Non-Union Treatment in the Foot, Ankle, and Lower Leg: A Multicenter Retrospective Study Comparing Conventional Treatment with the Human Allogeneic Cortical Bone Screw (Shark Screw®).

Addressing non-unions involves stabilizing the affected area through osteosynthesis and improving bone biology using bone grafts. However, there is no consensus on the optimal treatment method. This study aims to compare outcomes of non-union surgery using conventional treatment methods (metal hardware ± graft) versus osteosynthesis with the human allogeneic cortical bone screw (Shark Screw®) alone or in combination with a metallic plate. Thirty-four patients underwent conventional treatment, while twenty-eight cases received one or more Shark Screws®. Patient demographics, bone healing, time to bone healing, and complications were assessed. Results revealed a healing rate of 96.4% for the Shark Screw® group, compared to 82.3% for the conventionally treated group. The Shark Screw® group exhibited a tendency for faster bone healing (9.4 ± 3.2 vs. 12.9 ± 8.5 weeks, p = 0.05061). Hardware irritations led to six metal removals in the conventional group versus two in the Shark Screw® group. The Shark Screw® emerges as a promising option for personalized non-union treatment in the foot, ankle, and select lower leg cases, facilitating effective osteosynthesis and grafting within a single construct and promoting high union rates, low complications, and a rapid healing process.

Simplified Pain Management Including Fentanyl TTS in PACU Patients With Hip Fracture Surgery to Improve Patients' Well-Being: A Double-Blind Randomized Trial.

PURPOSE: Adequate pain management is eminently relevant for elderly and more vulnerable patients with hip fractures in the setting of pre and postoperative pain. This study compares postoperative hip fracture patients treated with standard pain management with a variety of medications or an approach with only one option in each medication category (nonopioid: acetaminophen; opioid: fentanyl TTS 12,5 mcg/hour; rescue medication: piritramide) to simplify the treatment algorithm for nurses and improve patient well-being. DESIGN: Double-blind randomized controlled trial. METHODS: The sample was cognitively intact patients (N = 141) with hip fractures in a tertiary university hospital. Administration of fentanyl 12 mcg/hour transdermal therapeutic system was administered by the nurses in the postanesthesia care unit (PACU) to address basal wound pain to improve patient well-being and patient treatment in the PACU for 24 hours to better control for early complications. FINDINGS: Well-being was equally increased in both groups in comparison to our preintervention data from 35.7% to over 60% and did not differ significantly between the intervention and control group. No statistically significant differences in numeric rating scale scores, rescue opioid dosage (piritramide i.v.) or in complications were present. CONCLUSIONS: This one-size-fits-all simplified pain management approach did not improve patient well-being or any other outcome but highlighted the importance of adequate pain management and a sufficient nurse-to-patient ratio.

Mg-Zn-Ca Alloy (ZX00) Screws Are Resorbed at a Mean of 2.5 Years After Medial Malleolar Fracture Fixation: Follow-up of a First-in-humans Application and Insights From a Sheep Model.

