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PURPOSE: The purpose of this study was to determine the long-term consequences of trapeziectomy and ligament reconstruction and tendon interposition (LRTI) for trapeziometacarpal osteoarthritis in patients aged less than 56 years. METHODS: A retrospective study was performed to investigate the outcome of trapeziectomy and LRTI with a follow-up period of greater than 5 years in patients aged less than 56 years at the time of surgery. Patients completed the Disabilities of Arm, Shoulder, and Hand (DASH), the Patient-Rated Wrist Evaluation (PRWE), and a 10-point visual analog score for pain (VAS). Objective assessments included thumb opposition, palmar and radial abduction angles, and grip, lateral key, and thumb tip pinch strengths. Radiographic assessments of the thumb carpometacarpal joint were performed in three planes, and the trapezial space and trapezial space to metacarpal height ratios were calculated. RESULTS: Between January 2005 and December 2017, 105 patients were treated. Forty-eight patients with 58 thumbs returned for review. The mean patient age at the time of surgery was 52.5 years, and 96% of the patients were women. The mean follow-up period from surgery was 11 years. The mean VAS score was 1. A significant association was found between younger age at the time of surgery and increased proximal migration of the metacarpal, between high VAS pain scores and high PRWE and DASH scores, weak grip, lateral key pinch and thumb tip pinch strength, and Kapandji score, and between the follow-up period and increasing VAS pain, PRWE, and DASH scores. CONCLUSIONS: Trapeziectomy and LRTI are effective procedures for patients aged less than 56 years. The benefits of surgery should be balanced against the deterioration in the outcome measures of DASH and PRWE and increasing VAS scores with increasing intervals from surgery. TYPE OF STUDY/LEVEL EVIDENCE: Therapeutic IV.
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BACKGROUND: Pyogenic flexor tenosynovitis (PFT) is a common and severe hand infection. Patients who present early can be treated with intravenous antibiotics. OBJECTIVES: To determine whether PFT caused by animal bites and treated with antibiotics leads to a different outcome than other disease etiologies due to the extensive soft tissue insult and different bacterial flora. METHODS: We conducted a retrospective cohort study of 43 consecutive patients who presented with PFT between 2013 and 2020. The 10 patients who presented with PFT following an animal bite were compared to those who presented with PFT caused by any other etiology. RESULTS: Patients who were bitten pursued medical attention sooner: 1.9 ± 1.4 days compared with 5.3 ± 4.7 days (P = 0.001). Despite the quicker presentation, patients from the study group received similar antibiotic types and duration as controls. All patients were initially treated with intravenous antibiotics under surveillance of a hand surgeon. One patient (10%) from the study group and four controls (12%) were treated surgically (P = 1). Average follow-up was 17 ± 16 days. At the end of follow-up, one (10%) patient from the study group and three (9%) controls sustained mild range of motion limitation and one (3%) patient from the control group had moderate limitations (P = 0.855). CONCLUSIONS: Intravenous antibiotic treatment, combined with an intensive hand surgeon follow-up, is a viable option for the treatment of PFT caused by animal bites.
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Antibacterianos , Mordeduras e Picadas , Tenossinovite , Humanos , Antibacterianos/administração & dosagem , Antibacterianos/uso terapêutico , Tenossinovite/etiologia , Tenossinovite/tratamento farmacológico , Tenossinovite/microbiologia , Tenossinovite/terapia , Estudos Retrospectivos , Animais , Masculino , Feminino , Mordeduras e Picadas/complicações , Mordeduras e Picadas/tratamento farmacológico , Adulto , Pessoa de Meia-Idade , Resultado do Tratamento , Administração IntravenosaRESUMO
Techniques of minimally invasive bunion surgery have become increasingly popular in recent years. However, the learning curve involved in mastering these innovative techniques has not been described. To address this issue, a trained foot and ankle surgeon in a university hospital operated on 50 patients using the minimally invasive Chevron and Akin procedure over the course of 3 years, from January 2016 through December 2018. Surgery duration and x-ray exposure were documented. Results showed that surgery duration decreased from >2 hours in the first cases to a mean of â¼45 minutes in the third year. This learning curve plateaued by the 21st patient. The number of intraoperative fluoroscopy studies used decreased substantially over the first 27 surgeries, at which point the learning curve plateaued. In summary, it took about 27 procedures for an inexperienced surgeon to acquire the skill of performing minimally invasive Chevron and Akin osteotomy.
