The effect of the design of the orthosis on the axial load transmission of two flexion abduction orthoses used in treating congenital hip dysplasia.

Background: With an incidence of 2-4% in all newborns, developmental dysplasia of the hip, DDH, represents the most frequent congenital disorder of the skeletal system in Germany. The therapy options are deduced with the help of a sonography. The conservative therapy approach includes the application of flexion abduction orthoses, which lead to a development of the child's hip through abduction and flexion angle. The overall structure of the orthoses puts a strain on the axial skeleton of the children. The following work is intended to clarify what role the design of the orthoses plays in this respect. Methods: Inclusion criterion for the study was fully developed newborns without an indication of skeletal malformations with Type I hip joints according to Graf verified by ultrasound. A total of 19 newborns were recruited and included in the period 3/2013-01/2015. Two types of orthoses used in treating developmental dysplasia of the hip (Tübinger splint, Otto Bock; hip flexion abduction orthosis (Superior orthosis) according to Mittelmeier-Graf, AIDAMED e.K (Kreuz et al., 2012; Mittelmeier et al., 1998; Schmitz et al., 1999), constructions differ, were used. Force was measured with the help of three force sensors, which were even able to be integrated into these without changing the design of the orthosis. In this closed system, force transmission was measured for the duration of a fixed period of two minutes. Findings: The greatest axial force development (overall force) is in the Tübinger splint with an average force of 15.1 N (min. 0.59 N, max. 53.09 N, mean 15.1, SD 2.46). 4.09 N (min. 0.96 N, max. 20.99 N, mean 4.09, SD 0.65) resulted in the Superior orthosis. Significant correlations between body weight and resulting axial traction - on average during the entire measurement period and in movement - can be taken from the statistical analysis regarding the Tübinger splint. Such a correlation cannot be depicted for the Superior orthosis. Interpretation: The analysis of the load transmission of the examined flexion and abduction orthoses reveals differences between the models. The construct of the orthoses in itself appears to play a significant role. Long-term effects of orthosis therapy on a child's axial skeleton have not been studied to date. Furthermore, it seems reasonable to expand the test series to orthoses, the design of which is configured in a similar matter compared to the examined aids. Conclusion: This study proves that the orthotic design has an influence on the infant's axial load.

[Who benefits from medical technical innovations? : A medical and medical economic analysis using the example of lumbar disc surgery]. / Wer profitiert von medizinisch-technischen Innovationen? : Eine medizinische und medizinökonomische Betrachtung am Beispiel lumbaler Bandscheibenoperationen.

Further developments in disease diagnosis and treatment are of immense relevance for advancements in medical care of the population. A detailed cost-benefit analysis of direct and indirect costs is usually unavailable. In the current article, these aspects are investigated using prospectively collected randomized data over two years. Specifically, the surgical treatment of a herniated lumbar disc is addressed, and whether a newly introduced technique (e.g., annular closure device) can lead to a better quality of care and increased patient satisfaction when performed during the standard operation, while also being economically viable.

Sex specific relationships between infants' mental rotation ability and amiotic sex hormones.

Sex differences in mental rotation, robust in adults, have recently been reported for infants' looking times although the pattern of results is not completely conclusive. In this context, organizational effects of gonadal steroids affecting the neural circuitry underlying spatial cognition could be (partly) responsible for the early sex difference. In the present study testosterone and estradiol levels measured in amniotic fluid via ultra performance liquid chromatography and tandem mass spectrometry were used to examine the role of prenatal sex hormones on infants' looking times during mental rotation. N = 208 six-month-old infants participated in an expectation of violation task with 3D cube figures. Mental rotation was defined as the difference in looking times for familiar versus mirrored cube figures whereas vigilance was defined as the sum of both looking times. Sex differences were absent for mental rotation as well as for vigilance. Most importantly, however, for boys mental rotation but not vigilance was correlated with prenatal testosterone but not with estradiol. For girls mental rotation but not vigilance was correlated with prenatal estradiol but not with testosterone although it has to be noted that the testosterone values for girls suffered from a floor effect. Only 5% of the within-sex variance was due to prenatal sex hormones indicating small effects. These findings extend our knowledge concerning organizational effects of prenatal sex hormones on the brain circuitry underlying spatial cognition.

Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation.