BACKGROUND: In the ongoing development of bioresorbable implants, there has been a particular focus on magnesium (Mg)-based alloys. Several Mg alloys have shown promising properties, including a lean, bioresorbable magnesium-zinc-calcium (Mg-Zn-Ca) alloy designated as ZX00. To our knowledge, this is the first clinically tested Mg-based alloy free from rare-earth elements or other elements. Its use in medial malleolar fractures has allowed for bone healing without requiring surgical removal. It is thus of interest to assess the resorption behavior of this novel bioresorbable implant. QUESTIONS/PURPOSES: (1) What is the behavior of implanted Mg-alloy (ZX00) screws in terms of resorption (implant volume, implant surface, and gas volume) and bone response (histologic evaluation) in a sheep model after 13 months and 25 months? (2) What are the radiographic changes and clinical outcomes, including patient-reported outcome measures, at a mean of 2.5 years after Mg-alloy (ZX00) screw fixation in patients with medial malleolar fractures? METHODS: A sheep model was used to assess 18 Mg-alloy (ZX00) different-length screws (29 mm, 24 mm, and 16 mm) implanted in the tibiae and compared with six titanium-alloy screws. Micro-CT was performed at 13 and 25 months to quantify the implant volume, implant surface, and gas volume at the implant sites, as well as histology at both timepoints. Between July 2018 and October 2019, we treated 20 patients with ZX00 screws for medial malleolar fractures in a first-in-humans study. We considered isolated, bimalleolar, or trimalleolar fractures potentially eligible. Thus, 20 patients were eligible for follow-up. However, 5% (one patient) of patients were excluded from the analysis because of an unplanned surgery for a pre-existing osteochondral lesion of the talus performed 17 months after ZX00 implantation. Additionally, another 5% (one patient) of patients were lost before reaching the minimum study follow-up period. Our required minimum follow-up period was 18 months to ensure sufficient time to observe the outcomes of interest. At this timepoint, 10% (two patients) of patients were either missing or lost to follow-up. The follow-up time was a mean of 2.5 ± 0.6 years and a median of 2.4 years (range 18 to 43 months). RESULTS: In this sheep model, after 13 months, the 29-mm screws (initial volume: 198 ± 1 mm3) degraded by 41% (116 ± 6 mm3, mean difference 82 [95% CI 71 to 92]; p < 0.001), and after 25 months by 65% (69 ± 7 mm3, mean difference 130 [95% CI 117 to 142]; p < 0.001). After 13 months, the 24-mm screws (initial volume: 174 ± 0.2 mm3) degraded by 51% (86 ± 21 mm3, mean difference 88 [95% CI 52 to 123]; p = 0.004), and after 25 months by 72% (49 ± 25 mm3, mean difference 125 [95% CI 83 to 167]; p = 0.003). After 13 months, the 16-mm screws (initial volume: 112 ± 5 mm3) degraded by 57% (49 ± 8 mm3, mean difference 63 [95% CI 50 to 76]; p < 0.001), and after 25 months by 61% (45 ± 10 mm3, mean difference 67 [95% CI 52 to 82]; p < 0.001). Histologic evaluation qualitatively showed ongoing resorption with new bone formation closely connected to the resorbing screw without an inflammatory reaction. In patients treated with Mg-alloy screws after a mean of 2.5 years, the implants were radiographically not visible in 17 of 18 patients and the bone had homogenous texture in 15 of 18 patients. No clinical or patient-reported complications were observed. CONCLUSION: In this sheep model, Mg-alloy (ZX00) screws showed a resorption to one-third of the original volume after 25 months, without eliciting adverse immunologic reactions, supporting biocompatibility during this period. Mg-alloy (ZX00) implants were not detectable on radiographs after a mean of 2.5 years, suggesting full resorption, but further studies are needed to assess environmental changes regarding bone quality at the implantation site after implant resorption. CLINICAL RELEVANCE: The study demonstrated successful healing of medial malleolar fractures using bioresorbable Mg-alloy screws without clinical complications or revision surgery, resulting in pain-free ankle function after 2.5 years. Future prospective studies with larger samples and extended follow-up periods are necessary to comprehensively assess the long-term effectiveness and safety of ZX00 screws, including an exploration of limitations when there is altered bone integrity, such as in those with osteoporosis. Additional use of advanced imaging techniques, such as high-resolution CT, can enhance evaluation accuracy.

Reoperation Rate of Internal Fixation for Femoral Neck Fractures in the Elderly - A Retrospective Follow-Up Study in 116 Patients With an Exploration of Risk Factors.

Aim: Internal fixation of femoral neck fractures is a widely used procedure that is comparatively less invasive and faster than hip replacement. While head preserving internal fixation of these fractures are still preferred where feasible, a faster recovery and lower reoperation rates make arthroplasty increasingly more appealing, in spite of being a more invasive option. Our aim was to determine the reoperation rate after internal fixation at our institution and to explore relevant risk factors in a geriatric population. Methods: This monocentric follow-up study was conducted analyzing 116 patients aged 65 and older with femoral neck fractures who were surgically treated with either cancellous screws or dynamic hip screws between 2010 and 2017. We retrospectively collected longitudinal data from our patient database, supplemented by a telephone survey, with a follow-up period of at least 18 months. Results: Twenty reoperations, due to either a failure of fixation, avascular necrosis, or posttraumatic osteoarthritis, were identified in our cohort, which constituted a reoperation rate of 17.2% (20/116). Fracture displacement was significantly associated with the reoperation risk (HR 8, CI 3-20; P < .001). The reoperation rate was 52.2% in displaced fractures vs 8.9% in undisplaced fractures. No link was found between the reoperation rate and gender, age, BMI, ASA score, type of implant, quality of internal fixation, type of living accommodation, and pre-fracture mobility. Conclusion: Internal fixation has been found to be an effective option in elderly patients with undisplaced fractures regardless of their specific age, cognitive ability or physical condition. In displaced fractures the reoperation rate was found to be high, therefore a primary hip replacement should be recommended.