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Hallux Valgus , Curva de Aprendizado , Hallux Valgus/diagnóstico por imagem , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos , Osteotomia , Radiografia , Resultado do TratamentoRESUMO
BACKGROUND: Lateral epicondylitis is a tendinopathy of the common extensor origin at the elbow. When traditional conservative treatment fails, more effective therapies are needed. Vergenix Soft Tissue Repair (STR) Matrix (CollPlant Ltd., Ness-Ziona, Israel) is an injectable gel composed of cross-linked bioengineered recombinant human type I collagen combined with autologous platelet-rich plasma (STR/PRP). The complex forms a collagen-fibrin matrix that promotes cell migration and tissue repair. Based on positive outcomes from preclinical trials, this study is the first clinical trial of STR/PRP on tendinopathy. We hypothesized that STR/PRP would be a safe and effective treatment for lateral epicondylar tendinopathy. METHODS: Patients with chronic lateral epicondylitis underwent treatment with STR/PRP. Outcome assessment included grip strength, functional disability, and changes in sonographic tendon appearance for up to 6 months after treatment. RESULTS: The study enrolled 40 patients. No systemic or local severe adverse events were reported. Clinical evaluation revealed an improvement in the mean Patient-Rated Tennis Elbow Evaluation score from 64.8 before treatment and showed a 59% reduction at 6 months. The 12-Item Short-Form Health Survey questionnaire showed improvement from a mean score of 30.7 to 37.7 at the final follow-up. Grip strength increased from 28.8 kg at baseline to 36.8 kg at 6 months. Improvements in sonographic tendon appearance were evident among 68% of patients. CONCLUSION: STR/PRP is a safe treatment that effectively induces clinically significant improvements in elbow symptoms and general well-being as well as objective measures of strength and imaging of the common extensor tendon within 6 months of treatment of elbow tendinopathy recalcitrant to standard treatments.
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Colágeno Tipo I/administração & dosagem , Plasma Rico em Plaquetas , Cotovelo de Tenista/terapia , Doença Crônica , Feminino , Géis , Força da Mão , Nível de Saúde , Inquéritos Epidemiológicos , Humanos , Masculino , Proteínas Recombinantes/efeitos adversos , Tendões/diagnóstico por imagem , Cotovelo de Tenista/diagnóstico por imagem , Cotovelo de Tenista/fisiopatologia , Alicerces Teciduais , Resultado do Tratamento , UltrassonografiaRESUMO
PURPOSE: The primary purpose of the study was to investigate if and how patellar bone tracer uptake (BTU) distribution in SPECT/CT is influenced by patellar resurfacing and the position of femoral and tibial TKA component position. METHODS: A total of 104 knees of 103 consecutive patients who underwent primary TKA were prospectively investigated. Primary patellar resurfacing was done in 40 knees while 64 had a TKA without patellar resurfacing. All patients underwent clinical assessment using the knee society score (KSS) and standardized radiographs and Tc-99m-HDP-SPECT/CT before and 12 and 24 months after TKA. Measurements of BTU including intensity and anatomical distribution pattern in eight different patellar regions were performed. Tibial and femoral TKA component position was assessed from 3D reconstructed CT data. Patellar height, thickness and tilt were measured and the distance between the tibial tuberosity and the trochlear groove (TT-TG) was measured. Univariate analysis was performed to identify differences between the two groups (p < 0.05). RESULTS: Significantly higher BTU was found in the anterior, non-articular, areas of the patella in patients who underwent patellar resurfacing (p < 0.05). The BTU pattern was similar between the groups, as the maximal uptake in both groups was seen in the superior posterior parts and the minimal uptake was seen in the inferior anterior parts. The mean postoperative KSS was significantly higher in the unresurfaced group after 12 months (p < 0.05), but with no significant difference after 24 months. CONCLUSIONS: Based on the findings of the present study, patellar resurfacing is related to significantly higher BTU in the anterior parts of the patella and lower clinical outcomes. In light of these results, routine patellar resurfacing as part of a primary TKA might be reevaluated. SPECT/CT enables a precise localization of the BTU and might be considered as the ideal imaging modality for evaluation and investigate of patellofemoral disorders after TKA.