BACKGROUND: A larger defect in the annulus fibrosus following lumbar discectomy is a well-known risk factor for reherniation. Procedures intended to prevent reherniation by sealing or occluding the annular defect warrant study in high-risk patients. This study sought to determine 3-year results of lumbar discectomy with a bone-anchored annular closure device (ACD) or lumbar discectomy only (controls) in patients at high risk for reherniation. METHODS: This multicenter randomized trial enrolled patients with sciatica due to lumbar intervertebral disc herniation who failed conservative treatment. Patients with large annular defects after lumbar limited microdiscectomy were intraoperatively randomly assigned to receive ACD or control. Clinical and imaging follow-up was performed at routine intervals over 3 years. Main outcomes included rate of reherniations, reoperations, and endplate changes; leg and back pain scores on a visual analogue scale; Oswestry Disability Index (ODI); Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36; and adverse events adjudicated by a data safety monitoring board. RESULTS: Among 554 randomized patients, the modified intent-to-treat population consisted of 272 patients in which ACD implantation was attempted and 278 receiving control; device implantation was not attempted in 4 patients assigned to ACD. Outcomes at 3 years favored ACD for symptomatic reherniation (14.8% vs. 29.5%; P < 0.001), reoperation (11.0% vs. 19.3%; P = 0.007), leg pain (21 vs. 30; P < 0.01), back pain (23 vs. 30; P = 0.01), ODI (18 vs. 23; P = 0.02), PCS (47 vs. 44; P < 0.01), and MCS (52 vs. 49; P < 0.01). The frequency of all-cause serious adverse events was comparable between groups (42.3% vs. 44.5%; P = 0.61). CONCLUSIONS: The addition of a bone-anchored ACD in patients with large annular defects following lumbar discectomy reduces the risk of reherniation and reoperation, and has a similar safety profile over 3-year follow-up compared with lumbar limited discectomy only. TRIAL REGISTRATION: ClinicalTrials.gov NCT01283438.

[Mandatory Surgical Subinternship in the Final Year of Medical School - a Stepping Stone to Becoming a Surgeon?] / Chirurgisches Pflichttertial im Praktischen Jahr ­ das Sprungbrett in die chirurgische Weiterbildung?

BACKGROUND: The final year is an important time for a medical student as this is when medical knowledge is transformed into medical responsibilities. The field of surgery is firmly anchored in the educational structure as it is mandatory during the practical year of a medical student. The purpose of this paper is to identify factors that influence medical students to choose surgery after the final year of medical school. MATERIALS AND METHODS: An online survey conducted by the AG DGOU 2012 provided complete data sets from a total of 9079 participants. 184 of these had already completed their PJ compulsory sub-internship (tertiary) surgery. These were divided into four groups for analysis: decision to specialise in surgery prior to the PJ compulsory tertiary ("yes, before", JV), during the PJ compulsory ("yes, during", JW), decision against before the PJ compulsory ("no, before", NV) or during the compulsory ("no, during", NW). The total of 38 survey items were summarised for overall assessment, taking into account the decision on subject specialisation. RESULTS: 57.9% of the respondents were positive regarding the overall impression of the surgical internship during their final year. The respondents of the JW group were especially positive, having made the decision to become a surgeon, based on their internship experience during the final year in comparison to the NW group (decision against surgery). We find significant differences in all analysed items: integration into team JW/NW (p ≤ 0.003), acquisition of expertise (p ≤ 0.014), teachers (p ≤ 0.025), quality and structure of teaching (p ≤ 0.043) and overall satisfaction with the required tertial (p ≤ 0.037). CONCLUSION: In comparison to other specialities, in the field of surgery there is the option of recruiting directly within the framework of the compulsory internship. The results reveal unsatisfactory structures from a student perspective. The lack of medical care/support, the insufficient inclusion in therapeutic considerations, the lack of professional knowledge and lack of contact with the teachers are just a few key points that negatively impact the overall outcome of students' satisfaction with the compulsory tertiary education. The results of the present study should serve as motivation and contribute to the restructuring of the compulsory core of the Practical Year, which the Master Plan 2020 will entail.

Postoperative direct health care costs of lumbar discectomy are reduced with the use of a novel annular closure device in high-risk patients.