[Sterile puncture of large joints]. / Sterile Punktion großer Gelenke.

OBJECTIVE: Puncture of large joints is performed for diagnostic purposes on the one hand and for the treatment of joint pathologies on the other. Puncture can be used for rapid pain relief by relieving effusions or intra-articular hematomas. The obtained puncture specimen allows immediate visual assessment and subsequent microscopic-cytological and microbiological evaluation in the laboratory. INDICATIONS: The indication for puncture of a large joint is for diagnosis and/or therapy of inflammatory, traumatic or postoperative joint problems. Diagnostic punctures are used to obtain punctate, to differentiate the location of pain or (rarely) to apply contrast medium for magnetic resonance arthrography. Therapeutic punctures allow the injection of drugs or platelet-rich plasma (PRP) as well as the relief or drainage of effusions. CONTRAINDICATIONS: If there are inflammatory skin alterations-especially purulent inflammation-joint punctures through these lesions are absolutely contraindicated. Special attention is necessary if the patients are on anticoagulants. SURGICAL TECHNIQUE: Absolute sterile handling is mandatory. Unnecessary pain can be avoided by a sterile skin wheal of local anesthesia, safe puncture points, and careful handling of the cannulas. POSTOPERATIVE MANAGEMENT: Joint aspiration material has to be handled according to the local, intrahospital rules in a timely manner. Puncture sites are covered with sterile dressings, and if intra-articular medication is administered, the joints have to be passively moved through the range of motion to distribute the medication. Thereafter, compression therapy from distally to proximally while also covering the puncture site avoids recurrence of swelling or hematoma. FACTS: If sterile conditions are guaranteed, infections rarely occur (0.04-0.08%, 4-8/10,000 cases). The risk of false-positive detection of microorganisms is extremely low.

Osteotomy after medial malleolus fracture fixed with magnesium screws ZX00 - A case report.

Magnesium alloys have recently become the focus of research, as these implants exhibit suitable biocompatibility and appropriate mechanical properties (Grün et al., 2018 [1]). Through intensive preclinical and clinical investigation, many questions regarding stability, biocompatibility and degradation behavior have been answered (Holweg et al., 2020 [2]). This case report aims to describe handling of these implants in a revision situation, especially when located in situ. To describe available options and relevant considerations, including planning and implementation, a revision surgery of a healed medial malleolus fracture is presented. A medial malleolus fracture was primarily treated by a trauma surgeon with two magnesium screws. Due to an osteochondral lesion of the talus, a revision surgery with osteotomy of the medial malleolus was necessary after 17 months. In this revision, conventional screw removal was not possible due to the degradation of the implant. Taking the degradation and the yield strength of the implant into account, we have chosen on the one hand to over-drill and on the other to leave and perforate the screw. To the best of our knowledge, this is the first case study focusing on the clinical intraoperative site of human bone stabilized with magnesium screws. Despite the hydrogen gas production that occurs during degradation, a solid bone-to-implant interface was evident. With this report, we want to encourage the surgical user to get more involved with resorbable magnesium implants.

Combined femoral and popliteal nerve block is superior to local periarticular infiltration anaesthesia for postoperative pain control after total knee arthroplasty.

INTRODUCTION: After primary total knee arthroplasty (TKA), local periarticular infiltration anaesthesia (LIA) is a fast and safe method for postoperative pain control. Moreover, ultrasound-guided regional anaesthesia (USRA) with femoral and popliteal block is a standard procedure in perioperative care. Two analgesic regimens for TKA-LIA versus URSA with dexmedetomidine-were compared as an additive to ropivacaine. We hypothesised that the use of URSA provides a superior opioid sparing effect for TKA compared with LIA. METHODS: Fifty patients (planned 188 participants; safety analysis was performed after examining the first 50 participants) were randomised. These patients received LIA into the knee capsule during surgery with 60 ml of ropivacaine 0.5% and 1 ml of dexmedetomidine (100 µg ml-1) or two single-shot URSA blocks (femoral and popliteal block) before surgery with 15 ml of ropivacaine 0.5% and 0.5 ml of dexmedetomidine for each block. Postoperative opioid consumption in the first 48 h, pain assessment and complications were analysed. RESULTS: In the safety analysis, there was a significantly higher need for opioids in the LIA group, with a median oral morphine equivalent of 42.0 [interquartile range (IQR) 23.5-57.0] mg versus 27.0 [IQR 0.0-33.5] mg (P = 0.022). Due to this finding, the study was terminated for ethical considerations according to the protocol. CONCLUSION: This is the first study presenting data on LIA application in combination with dexmedetomidine. A superior opioid-sparing effect of URSA was observed when compared with LIA in TKA when dexmedetomidine is added to local anaesthetics. Also, a longer lasting opioid-sparing effect in the LIA group was observed when compared with the recently published literature; this difference could be attributed to the addition of dexmedetomidine. Therefore, multimodal analgesia regimens could be further improved when LIA or USRA techniques are combined with dexmedetomidine.

