Bankart-Plus zur Behandlung von Patienten mit anteriorer Schulterinstabilität und kleinen bis moderaten Glenoiddefekten

Introduction: A large number of patients with shoulder instability also have small or moderate glenoid defects which are below the threshold size requiring bony glenoid reconstruction but are still large enough to compromise the clinical results after conventional soft-tissue stabilization. Materials and methods: In a prospective cohort study, 30 patients with anterior shoulder instability and small glenoid bone loss (max. 15% surface area) underwent the so-called Bankart plus procedure which includes capsulolabral repair using knotless anchors and interposition of a demineralized cancellous bone matrix (DCBM) between glenoid neck and labrum. Patients underwent preoperative and postoperative (6, 12, and 24 months) clinical assessment including the Western Ontario Shoulder Instability Index (WOSI), Rowe Score (RS), and Subjective Shoulder Value (SSV). Preoperative imaging included a CT scan with 3D reconstruction and measuring of the glenoid defect (Pico method). At 12 months, a follow-up MRI of the operated shoulder was performed to evaluate the integration of the labrum and graft. Results: A total of 30 patients (average age 28 years [range 18-40], n = 4 female, n = 26 male) fulfilling the inclusion and exclusion criteria were enrolled and underwent surgery with the aforementioned technique between September 2018 and October 2020. In 13 cases (43%), an additional Remplissage was conducted. Preoperative clinical assessment showed the following clinical parameter (mean value): WOSI 45 +/- 17%, RS 56 +/- 10 points, and SSV 57 +/- 19%. Preoperative CT scans showed a mean glenoid defect of 7 +/- 3%. So far 25 patients completed radiological and clinical examinations after 12 months and significant improvement has been observed compared to the preoperative values (p < 0.05). The clinical outcome parameters after 1 year are as follows (mean value): WOSI 81 +/- 15%, RS 91 +/- 8 points, and SSV 87 +/- 10%. No recurrent dislocation, no complications or adverse events have been recorded. MRI revealed good integration of the labrum and graft forming a large bump at the anterior glenoid rim. Conclusion: The Bankart plus procedure shows promising clinical and radiological results in the short-term follow-up and is a viable treatment option for patients with anterior shoulder instability and small to moderate glenoid defects

Five freely circulating miRNAs and bone tissue miRNAs are associated with osteoporotic fractures

Für Osteoporose als systemische Skeletterkrankung sind eine Reduktion der Knochenmasse und eine Änderung der Mikrostruktur des Knochengewebes charakteristisch. Laut WHO ist Osteoporose eine der zehn häufigsten Erkrankungen weltweit. In diesem Zusammenhang ist die Untersuchung spezifischer miRNAs ein wichtiger Schritt für neue diagnostische und therapeutische Ansätze. MiRNAs tragen als kurze nicht-kodierende RNA-Abschnitte zur Regulation von Genexpression bei. Unsere Studie befasst sich mit der Identifizierung von spezifischen miRNAs im Serum und Knochen von Patienten mit Osteoporose.Osteoporosis as a systemic skeletal disorder is characterized by increased bone fragility and the risk of fractures. According to the World Health Organization, osteoporosis is one of the ten most common diseases worldwide. In this context, the identification of specific miRNA signatures is an important step for new diagnostic and therapeutic approaches. MiRNAs are short non-coding RNA segments which regulate gene expression. This study aims to identify specific miRNAs in serum and bone of patients with osteoporosis

Differences in Patients’ and Surgeons’ Expectations before Shoulder Stabilization Surgery

Purpose: The primary goal of shoulder stabilization procedures is to re-establish stability and many surgeons measure the success after shoulder stabilization surgery only by the absence of re-dislocation. However, patients might also suffer from pain, loss of range of motion and strength as well as anxiety and stigmatization and therefore have other expectations from a stabilization surgery than just a stable shoulder. Purpose of this study was to analyze if surgeons know what their patients typically expect from a shoulder stabilization surgery. Furthermore, the aim was to analyze the influence of various factors on patients’ expectations. Materials and Methods: 204 patients with a diagnosis of shoulder instability scheduled for surgical treatment were included in this prospective multicentric study. Preoperatively, objective and subjective scores were obtained and patients were asked about their postoperative expectations. Additionally, 25 surgeons were interviewed with regard to what they think their patients expect from the surgery using standardized questions. Results: With regard to postoperative expectations surveyed by the Hospital for Special Surgery questionnaire (HSS), the most important goal to achieve for the patients was ‘stopping the shoulder from dislocation’, followed by ‘to improve the ability to exercise or participate in sports’ and ‘being the shoulder to be back the way it was before the issue started’. The ranking of factors for patients was ‘stability’ as the most important to achieve, followed by ‘movement’, ‘strength’, ‘pain’ and ‘cosmetics’. For surgeons, the order was ‘stability’ (p = 0.004 **), ‘movement’ (p = 0.225), ‘pain’ (p = 0.509), ‘strength’ (p = 0.007 **) and ‘cosmetics’ (p = 0.181). There was a significant difference between patients and surgeons with regard to gaining stability at the cost of movement (p = 0.001 **). Conclusion: Patients and surgeons expectations regarding outcome after surgical shoulder stabilization procedures are quite similar with limited topics of disagreement. Generally, surgeons tend to overrate the importance of stability at the costs of other factors

