272 research outputs found

    Restoration of Native Leg Length After Opening-Wedge High Tibial Osteotomy: An Intraindividual Analysis

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    BACKGROUND Opening-wedge high tibial osteotomy (OWHTO) has been shown to significantly increase leg length, especially in patients with large varus deformity. Thus, the current literature recommends closing-wedge high tibial osteotomy to correct malalignment in these patients to prevent postoperative leg length discrepancy. However, potential preoperative leg length discrepancy has not been considered yet. HYPOTHESIS It was hypothesized that patients have a decreased preoperative length of the involved leg compared with the contralateral side and that OWHTO would subsequently restore native leg length. STUDY DESIGN Case series; Level of evidence, 4. METHODS Included were 67 patients who underwent OWHTO for unilateral medial compartment knee osteoarthritis and who received full leg length assessment pre- and postoperatively. Patients with varus or valgus deformity (>3°) of the contralateral side were excluded. A musculoskeletal radiologist assessed imaging for the mechanical axis, full leg length, and tibial length of the involved and contralateral lower extremity. Statistical analysis determined the pre- and postoperative leg length discrepancy and the influence of the mechanical axis. RESULTS Most patients (62.7%) had a decreased length of the involved leg, with a mean preoperative mechanical axis of 5.0° ± 2.9°. Length discrepancy averaged -2.2 ± 5.8 mm, indicating a shortened involved extremity (P = .003). OWHTO significantly increased the mean lengths of the tibia and lower limb by 3.6 ± 2.9 and 4.4 ± 4.7 mm (P < .001), leading to a postoperative tibial and full leg length discrepancy of 2.8 ± 4.3 mm and 2.2 ± 7.3 mm (P < .001 and P = .017, respectively). Preoperative leg length discrepancy was significantly correlated with the preoperative mechanical axis of the involved limb (r = 0.292; P = .016), and the amount of correction was significantly associated with leg lengthening after OWHTO (r = 0.319; P = .009). Patients with a varus deformity of ≥6.5° (n = 14) had a preoperative length discrepancy of -4.5 ± 1.6 mm (P < .001) that was reduced to 1.8 ± 3.5 mm (P = .08). CONCLUSION Patients undergoing OWHTO have a preoperative leg length discrepancy that is directly associated with the varus deformity of the involved extremity. As OWHTO significantly increases leg length, restoration of native leg length can be achieved particularly in patients with large varus deformity

    First experiences with the implementation of the European standard EN 62304 on medical device software for the quality assurance of a radiotherapy unit

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    BACKGROUND: According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). METHODS: The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. RESULTS: The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. CONCLUSIONS: The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers

    Correlation of Postoperative Imaging With MRI and Clinical Outcome After Cartilage Repair of the Ankle: A Systematic Review and Meta-analysis

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    BACKGROUND Magnetic resonance imaging (MRI) is commonly used for evaluation of ankle cartilage repair, yet its association with clinical outcome is controversial. This study analyzes the correlation between MRI and clinical outcome after cartilage repair of the talus including bone marrow stimulation, cell-based techniques, as well as restoration with allo- or autografting. METHODS A systematic search was performed in MEDLINE, Embase, and Cochrane Collaboration. Articles were screened for correlation of MRI and clinical outcome. Guidelines of Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) were used. Chi-square test and regression analysis were performed to identify variables that determine correlation between clinical and radiologic outcome. RESULTS Of 2687 articles, a total of 43 studies (total 1212 cases) were included with a mean Coleman score of 57 (range, 33-70). Overall, 93% were case series, and 5% were retrospective and 2% prospective cohort studies. Associations between clinical outcome and ≥1 imaging variable were found in 21 studies (49%). Of 24 studies (56%) using the composite magnetic resonance observation of cartilage repair tissue (MOCART) score, 7 (29%) reported a correlation of the composite score with clinical outcome. Defect fill was associated with clinical outcome in 5 studies (12%), and 5 studies (50%) reported a correlation of T2 mapping and clinical outcome. Advanced age, shorter follow-up, and larger study size were associated with established correlation between clinical and radiographic outcome (P = .021, P = .028, and P = .033). CONCLUSION Interpreting MRI in prediction of clinical outcome in ankle cartilage repair remains challenging; however, it seems to hold some value in reflecting clinical outcome in patients with advanced age and/or at a shorter follow-up. Yet, further research is warranted to optimize postoperative MRI protocols and assessments allowing for a more comprehensive repair tissue evaluation, which eventually reflect clinical outcome in patients after cartilage repair of the ankle.Level of Evidence: Level III, systematic review and meta-analysis