Can Hardware Removal be Avoided Using Bioresorbable Mg-Zn-Ca Screws After Medial Malleolar Fracture Fixation? Mid-Term Results of a First-In-Human Study.

Ankle is the most common site of hardware removal, mainly performed within 12 months of the primary surgery. The prominence of the metallic hardware is a frequent cause of pain after fracture fixation. Over the last decade, the development of bioresorbable materials based on magnesium (Mg) has increased. Bioresorbable metals aim to avoid a second surgery for hardware removal. METHODS: Twenty patients with isolated, bimalleolar, or trimalleolar ankle fractures were treated with bioresorbable screws made of Mg, 0.45wt% calcium (Ca) and 0.45wt% zinc (Zn) (ZX00). Patient-reported outcome measures (PROMs) including visual analogue scale (VAS) for pain, the presence of complications 6 and 12 months after surgery and the AOFAS scale after 12 months were reported. The functional outcomes were analysed through the range of motion (ROM) of the ankle joint with a standard goniometer. Degradation products and the bioresorbability of the screws were evaluated using plane radiographs. RESULTS: One patient was lost to follow-up. All patients were free of pain, no complications, shoe conflict or misalignement were reported after 12 months of follow-up. No Mg screws were surgically removed. An additional fixation of the distal fibula or the dorsal tibial fragment with conventional titanium implants (Ti) was performed in 17 patients. Within 12 months after primary refixation, 12 of these patients (71%) underwent a second surgery for Ti hardware removal. The mean AOFAS score was 89.8±7.1 and the difference between the treated and the non-treated site in the ROM of the talocrural joint was 2°±11° after 12 months. Radiolucent areas around the screws were attributed to degradation and did not affect clinical or functional outcomes. After one year, the Mg screw heads could not be detected in the plane radiographs of 17 patients which suggests that the majority of the screw head is degraded without introducing adverse reactions. CONCLUSIONS: At 6 and 12 months, the bioresorbable Mg screws show excellent PROMs without complications or need for screw removal. The resorbability of the screw heads in most of the patients after one year could also provide an advantage over conventional bio-inert implants by avoiding related skin irritation due for instance to shoe conflict.

Comparison of elution characteristics and mechanical properties of acrylic bone cements with and without superficial vancomycin coating (SVC) in the late phase of polymerization.

INTRODUCTION: Antibiotic-loaded bone cements (ALBCs) are used as spacers in two-stage revision arthroplasty for periprosthetic joint infection. We previously described a new technique applying vancomycin powder coating to custom-made cements. To our best knowledge, this method of superficial vancomycin coating (SVC) has not been assessed before. We therefore performed an in-vitro study to determine: (1) whether manually applied SVC strengthened the cements' antibiotic effect; and (2) whether the mechanical requirements for the cements were fulfilled. HYPOTHESIS: SVC increases the antibiotic effect of cement within the first 24hours. METHODS: Cuboid blocks were produced from two commercially available acrylic ALBCs (Palacos R+G and Copal G+V) with and without SVC. Each block was eluted in phosphate-buffered saline at 37°C. Eluates obtained at 1, 2, 3, 4, 5, 10, 15, 30 and 60minutes and 3, 6 and 24hours were evaluated against Staphylococcus aureus (Palacos, Copal) and methicillin-resistant Staphylococcus aureus (MRSA) (Copal) using zone of inhibition tests. Mechanical test results (bending modulus, bending strength) were compared to ISO requirements (≥1800MPa, ≥50MPa). RESULTS: Palacos with SVC produced significantly greater zones of inhibition against Staphylococcus aureus than Palacos without SVC (p=0.002). Copal with SVC showed greater zones of inhibition against both Staphylococcus aureus and MRSA (p=0.002). The antibiotic effect was enhanced by SVC in both cements at every time point within 24hours. The bending modulus and bending strength of Palacos with SVC (2089±166MPa, 60.8±2.6 MPA) and Copal with SVC (2283±195MPa, 56.9±2.4MPa) were significantly above ISO requirements. CONCLUSION: SVC boosts the antibiotic effect of ALBCs in the first 24hours, while maintaining sufficient stability. These findings endorse SVC as a promising additive in septic revision surgery. LEVEL OF EVIDENCE: III; case control study.