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Artroplastia do Joelho/efeitos adversos , Fêmur/diagnóstico por imagem , Articulação do Joelho/diagnóstico por imagem , Osteoartrite do Joelho/diagnóstico por imagem , Patela/diagnóstico por imagem , Tíbia/diagnóstico por imagem , Idoso , Artroplastia do Joelho/métodos , Feminino , Fêmur/fisiopatologia , Fêmur/cirurgia , Humanos , Articulação do Joelho/fisiopatologia , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/fisiopatologia , Osteoartrite do Joelho/cirurgia , Patela/fisiopatologia , Patela/cirurgia , Tomografia Computadorizada com Tomografia Computadorizada de Emissão de Fóton Único , Tíbia/fisiopatologia , Tíbia/cirurgiaRESUMO
PURPOSE: The optimal coronal alignment is still under debate. However, in most of the studies, alignment was only assessed using radiographs, which are not accurate enough for assessment of tibial and femoral TKA position. The primary purpose of this study was to assess the relationship between coronal TKA alignment using 3D-reconstructed CTs and clinical outcome in patients with preoperative varus in comparison with patients with natural or valgus deformity. It was the hypothesis that neutral limb alignment shows a better outcome after TKA. METHODS: Prospectively collected data of 38 patients were included. The clinical and radiological follow-up was 24 months. The patients were grouped into two groups with regard to their preoperative limb alignment. Group A (varus) consisted of 21 patients with preoperative varus of 3° or more, while group B (non-varus) consisted of 17 patients with neutral (- 3 < 0 > + 3) or valgus alignment (> + 3). For assessment of TKA component position and orientation, 3D-reconstructed CT was used. The measurements of the deviation from the whole limb mechanical axis (HKA angle) and the joint line alignment in the femoral (mLDFA) and the tibial side (MPTA) were assessed in the preoperative leg as well as during follow-up after TKA. For clinical outcome assessment, the Knee Society Score (KSS) was used at 1 and 2 years postoperatively. Correlation between KSS score and each variable was done using a linear and quadratic regression model (p < 0.05). RESULTS: The mean postoperative HKA angle was - 1.3 (varus) in the varus group and + 1.4 (valgus) in the non-varus group. Overall, significant correlations between the preoperative and postoperative alignments were found. In the preoperatively non-varus group, a highly significant correlation was found between neutral limb alignment (HKA = 0° ± 3°) and higher KSS (r 2 = 0.74, p = 0.00). In the varus group, no correlation was found between the postoperative whole limb alignment and the components' position in the coronal plane to KSS score. CONCLUSION: A significant correlation was found between neutral limb alignment and higher KSS only in patients with preoperative non-varus alignment. The concept of constitutional varus alignment is still under debate. Moreover, it appears that one should aim for a more individualized, alignment target based on the individual knee morphotype. LEVEL OF EVIDENCE: Diagnostic study, Level II.