    Association of Subchondral Changes With Age and Clinical Outcome in Patients With Osteochondral Fractures in the Knee: MRI Analysis at 1 to 10 Years Postoperatively

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    Background Predictive factors influencing outcomes after surgical fixation of osteochondral fractures (OCFs) in the knee, particularly time between injury and surgery, have not been determined. Purpose To report imaging and clinical outcomes after OCF fixation and to assess the association between clinical scores and patient characteristics, lesion morphology, and appearance on magnetic resonance imaging (MRI) scans. Study Design Case series; Level of evidence, 4. Methods We assessed the clinical and imaging outcomes of 19 patients after screw fixation for OCFs in the knee at a minimum follow-up of 1 year. Patient characteristics, lesion morphology, and time from trauma to surgery were reviewed for each patient. At final follow-up, patients completed a 100-point visual analog scale (VAS) for pain, Tegner activity scale, Knee injury and Osteoarthritis Outcome Score (KOOS), and patient satisfaction survey. Postoperative MRI scans were assessed using the MOCART (magnetic resonance observation of cartilage repair tissue), Osteochondral Allograft MRI Scoring System, and bone marrow edema (BME) size. Results The mean patient age at surgery was 21.3 ± 11.4 years, and the median time from trauma to surgery was 10 days (range, 0-143 days). The refixed OCF fragment failed in 1 (5.3%) patient on the lateral condyle at 15 months postoperatively. The mean follow-up for the remaining 18 patients was 4.7 ± 3.2 years, and postoperative outcomes were as follows: VAS pain score, 9.5 ± 17.9; Tegner score, 4.8 ± 2.3; KOOS-Pain, 85.9 ± 17.6, KOOS-Symptoms, 76.4 ± 16.1; KOOS-Activities of Daily Living, 90.3 ± 19.0; KOOS-Sport, 74.4 ± 25.4; and KOOS-Quality of Life, 55.9 ± 24.7. Overall, 84.2% were satisfied or very satisfied with outcomes. Patient age was significantly associated with KOOS subscale scores and subchondral imaging parameters including BME and presence of subchondral cysts, which in turn were the only imaging variables linked to clinical outcomes (P < .05). Time from injury to surgery was not correlated with clinical or imaging outcomes. Conclusion Fixation of OCFs yielded acceptable clinical and imaging outcomes at a mean 5-year follow-up with seemingly little influence of delayed surgical treatment. Postoperative subchondral changes were significantly associated with clinical outcomes and were linked to patient age at surgery

    Registration based assessment of femoral torsion for rotational osteotomies based on the contralateral anatomy