Influence of personalised music and ice-tea options on post-operative well-being in the post anaesthesia care unit after general or regional anaesthesia. A pre-post-analysis by means of a questionnaire.

OBJECTIVES: Assessment whether patients' wellbeing and disturbances in the post anaesthesia care unit could be influenced by the consecutive introduction of initially personalised music and then additionally various drink options. DESIGN/SETTING: A pre-post-analysis by means of an anonymised survey with a validated questionnaire in a university hospital in central Europe. MAIN OUTCOME MEASURES: Wellbeing and disturbances in the post anaesthesia care unit. RESULTS: Patients' most frequently reported early postsurgical disturbances (n = 1335) were lack of wellbeing, dry mouth and pain in the surgical area. Reported rates of clinically relevant wellbeing were not statistically different in patients that were offered personalised music (46.5%) or additionally ice-tea (50.6%). No correlation could be found between wellbeing or physical discomfort and headphones or when ice-tea were offered. CONCLUSION: After a decade of increased efforts to improve patients' wellbeing in the postanaesthesia care unit we could not show further influence on it by the introduction of personalised music and ice-tea. We see the need for a more differentiated focus on this topic and the need for exploratory studies on patient perception. The most frequent claims were related to lack of wellbeing, pain in the surgical area and a dry mouth.

Popliteal Artery Entrapment Syndrome (PAES) in a 17-Year-Old Adolescent.

INTRODUCTION: Popliteal artery entrapment syndrome (PAES) is caused by compression of the popliteal artery (PA) due to deranged myotendinous structures. It can be asymptomatic or may present with exercise intolerance, claudication, or even limb-threatening ischemia. The clinical picture depends on the anatomy and degree of vascular compromise. CASE DESCRIPTION: We report a case of a 17-year-old Caucasian male with PAES Type II presenting with intermittent claudication and progression towards acute limb ischemia. DIAGNOSTICS: MRI and MRA helped identifying the aberrant anatomy and thrombotic occlusion. Doppler ultrasound and conventional angiography have also been employed in a stepwise approach. INTERVENTION: The thrombus at the site of occlusion was removed by the use of catheter-directed lysis. Subsequently, popliteal artery release was achieved by myotomy of the aberrant medial head of gastrocnemius muscle (MHGM) and muscle transfer to the medial femoral condyle. A three-month regimen of 60mg edoxaban was recommended after surgery. OUTCOME: Surgical correction of the anomalous anatomy and postoperative anticoagulation led to freedom of symptoms. LESSON: Clinical presentation of PAES mimicking peripheral artery occlusive disease is very rare but potentially limb-threatening. PAES should be considered in young and otherwise healthy individuals.

Pancreatic Fat Is Associated With Metabolic Syndrome and Visceral Fat but Not Beta-Cell Function or Body Mass Index in Pediatric Obesity.

OBJECTIVE: Adolescents with obesity have increased risk of type 2 diabetes and metabolic syndrome (MetS). Pancreatic fat has been related to these conditions; however, little is known about associations in pediatric obesity. The present study was designed to explore these associations further. METHODS: We examined 116 subjects, 90 with obesity. Anthropometry, MetS, blood samples, and oral glucose tolerance tests were assessed using standard techniques. Pancreatic fat fraction (PFF) and other fat depots were quantified using magnetic resonance imaging. RESULTS: The PFF was elevated in subjects with obesity. No association between PFF and body mass index-standard deviation score (BMI-SDS) was found in the obesity subcohort. Pancreatic fat fraction correlated to Insulin Secretion Sensitivity Index-2 and Homeostatic Model Assessment of Insulin Resistance in simple regression; however, when using adjusted regression and correcting for BMI-SDS and other fat compartments, PFF correlated only to visceral adipose tissue and fasting glucose. Highest levels of PFF were found in subjects with obesity and MetS. CONCLUSIONS: In adolescents with obesity, PFF is elevated and associated to MetS, fasting glucose, and visceral adipose tissue but not to beta-cell function, glucose tolerance, or BMI-SDS. This study demonstrates that conclusions regarding PFF and its associations depend on the body mass features of the cohort.