Uncontrolled effects such as higher inhomogeneity of biometric properties, concomitant therapies, pain tolerance level, or just social effects could occur, but were not analyzed in the trial. CONCLUSION: This is the first 10 year follow-up report of a placebo-controlled RCT showing efficacy of the minimally invasive percutaneous adhesiolysis procedure for patients with chronic lumbosacral radicular pain. No alternative evidence-based treatment modality with 10 year follow-up is available to be recommended. This procedure should be considered as the first treatment option for patients with chronic lumbosacral radicular pain.

[Hybrid operating room : Application in trauma surgery and orthopaedics]. / Der Hybridoperationssaal : Anwendung in Unfallchirurgie und Orthopädie.

BACKGROUND: For some years now, more and more hospitals in Germany have acquired so-called hybrid operating rooms. In these operating rooms it is possible to produce three-dimensional imaging during the operation. Originally developed for cardiovascular surgery, these rooms are increasingly being used for interdisciplinary purposes. Previous experiences in the use for trauma surgery and orthopedics has shown that three-dimensional imaging can have a positive effect on the success of surgery. OBJECTIVE: Can minimally invasive operations on the spine benefit intraoperatively from three-dimensional imaging with respect to operating times and results? METHODS: Minimally invasive operations on the spine performed at the UKSH Campus Kiel between 2015 and 2018 in the hybrid operating room were considered. These were compared to minimally invasive spinal surgery performed in conventional operating rooms. RESULTS: As is usual with the establishment of a new procedure, there are initially longer operating times. With regular use and appropriate training and experience of the personnel, the processes can be optimized. CONCLUSION: Due to the accuracy of the three-dimensional imaging, errors can be detected and eliminated at an early stage during the operation. Revisions are less frequent. In contrast, there is increased radiation exposure and sometimes longer operation and anesthesia times.

A new multiple trauma model of the mouse.

BACKGROUND: Blunt trauma is the most frequent mechanism of injury in multiple trauma, commonly resulting from road traffic collisions or falls. Two of the most frequent injuries in patients with multiple trauma are chest trauma and extremity fracture. Several trauma mouse models combine chest trauma and head injury, but no trauma mouse model to date includes the combination of long bone fractures and chest trauma. Outcome is essentially determined by the combination of these injuries. In this study, we attempted to establish a reproducible novel multiple trauma model in mice that combines blunt trauma, major injuries and simple practicability. METHODS: Ninety-six male C57BL/6 N mice (n = 8/group) were subjected to trauma for isolated femur fracture and a combination of femur fracture and chest injury. Serum samples of mice were obtained by heart puncture at defined time points of 0 h (hour), 6 h, 12 h, 24 h, 3 d (days), and 7 d. RESULTS: A tendency toward reduced weight and temperature was observed at 24 h after chest trauma and femur fracture. Blood analyses revealed a decrease in hemoglobin during the first 24 h after trauma. Some animals were killed by heart puncture immediately after chest contusion; these animals showed the most severe lung contusion and hemorrhage. The extent of structural lung injury varied in different mice but was evident in all animals. Representative H&E-stained (Haematoxylin and Eosin-stained) paraffin lung sections of mice with multiple trauma revealed hemorrhage and an inflammatory immune response. Plasma samples of mice with chest trauma and femur fracture showed an up-regulation of IL-1ß (Interleukin-1ß), IL-6, IL-10, IL-12p70 and TNF-α (Tumor necrosis factor- α) compared with the control group. Mice with femur fracture and chest trauma showed a significant up-regulation of IL-6 compared to group with isolated femur fracture. CONCLUSIONS: The multiple trauma mouse model comprising chest trauma and femur fracture enables many analogies to clinical cases of multiple trauma in humans and demonstrates associated characteristic clinical and pathophysiological changes. This model is easy to perform, is economical and can be used for further research examining specific immunological questions.

Electromagnetic Transduction Therapy for Achilles Tendinopathy: A Preliminary Report on a New Technology.

A parallel prospective feasibility study was performed on 53 patients with chronic mid-portion Achilles tendinopathy (age 44.7 ± 9.1 years). Of the 53 patients, 28 (active group) were treated using a new electromagnetic (pulsed electromagnetic field) transduction therapy device (Cellactor® MT1) and heel cushions. The device produces an electromagnetic field of 80 milliTesla; a total of 8 treatments was performed within 4 weeks in an outpatient setting, without anesthesia, immobilization, or rest. A control group of 25 patients with a similar duration of symptoms was treated with heel cushions only. At the 12-week assessment point, the visual analog scale scores in both groups had significantly decreased, although the active group had significantly improved visual analog scale scores compared with those of the controls. The Role-Maudsley scores had also significantly improved in both the active and the control groups (p < .00001 and p = .0002, respectively). Electromagnetic transduction therapy could potentially be a useful modality for the treatment of Achilles tendinopathy. It should be compared with the current reference standard of extracorporeal shockwave therapy/radial soundwave therapy with similar level I, II, and III studies.

Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size.