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Artroplastia do Joelho/métodos , Mau Alinhamento Ósseo/diagnóstico por imagem , Articulação do Joelho/cirurgia , Osteoartrite do Joelho/cirurgia , Idoso , Idoso de 80 Anos ou mais , Mau Alinhamento Ósseo/prevenção & controle , Mau Alinhamento Ósseo/cirurgia , Feminino , Fêmur/cirurgia , Humanos , Imageamento Tridimensional , Joelho/cirurgia , Prótese do Joelho , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tíbia/cirurgia , Tomografia Computadorizada por Raios XRESUMO
PURPOSE: The aim of this study was to evaluate femoral and tibial as well as whole leg coronal TKA alignment using 3D-reconstructed CTs and to assess the relationship of coronal TKA alignment and clinical outcome in a large prospective series of patients. It was hypothesized that a coronal deviation of TKA position and leg alignment from the mechanical axis is correlated with poorer patients' outcome after TKA. METHODS: A total of 81 consecutive patients who underwent primary TKA were prospectively included. The patient's demographics such as age, gender and time from primary TKA were noted. All patients underwent clinical and radiological examination including standardized radiographs (anteroposterior and lateral weight-bearing, patellar skyline view) and CT as part of their postoperative follow-up. For assessment of TKA component position and orientation 3D-reconstructed CT was used. For clinical outcome scoring the Knee Society Score (KSS) was used at 1 and 2 years postoperatively. Linear and quadratic regression models were used to test for correlations between alignment variables and KSS (p < .05). RESULTS: The mean Knee Society Score was 181 ± 28 (range 52-200) 2 years postoperatively, while 78% of the patients were completely pain free and 22% had some persisting pain interfering with their daily activities. The mean mechanical whole limb alignment (HKA angle), femoral component alignment and tibial component alignment were 0°, 0.1° and -0.7°, respectively. The component position parameters, as well as the whole limb alignment measurements, did not show any statistically significant correlation with the KSS, after 1 and 2 years postoperatively. CONCLUSION: In this prospective study, using 3D-CT to measure the component position, the postoperative outcome was not influenced by coronal TKA component position as well as the whole leg alignment. The findings challenge the current target of neutral coronal alignment and point towards a more individualized mechanical alignment target. LEVEL OF EVIDENCE: Prognostic study, Level I.
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Artroplastia do Joelho , Imageamento Tridimensional , Articulação do Joelho/cirurgia , Osteoartrite do Joelho/cirurgia , Tomografia Computadorizada por Raios X , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Fêmur/cirurgia , Humanos , Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Medição da Dor , Patela/cirurgia , Estudos Prospectivos , Radiografia , Índice de Gravidade de Doença , Tíbia/cirurgia , Resultado do TratamentoRESUMO
PURPOSE: As patellar tracking and loading is influenced by tibial tuberosity and trochlear groove (TT-TG) distance, patellar height, thickness and tilt as well as TKA component position, it was our hypothesis that these parameters significantly correlate with patellar BTU intensity and localization in SPECT/CT. The purpose of the study was to investigate whether TKA component position as well as the height, thickness and tilt of the unresurfaced patella influences the intensity and the distribution pattern of BTU in SPECT/CT. METHODS: A total of 62 consecutive patients who underwent primary TKA without patellar resurfacing were prospectively included. Demographic data such as age, gender, side and type of primary TKA were noted. All patients underwent clinical and radiological examination in a specialized knee clinic, including standardized radiographs (anterior-posterior and lateral weight bearing, patellar skyline view) and Tc-99m-HDP-SPECT/CT before, 12 and 24 months after TKA. SPECT/CT images were analysed on 3D reconstructed images. Rotational, sagittal and coronal position of the tibial and femoral TKA components was assessed using a previously validated analysis software. Measurements of BTU including intensity and anatomical distribution pattern were also performed from 3D data. The patellar height, thickness and tilt were measured, and the distance between TT and TG was measured using axial CT images. Univariate analysis was performed to identify any correlations between BTU and TKA component position and patellar measurements (p < 0.05). RESULTS: The highest median BTU was measured in the superior posterior parts of the patella. A statistically significant correlation was found between valgus alignment of the femoral TKA and increased BTU at the lateral patellar regions (p < 0.05). External rotation of the tibial TKA correlated with increased BTU at the lateral superior joint adjacent part (p < 0.05). No correlation was found between the tibial TKA position (varus-valgus, anterior and posterior slope), TT-TG distance, patellar height and patellar BTU values. CONCLUSIONS: A significant correlation of increased patellar BTU was found with femoral valgus TKA alignment. These findings highlight the importance of femoral TKA position in coronal plane with regard to post-operative patellar tracking. Moreover, these facts might explain anterior knee pain in unhappy TKA with femoral valgus alignment. LEVEL OF EVIDENCE: Diagnostic study, Level II.