BACKGROUND CONTEXT: Lumbar discectomy is largely successful surgical procedure; however, reherniation rates in patients with large annular defects are as high as 27%. The expense associated with a revision surgery places significant burden on the healthcare system. PURPOSE: To compare the direct health care costs through 5 years follow-up of conventional discectomy (Control) with those of discectomy supplemented by an adjunctive annular closure device (ACD) in high-risk patients with large annular defects. STUDY DESIGN: This was a cost-effectiveness study. METHODS: All-cause index level reoperations were reviewed from a multicenter, randomized controlled superiority trial that allocated 554 high-risk discectomy patients with large annular defects to either control or ACD. Medicare and private insurer (Humana) direct costs were derived from a commercially available payer database to estimate costs in the US healthcare system, including those associated with facility, surgeon, imaging, follow-up visits, physical therapy, and injections. A 50:50 split between Medicare and commercial insurers was assumed for the base case analysis. The analysis was also performed on a 80:20 commercial:Medicare payer basis. For the base case scenario, a 2-year time horizon and outpatient cost setting was established for the index procedure. Repeat discectomy was assumed to be performed on a 60:40 outpatient-to-inpatient basis. Complications requiring surgery, revisions, and/or fusion were assumed to be managed in the inpatient setting. Total costs of reoperation and per-patient costs of reoperation were compared between groups for both forms of insurers. One author received consulting fees of <$50,000 for the completion of this study, and the other eight authors did not have any financial associations with the current work. Funding for this study was provided by Intrinsic Therapeutics, but all analyses, interpretation, and writing were performed independently by the authors. RESULTS: At two years follow-up, use of the ACD reduced the rate of symptomatic reherniations in a large defect population to 13% compared with 25% in the control group (p<.001). This reduction in symptomatic reherniations in the ACD group translated to a savings of $2,802 per patient in direct health care costs compared with Control at 2 years and $5,315 per patient by 5 years based on 50% private and 50% public (Medicare) payer split. Under the scenario of 80:20 private:public insurance reimbursement, the estimated direct cost savings were $3,215 and $6,099 per patient at 2- and 5-years postoperatively, respectively, with the use of the ACD. CONCLUSIONS: Symptomatic reherniation and reoperation rates were nearly double among control patients compared with ACD-treated patients, which translated to markedly greater per-patient healthcare costs in the control group, where the ACD was not used.

Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial.

BACKGROUND CONTEXT: Patients with large annular defects after lumbar discectomy for disc herniation are at high risk of symptomatic recurrence and reoperation. PURPOSE: The present study aimed to determine whether a bone-anchored annular closure device, in addition to lumbar microdiscectomy, resulted in lower reherniation and reoperation rates plus increased overall success compared with lumbar microdiscectomy alone. DESIGN: This is a multicenter, randomized superiority study. PATIENT SAMPLE: Patients with symptoms of lumbar disc herniation for at least 6 weeks with a large annular defect (6-10 mm width) after lumbar microdiscectomy were included in the study. OUTCOME MEASURES: The co-primary end points determined a priori were recurrent herniation and a composite end point consisting of patient-reported, radiographic, and clinical outcomes. Study success required superiority of annular closure on both end points at 2-year follow-up. METHODS: Patients received lumbar microdiscectomy with additional bone-anchored annular closure device (n=276 participants) or lumbar microdiscectomy only (control; n=278 participants). This research was supported by Intrinsic Therapeutics. Two authors received study-specific support morethan $10,000 per year, 8 authors received study-specific support less than $10,000 per year, and 11 authors received no study-specific support. RESULTS: Among 554 randomized participants, 550 (annular closure device: n=272; control: n=278) were included in the modified intent-to-treat efficacy analysis and 550 (annular closure device: n=267; control: n=283) were included in the as-treated safety analysis. Both co-primary end points of the study were met, with recurrent herniation (50% vs. 70%, P<.001) and composite end point success (27% vs. 18%, P=.02) favoring annular closure device. The frequency of symptomatic reherniation was lower with annular closure device (12% vs. 25%, P<.001). There were 29 reoperations in 24 patients in the annular closure device group and 61 reoperations in 45 control patients. The frequency of reoperations to address recurrent herniation was 5% with annular closure device and 13% in controls (P=.001). End plate changes were more prevalent in the annular closure device group (84% vs. 30%, P<.001). Scores for back pain, leg pain, Oswestry Disability Index, and health-related quality of life at regular visits were comparable between groups over 2-year follow-up. CONCLUSIONS: In patients at high risk of herniation recurrence after lumbar microdiscectomy, annular closure with a bone-anchored implant lowers the risk of symptomatic recurrence and reoperation. Additional study to determine outcomes beyond 2 years with a bone-anchored annular closure device is warranted.