BACKGROUND: It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatment, the pure effect of a placebo treatment alone has never been presented or evaluated. No evidence-based, placebo-therapeutic options are currently available, and no placebo-controlled trials have been performed to elucidate the pure placebo effect. OBJECTIVES: To analyze the pure placebo effect on clinical, chronic pain through a blinded RCT. STUDY DESIGN: A prospective, randomized, placebo-controlled trial. SETTING: Medical University centers. METHODS: One-hundred eighty-two patients suffering from chronic plantar heel pain for over 6 months,who failed to respond to conservative treatments, were screened and 106 of these patients were enrolled into this study. The patients were randomly assigned to receive either a blinded placebo shockwave treatment or an unblinded placebo shockwave treatment. The primary outcome measure was the differences in percentage change of visual analogue scale (VAS) scores 6 weeks after the intervention. The secondary outcome measure was the differences in Roles and Maudsley pain score (RMS) 6 weeks after intervention. As an exploratory outcome, 2-sided group comparisons for baseline characteristics between active treatment and controls were done using the Mann-Whitney-U tests for group comparisons; treatment efficiency was calculated by the effect size coefficient and benchmarks for the Mann-Whitney estimator according to the t-test of 2 independent samples for quantitative data, as well as the Fisher's exact test for binary data. RESULTS: Patients from both groups did not differ with respect to heel pain ratings at baseline, for both the VAS (P = .476) and RMS (P = .810) scores. After 6 weeks, patients receiving the blinded placebo treatment reported less heel pain on both scales (VAS: P = .031; RMS: P = .004). Change scores of pain ratings were significantly higher in the blinded placebo group than in the un-blinded placebo group (VAS: P = .002; RMS: P = .002). LIMITATIONS: As the study represents the first to use an inverse placebo RCT (IPRCT), further conceptual and methodological issues need to be addressed to describe detailed, underlying mechanisms. Specific contextual, intrapersonal, and interpersonal factors modulating the placebo effects should be addressed in future IPRCTs. CONCLUSIONS: The present study indicated that true placebo effect sizes can be analyzed through a proper IPRCT design. Instead of treating high numbers of patients with placebos in a RCT, which increases the risk for subjects not receiving the active treatment, the IPRCT technique seems to be much more appropriate to analyze the effect sizes of any active treatment, in accordance with the Good Clinical Practice guidelines and Declarations of Helsinki. KEY WORDS: Pain, randomized controlled trial, RCT, placebo, effect size, inverse placebo, study, pain therapy.

Reduction and retention of thoracolumbar fractures by minimally invasive stabilisation versus open posterior instrumentation.

PURPOSE: The purpose of this study was in thoracolumbar fractures to assess the effectiveness of minimal invasive stabilisation compared to the open technique with regards to the change in kyphosis angle, the loss of reduction and length of hospital stay. METHODS: The retrospective study consisted of 104 patients who received minimally invasive stabilisation or open stabilisation. Patients were between 15 and 86 years of age, had a thoracolumbar fracture and no neurological deficits. Kyphotic angle (Cobb angle) and loss of reduction was compared after minimal invasive and open stabilisation. The Cobb angle was evaluated directly post operatively, at 6 weeks, 3 months, 6 months and 12 months after surgery. RESULTS: Evaluated patients who received the minimally invasive technique had a shorter surgical intervention time and a shorter hospital stay compared to patients who received the open technique. Kyphosis angle and loss of reduction showed no significant difference compared to open technique. There was also no significant difference between minimally invasive poly-axial and mono-axial stabilisation. CONCLUSION: In this study we provide evidence that MIS instrumentation in selected thoracolumbar fractures can effectively be used without significant differences in loss of reduction compared to open stabilisation. MIS can also sufficiently retain reduction as compared to traditional open techniques. The main advantages are reduced operation time and shorter hospital stay.

Multiple trauma induces serum production of host defence peptides.

Today multiple trauma still is associated with a high mortality. Although severe open fractures and wounds can give rise to local infections and sepsis, the overall infection rate of multiply injured patients is surprisingly low. We have investigated serum of multiply injured patients with respect to antibacterial properties and screened for host defence peptides (HDP) that constitute a class of fast acting and rapidly available molecules preventing bacterial infection. Serum specimens were obtained from multiply injured patients. Radial diffusion assays were performed to investigate antimicrobial properties. Ultrafiltration and heat-inactivation were used to rule out antimicrobial activity of large proteins i.e. complement factors. ELISA was performed to analyse serum concentrations of the human beta-defensins 2 and 3 (hBD-2 and hBD-3), LL-37 and the proinflammatory cytokines interferon-gamma (IFN-γ) and interleukin-6 (IL-6). Serum of multiply injured patients showed greater zones of inhibition in antimicrobial testing against Gram negative und positive bacteria. This effect was mediated by proteins smaller than 10 kDa, inactivation of the complement system does not significantly reduce antibacterial action. hBD-2, hBD-3 and LL-37 concentrations were significantly elevated after trauma and followed different characteristic concentration curves. Similar patterns of concentration profiles were recorded for hBD-2/IL-6 and hBD-3/IFN-γ suggesting a stimulatory influence within their induction process. With this study we provide evidence, that serum of multiply injured patients has by far higher antibacterial capacity than that of healthy donors. As possible mediators we have detected the HDP hBD-2, hBD-3 and LL-37 and their inducers in serum of multiply injured patients.