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Artroplastia do Joelho/instrumentação , Artroplastia do Joelho/métodos , Patela/anatomia & histologia , Patela/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Artralgia/etiologia , Artroplastia do Joelho/efeitos adversos , Feminino , Fêmur/anatomia & histologia , Fêmur/diagnóstico por imagem , Fêmur/cirurgia , Humanos , Imageamento Tridimensional , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Patela/cirurgia , Complicações Pós-Operatórias , Rotação , Tomografia Computadorizada com Tomografia Computadorizada de Emissão de Fóton Único , Medronato de Tecnécio Tc 99m/análogos & derivados , Tíbia/diagnóstico por imagem , Tíbia/cirurgiaRESUMO
PURPOSE: A variety of bone void filling materials and methods are available in opening medial wedge HTO (OWHTO). The pertinent question revolves around if and when bone void fillers are needed. The primary purpose of this study was to systematically review outcomes and complications after OWHTO with and without the use of bone void fillers. METHODS: The EMBASE, PubMed\MEDLINE, Cochrane Library and Google Scholar databases were searched to identify articles that reported OWHTO results using different bone void fillers until March 2016. Only articles reporting the exact bone void filler type, the opening gap size and the fixation method were included. The extracted data included the study design, demographic data, the radiological and clinical results and complication rates. Outcomes were analysed with regard to bone void filler type, and comparison was made between the groups (allograft, autograft, synthetic bone void filler and OWHTO without bone void filling). RESULTS: Twenty-two articles reporting the results of 1421 OWHTO met the inclusion criteria. In total, 647 osteotomies were completed with allogeneic graft as bone void filler, 367 with synthetic materials, 199 with autograft and 208 without any bone void filling material. The maximum opening gap size was similar in all groups with mean of 9.8 mm (range 4-17.5 mm). Locking plate fixation was used in 90 % of the osteotomies that were completed without bone void filler, while all allograft cases and more then 90 % of the autograft cases were done with non-locking systems. The highest rates of non-union (1.1 %) were seen in the synthetic group, compared to 0.5 % in the all the other groups. CONCLUSIONS: This systematic review showed no definitive advantages for OWHTO with any bone void filler in terms of union rates and loss of correction. Moreover, the use of autografts or allografts showed more favourable outcomes than synthetic bone substitutes. OWHTO with gaps smaller then 10 mm and rigid fixation might be successfully managed without bone grafting. However, when bone grafting is needed, autograft bone provides higher rates of clinical and radiographic union. The use of synthetic bone substitutes in OWHTO cannot be recommended. LEVEL OF EVIDENCE: III.