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    BACKGROUND Computer-assisted techniques for surgical treatment of femoral deformities have become increasingly important. In state-of-the-art 3D deformity assessments, the contralateral side is used as template for correction as it commonly represents normal anatomy. Contributing to this, an iterative closest point (ICP) algorithm is used for registration. However, the anatomical sections of the femur with idiosyncratic features, which allow for a consistent deformity assessment with ICP algorithms being unknown. Furthermore, if there is a side-to-side difference, this is not considered in error quantification. The aim of this study was to analyze the influence and value of the different sections of the femur in 3D assessment of femoral deformities based on the contralateral anatomy. MATERIAL AND METHODS 3D triangular surface models were created from CT of 100 paired femurs (50 cadavers) without pathological anatomy. The femurs were divided into sections of eponymous anatomy of a predefined percentage of the whole femoral length. A surface registration algorithm was applied to superimpose the ipsilateral on the contralateral side. We evaluated 3D femoral contralateral registration (FCR) errors, defined as difference in 3D rotation of the respective femoral section before and after registration to the contralateral side. To compare this method, we quantified the landmark-based femoral torsion (LB FT). This was defined as the intra-individual difference in overall femoral torsion using with a landmark-based method. RESULTS Contralateral rotational deviation ranged from 0° to 9.3° of the assessed femoral sections, depending on the section. Among the sections, the FCR error using the proximal diaphyseal area for registration was larger than any other sectional error. A combination of the lesser trochanter and the proximal diaphyseal area showed the smallest error. The LB FT error was significantly larger than any sectional error (p < 0.001). CONCLUSION We demonstrated that if the contralateral femur is used as reconstruction template, the built-in errors with the registration-based approach are smaller than the intraindividual difference of the femoral torsion between both sides. The errors are depending on the section and their idiosyncratic features used for registration. For rotational osteotomies a combination of the lesser trochanter and the proximal diaphyseal area sections seems to allow for a reconstruction with a minimal error

    Epidemiology of Traumatic Posterior Hip Instability in the National Football League

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    BACKGROUND There is a paucity of literature regarding injury incidence, mechanism, and return to play in National Football League (NFL) players who have sustained traumatic posterior hip instability. PURPOSE To describe the incidence of traumatic posterior hip instability and the rate of return to play in NFL players across 18 seasons. STUDY DESIGN Descriptive epidemiology study. METHODS We retrospectively assessed all traumatic posterior hip dislocations/subluxations that occurred during football-related activities in the NFL seasons from 2000 through 2017. Player demographics and injury data (injury mechanism, season of injury, treatment, days missed, and return to play time) were collected from all 32 NFL teams prospectively through a leaguewide electronic health record system. Descriptive statistics are presented. RESULTS Across the 18 NFL seasons, 16 posterior hip instability injuries in 14 players were reported, with a maximum incidence of 4 (25%) in 2013. Posterior hip instability was predominantly sustained by offensive players (64.3%), with tight ends being the most affected (31.3%). Half of the injuries occurred during the regular season, 43.8% in the preseason, and 6.2% in the offseason. Of all injuries, 37.5% were noncontact, while 56.3% involved contact (direct or indirect), and 6.2% were of unknown mechanism. Among noncontact injuries, 66.7% occurred during cutting and change of direction while sprinting. The time of return to full participation was documented for 11 of the 16 reported injuries (68.8%); among them, the mean time loss was 136.7 ± 83.8 days-143.3 ± 99.6 days if the player underwent surgery (n = 4) and 116.7 ± 76.2 days missed by players without surgery (n = 6)-the treatment modality was unknown in 1 player. CONCLUSION Although the incidence of traumatic posterior hip instability during the study period was low, all injured athletes missed time from football activities and competitions. Injuries that required surgery led to more missed time than those that did not. Ongoing research to understand risk factors and mechanisms of this injury, in conjunction with improvements to prevention and rehabilitation protocols, is necessary to ensure the safety of professional American football players

    Inter- and intraobserver reliability of the MTM-classification for proximal humeral fractures: A prospective study

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    <p>Abstract</p> <p>Background</p> <p>A precise modular topographic-morphological (MTM) classification for proximal humeral fractures may address current classification problems. The classification was developed to evaluate whether a very detailed classification exceeding the analysis of fractured parts may be a valuable tool.</p> <p>Methods</p> <p>Three observers classified plain radiographs of 22 fractures using both a simple version (fracture displacement, number of parts) and an extensive version (individual topographic fracture type and morphology) of the MTM classification. Kappa-statistics were used to determine reliability.</p> <p>Results</p> <p>An acceptable reliability was found for the simple version classifying fracture displacement and fractured main parts. Fair interobserver agreement was found for the extensive version with individual topographic fracture type and morphology.</p> <p>Conclusion</p> <p>Although the MTM-classification covers a wide spectrum of fracture types, our results indicate that the precise topographic and morphological description is not delivering reproducible results. Therefore, simplicity in fracture classification may be more useful than extensive approaches, which are not adequately reliable to address current classification problems.</p
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