Biomechanical evaluation of different abduction splints for the treatment of congenital hip dysplasia.

BACKGROUND: Abduction splints for the treatment of hip dysplasia normally operate on curbing the legs at the hip flexion and abduction. The forces are absorbed in different designs of shoulder straps and thus diverted to the shoulder and the spine. The present study is the first comparing these undesired forces of two spread orthoses and subsequently the transmitted forces to the infant's spine. METHODS: Between March 2009 and October 2009 the hips of 290 infants were investigated by ultrasound within the first 3 days after birth. Thereof 20 infants with a hip dysplasia Graf type IIc, D or IIIa met our inclusion criteria and were investigated with a Tübinger and a Superior abduction splint. Biomechanical evaluation was performed by using a high-sensitive strain gauge sensor applied to the infant's orthoses between pelvic harness and shoulder straps. FINDINGS: The transmitted forces to the infant's shoulders correlated significantly with their body mass (P<0.05). Maximal forces on the shoulder of the infants and subsequently transmitted forces on the spine were significantly higher (P<0.05) with the Tübinger splint (range 7.6N to 32.3N; arithmetic mean M: 13.7N) in comparison to the Superior orthosis (range 0.0N to 3.5N; M: 0.7N). INTERPRETATION: The Superior orthosis works with primary load transmission to the pelvic bone. Using the Tübinger splint the shoulders of the newborn infants are loaded with a maximum of 93.9% of their body mass. This may influence the development of the growing infant's spine.

Marginal contribution of UKS- versus TKA in varus arthritis of the knee.

BACKGROUND: In recent years, decisions regarding the treatment of individual patients have increasingly been affected by economic considerations. The G-DRG system reimburses sledge endoprosthetic implantations at a much lower rate than surface replacements and at significantly different cost weights (CW). Therefore, when only G-DRG payments are considered, TKA produces higher gains. Taking only these revenues alone into consideration, however, does not provide the basis of an economically sound decision-making process. The target of this research was to present a comparison between variable costs of the two procedures. METHODS: The mean cost and performance data of 28 Endo-Modell (Link company) sledge implantations (UKS) and of 85 NexGen CR surface replacement total knee arthroplasties (TKA; Zimmer company) were compared in 2007. RESULTS: From the perspective of the hospital, UKS treatment is of greater economic advantage when the medical indication is given. In preferring UKS marginal contribution can be improved, and although the relative weighting is comparatively low, the costs are significantly lower than in a comparative analysis of TKA. Based on the length of stay required for each procedure the average daily CW for UKS can be calculated as 0.1728, while being 0.1955 for TKA. The earlier release of the first patient results in another patient being admitted 1.5 days earlier and thus an increase in case mix. Meanwhile, the case-mix index and the costs of care per case decrease ceteris paribus. CONCLUSION: Assuming the correct medical indication, the hospital seeking to maximize its marginal contribution would be wise to select sledge endoprosthesis implantation. Considering the economic perspective of gains and costs, the assumption that TKA is advantageous could not be confirmed in the present study.

Percutaneous fetoscopic laser decompression of congenital high airway obstruction syndrome (CHAOS) from laryngeal atresia via a single trocar--current technical constraints and potential solutions for future interventions.

OBJECTIVE: To alleviate congenital high airway obstruction syndrome (CHAOS) from laryngeal atresia by percutaneous minimally-invasive fetoscopic tracheal decompression using laser. METHODS: The procedure was performed via one trocar under general maternofetal anesthesia in a human fetus with CHAOS from laryngeal atresia at 21+6 weeks of gestation. RESULTS: Normalization of the lung-heart size relationship was observed within days after the procedure. The fetus was delivered by ex utero intrapartum treatment (EXIT) in order to perform a tracheotomy at 31+1 weeks of gestation and survived hospital treatment to discharge. CONCLUSIONS: Percutaneous minimally-invasive fetoscopic decompression of the fetal trachea via a single trocar is feasible in human fetuses with CHAOS from laryngeal atresia.