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Placas Ósseas , Substitutos Ósseos/uso terapêutico , Transplante Ósseo/métodos , Osteoartrite do Joelho/cirurgia , Osteotomia/métodos , Tíbia/cirurgia , Osso e Ossos , Humanos , Radiografia , Transplante Autólogo , Transplante HomólogoRESUMO
PURPOSE: This study explores the use of ultrasound-guided Hyaluronic Acid (HA) injections for Insertional Achilles Tendinopathy (IAT). METHODS: A cohort of 15 ankles diagnosed with IAT received three weekly ultrasound-guided HA injections. The Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire scored the severity of symptoms and functional impairment before treatment, and at one and six months post-treatment. RESULTS: Significant improvement was observed in VISA-A scores post-treatment, rising from an average baseline of 34.8 ± 15.2 (11-63) to 53.6 ± 20.9 (15-77) after one month, and then to 50.7 ± 18.6 (20-75) after six months. No adverse reactions were noted, underscoring the safety of the intervention. CONCLUSION: The pilot study presents HA injections as a potentially effective treatment for IAT, while interpretation of these findings must take into account the variability in results, indicating a range of patient responses. It encourages further research to confirm these findings and to explore HA's full potential in managing IAT, despite the limitations of a small sample size and lack of control group.
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Tendão do Calcâneo , Esportes , Tendinopatia , Humanos , Ácido Hialurônico/uso terapêutico , Projetos Piloto , Tendinopatia/diagnóstico por imagem , Tendinopatia/tratamento farmacológico , Resultado do TratamentoRESUMO
Background: Symptomatic distal interphalangeal (DIP) joint arthritis is frequently treated by arthrodesis, though DIP arthroplasty has been reported as a treatment option since 1977. This study reviews the current evidence on DIP joint arthroplasty for the treatment of arthritis refractory to non-operative management. Methods: A systematic search of PubMed, MEDLINE and Embase databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Risk of bias was assessed using the ROBINS-I tool. Results: The search yielded 55 records, of which six studies were included in the narrative review. All the included studies were of level IV evidence (case series or cohort studies). DIP arthroplasty was effective in relieving pain and reducing subsequent dysfunction. The average total arc of motion was 30°-40° but with an extension lag of 10°-15°. The overall complication rate was 15% with a re-operation rate of 8%. Joint instability (incidence of 2.5%) and infection (incidence of 2.1%) were the most common complications, while implant fracture was seen in 1% of cases. Joints that failed after DIP arthroplasty were salvaged by DIP arthrodesis. Conclusions: DIP arthroplasty is an effective treatment for painful arthritis but with a complication rate of 15%. Its main advantage over arthrodesis is the preservation of DIP motion. However, due to the limited high-quality evidence available, its use should be limited to circumstances where there is a desire or vocational need to maintain motion at the DIP joint. Level of Evidence: Level V (Therapeutic).
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Background: Syndactyly is one of the commonly encountered congenital hand anomalies. However, there are no strict guidelines regarding the timing of surgical release. The aim of this study was to investigate the age and factors associated with syndactyly release in the United States. Methods: A retrospective analysis of the California and Florida State Ambulatory Surgery and Services Databases for patients aged 18 years or younger who underwent syndactyly release surgery between 2005 and 2011 was performed. Demographic data that included the age at release, gender, race and primary payor (insurance) was collected. A sub-analysis was performed to compare the demographic characteristics between those patients undergoing syndactyly release before 5 years of age ('Early Release') and at (of after) 5 years ('Late Release'). Results: A total of 2,280 children (68% male, 43% Caucasian) were identified. The mean age of syndactyly release was 3.6 years, and 72.9% of patients underwent release before the age of 5 years. A significantly larger proportion of females (p = 0.002), and Hispanics and African Americans (p = 0.024), underwent late release compared to early release. Additionally, a significantly higher percentage of patients undergoing late release utilised private insurance (p = 0.005). However, the actual differences in gender, race and primary payor were small. Conclusion: The majority of syndactyly releases were performed before school age, which is the primary goal in the management of syndactyly. While gender and racial disparities in the surgical treatment of syndactyly may exist, the differences in the present study were relatively small. Level of Evidence: Level III (Therapeutic).