Five freely circulating miRNAs and bone tissue miRNAs are associated with osteoporotic fractures

Osteoporosis as a systemic skeletal disorder is characterized by increased bone fragility and the risk of fractures. According to the World Health Organization, osteoporosis is one of the 10 most common diseases and affects approximately 75 million people in Europe, the United States, and Japan. In this context, the identification of specific microRNA (miRNA) signatures is an important step for new diagnostic and therapeutic approaches. The focus of interest on miRNAs as biomarkers came with new publications identifying free circulating extracellular miRNAs associated with various types of cancer. This study aimed to identify specific miRNAs in patients with osteoporotic fractures compared with nonosteoporotic fractures. For the array analysis, miRNAs were isolated from the serum of 20 patients with hip fractures, transcribed, and the samples were pooled into 10 osteoporotic and 10 nonosteoporotic specimens. With each pool of samples, human serum and plasma miRNA PCR arrays were performed, which are able to identify 83 different miRNAs. Subsequently, a separate validation analysis of each miRNA found to be regulated in the array followed with miRNA samples isolated from the serum of 30 osteoporotic and 30 nonosteoporotic patients and miRNA samples isolated from the bone tissue of 20 osteoporotic and 20 nonosteoporotic patients. With the validation analysis of the regulated miRNAs, we identified 9 miRNAs, namely miR-21, miR-23a, miR-24, miR-93, miR-100, miR-122a, miR-124a, miR-125b, and miR-148a, that were significantly upregulated in the serum of patients with osteoporosis. In the bone tissue of osteoporotic patients, we identified that miR-21, miR-23a, miR-24, miR-25, miR-100, and miR-125b displayed a significantly higher expression. A total of 5 miRNAs display an upregulation both in serum and bone tissue. This study reveals an important role for several miRNAs in osteoporotic patients and suggested that they may be used as biomarkers for diagnostic purposes and may be a target for treating bone loss and optimizing fracture healing in osteoporotic patients

Functional and Radiologic Outcomes of Degenerative Versus Traumatic Full-Thickness Rotator Cuff Tears Involving the Supraspinatus Tendon.

BACKGROUND Arthroscopic rotator cuff repair (ARCR) is among the most commonly performed orthopaedic procedures. Several factors-including age, sex, and tear severity-have been identified as predictors for outcome after repair. The influence of the tear etiology on functional and structural outcome remains controversial. PURPOSE To investigate the influence of tear etiology (degenerative vs traumatic) on functional and structural outcomes in patients with supraspinatus tendon tears. STUDY DESIGN Cohort study; Level of evidence, 2. METHODS Patients undergoing ARCR from 19 centers were prospectively enrolled between June 2020 and November 2021. Full-thickness, nonmassive tears involving the supraspinatus tendon were included. Tears were classified as degenerative (chronic shoulder pain, no history of trauma) or traumatic (acute, traumatic onset, no previous shoulder pain). Range of motion, strength, the Subjective Shoulder Value, the Oxford Shoulder Score (OSS), and the Constant-Murley Score (CMS) were assessed before (baseline) and 6 and 12 months after ARCR. The Subjective Shoulder Value and the OSS were also determined at the 24-month follow-up. Repair integrity after 12 months was documented, as well as additional surgeries up to the 24-month follow-up. Tear groups were compared using mixed models adjusted for potential confounding effects. RESULTS From a cohort of 973 consecutive patients, 421 patients (degenerative tear, n = 230; traumatic tear, n = 191) met the inclusion criteria. The traumatic tear group had lower mean baseline OSS and CMS scores but significantly greater score changes 12 months after ARCR (OSS, 18 [SD, 8]; CMS, 34 [SD,18] vs degenerative: OSS, 15 [SD, 8]; CMS, 22 [SD, 15]) (P < .001) and significantly higher 12-month overall scores (OSS, 44 [SD, 5]; CMS, 79 [SD, 9] vs degenerative: OSS, 42 [SD, 7]; CMS, 76 [SD, 12]) (P≤ .006). At the 24-month follow-up, neither the OSS (degenerative, 44 [SD, 6]; traumatic, 45 [SD, 6]; P = .346) nor the rates of repair failure (degenerative, 14 [6.1%]; traumatic 12 [6.3%]; P = .934) and additional surgeries (7 [3%]; 7 [3.7%]; P = .723) differed between groups. CONCLUSION Patients with degenerative and traumatic full-thickness supraspinatus tendon tears who had ARCR show satisfactory short-term functional results. Although patients with traumatic tears have lower baseline functional scores, they rehabilitate over time and show comparable clinical results 1 year after ARCR. Similarly, degenerative and traumatic rotator cuff tears show comparable structural outcomes, which suggests that degenerated tendons retain healing potential

Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

BACKGROUND: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia. METHODS: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion. DISCUSSION: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia. TRIAL REGISTRATION: NCT03162653, www.ClinicalTrials.gov , May 22, 2017.status: publishe

Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study

Introduction In the field of arthroscopic rotator cuff repair (ARCR), reporting standards of published studies differ dramatically, notably concerning adverse events (AEs). In addition, prognostic studies are overall methodologically poor, based on small data sets and explore only limited numbers of influencing factors. We aim to develop prognostic models for individual ARCR patients, primarily for the patient-reported assessment of shoulder function (Oxford Shoulder Score (OSS)) and the occurrence of shoulder stiffness 6 months after surgery. We also aim to evaluate the use of a consensus core event set (CES) for AEs and validate a severity classification for these events, considering the patient’s perspective.Methods and analysis A cohort of 970 primary ARCR patients will be prospectively documented from several Swiss and German orthopaedic clinics up to 24 months postoperatively. Patient clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score). Tendon repair integrity status will be assessed by ultrasound at 12 months. Patient-reported questionnaires at 6, 12 and 24 months will determine functional scores (subjective shoulder value, OSS), anxiety and depression scores, working status, sports activities, and quality of life (European Quality of Life 5 Dimensions 5 Level questionnaire). AEs will be documented according to a CES. Prognostic models will be developed using an internationally supported regression methodology. Multiple prognostic factors, including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity, concomitant local findings, and (post)operative management factors, will be investigated.Ethics and dissemination This project contributes to the development of personalised risk predictions for supporting the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registries. Ethical approval was obtained on 1 April 2020 from the lead ethics committee (EKNZ, Basel, Switzerland; ID: 2019-02076). All participants will provide informed written consent before enrolment in the study.Trial registration number NCT04321005.Protocol version Version 2 (13 December 2019)

Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): Study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Background: Perinatal asphyxia and resulting hypoxic-ischemic encephalopathy is a major cause of death and long-term disability in term born neonates. Up to 20,000 infants each year are affected by HIE in Europe and even more in regions with lower level of perinatal care. The only established therapy to improve outcome in these infants is therapeutic hypothermia. Allopurinol is a xanthine oxidase inhibitor that reduces the production of oxygen radicals as superoxide, which contributes to secondary energy failure and apoptosis in neurons and glial cells after reperfusion of hypoxic brain tissue and may further improve outcome if administered in addition to therapeutic hypothermia. Methods: This study on the effects of ALlopurinol in addition to hypothermia treatment for hypoxic-ischemic Brain Injury on Neurocognitive Outcome (ALBINO), is a European double-blinded randomized placebo-controlled parallel group multicenter trial (Phase III) to evaluate the effect of postnatal allopurinol administered in addition to standard of care (including therapeutic hypothermia if indicated) on the incidence of death and severe neurodevelopmental impairment at 24 months of age in newborns with perinatal hypoxic-ischemic insult and signs of potentially evolving encephalopathy. Allopurinol or placebo will be given in addition to therapeutic hypothermia (where indicated) to infants with a gestational age ≥ 36 weeks and a birth weight ≥ 2500 g, with severe perinatal asphyxia and potentially evolving encephalopathy. The primary endpoint of this study will be death or severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment at the age of two years. Effects on brain injury by magnetic resonance imaging and cerebral ultrasound, electric brain activity, concentrations of peroxidation products and S100B, will also be studied along with effects on heart function and pharmacokinetics of allopurinol after iv-infusion. Discussion: This trial will provide data to assess the efficacy and safety of early postnatal allopurinol in term infants with evolving hypoxic-ischemic encephalopathy. If proven efficacious and safe, allopurinol could become part of a neuroprotective pharmacological treatment strategy in addition to therapeutic hypothermia in children with perinatal asphyxia. Trial registration: NCT03162653, www.ClinicalTrials.gov, May 22, 2017