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Deformidades Congênitas da Mão , Sindactilia , Criança , Pré-Escolar , Bases de Dados Factuais , Feminino , Humanos , Masculino , Estudos Retrospectivos , Sindactilia/cirurgia , Estados Unidos , População BrancaRESUMO
BACKGROUND: Foot ulcers are a common complication in diabetic patients. Mild callus formation due to a plantar pressure can lead to an ulcer formation with potentially hazardous sequelae. Eliminating the pressure from the ulcer is essential for a proper healing process. Proximal derotation phalangeal osteotomy is a relatively simple procedure that can redistribute the planter pressure points over the hallux. METHODS: Thirteen patients underwent proximal derotation phalangeal osteotomy to relieve the bony pressure causing an ulcer in the first toe, which was refractory to non-operative treatment. Twelve patients had diabetes type 2 and one had Charcot-Marie-Tooth disease. RESULTS: Ulcers were completely resolved in all 13 patients in an average time of 4.3 (range 2-8) weeks. Four patients (31%) had mild complications that resolved well. No further surgery was required at 1-year follow-up. CONCLUSION: Proximal derotation phalangeal osteotomy enabled ulcer healing in refractory cases. LEVEL OF EVIDENCE: Level III retrospective study.
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OBJECTIVE: Osteoarthritis (OA) is a widespread degenerative joint disease leading to progressive loss of function and pain. Available treatments do not provide long-term relief or improvement. This study aimed to assess the safety and efficacy of a novel intra articular supplement, made of high molecular-weight hyaluronic acid (HA) uniquely conjugated to either purified (RegenoGel) or autologous plasma-derived fibrinogen (RegenoGel-OSP), as a long-term treatment for knee OA. METHODS: Sixty-seven consecutive participants (mean age 67.26 ± 7 years) with symptomatic OA were randomly assigned to receive intraarticular injections of either RegenoGel, RegenoGel-OSP or saline solution (placebo). The active treatment groups received a second, repeat injection of the corresponding treatment at the 3-month evaluation, at which time, the placebo group was divided into two subgroups, one receiving RegenoGel and the other receiving RegenoGel-OSP. The OA symptoms were assessed by VAS, WOMAC, and IKDC questionnaires at baseline and at 1, 3, 4, and 6 months following the first injection. OA-related quality of life was evaluated by the SF-12 survey. RESULTS: Our preliminary data suggests that both fibrin-HA formulations have positive effects on OA symptoms for all assessed parameters with the most prominent trend for reduction in OA-associated pain. Pooled data analysis of RegenoGel and RegenoGel-OSP shows significantly improved VAS scores compared to placebo at three months after the first injection, and sustained for another three months after the second injection. Both RegenoGel, RegenoGel-OSP had an excellent safety profile. CONCLUSIONS: Interim analysis results indicate that RegenoGel and RegenoGel-OSP are safe and are potentially effective for at least six months in alleviating pain and symptoms of knee OA.
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BACKGROUND: There is no consensus regarding the proper radiographic protocol following closed or open reduction and internal fixation for intertrochanteric femoral fractures. The objective of this study was to assess the role of early postoperative imaging studies when deciding about weight bear limitations and reoperations. METHODS: A prospective cohort study of 100 patients (26 men and 74 women, at a mean age of 79.8 years) treated by closed or open reduction and internal fixation for AO31A fractures was conducted. According to the AO classification, there were 25 cases of 31A1, 54 cases of 31A2, and 21 cases of 31A3. For every patient, the intraoperative fluoroscopy studies were recorded and post-operative radiograms were taken during the first week. Excluded were patients for whom the early X-rays were clinically indicated. The intraoperative AP and axial fluoroscopy studies were compared with the radiograms taken during the first post-operative week. The investigators compared the decisions regarding weight-bearing limitations and the need for re-operation before and after conducting the radiograms. RESULTS: The early post-operative imaging studies did not change weight-bearing limitations nor did they lead to consecutive surgical treatments. CONCLUSIONS: Unless indicated by physical examination, there is no value to routine post-operative radiograms within the first few days after closed reduction and internal fixation of intertrochanteric femoral fractures with regard to weight-bearing limitations and re-operation decisions. TRIAL REGISTRATION: Identifier: NCT02868125 .