ABSTRACT
BACKGROUND: Partial-thickness rotator cuff tears treated with an isolated bioinductive repair (IBR) in lieu of a completion-and-repair have shown complete healing. This treatment option is afforded by the remaining tendon's structural integrity, which is similar to that present in small/medium full-thickness tears (FTTs) when the rotator cable remains intact. This randomized controlled trial (RCT) investigated whether an IBR for small/medium FTTs resulted in superior healing and patient-reported outcomes (PROs) compared with a sutured repair. METHODS: This prospective, double blinded (patients and outcome assessors), single-center RCT enrolled patients ≥18 years with a small/medium (≤2.5cm) full thickness supraspinatus tear and intact rotator cable. Patients were randomized and blinded to arthroscopic transosseous-equivalent repair (control, n = 30) or IBR (n = 30). The primary outcome was tendon quality on biopsy at 6 months. Secondary outcomes were PROs (American Shoulder and Elbow Surgeons [ASES], Constant-Murley Shoulder [CMS], and pain visual analogue scale scores) and tendon thickness and healing measured via MRI at 6, 12, and 24 months; satisfaction at 12 and 24 months; and time to return to work. RESULTS: Baseline demographic, tear, and surgical characteristics were comparable between the groups (IBR: mean age, 54.2 years, 14 male; control: mean age, 56.4 years, 16 male). Measured via 6 month biopsy, highly organized, parallel bundles of collagen, without inflammation, were present in all IBR patients, whereas poorly organized, non-parallel collagen fibers were present in 24/30 (80%) of control patients (P < .0001), with 28/30 having minimal to mild inflammation. The increase in tendon thickness measured via MRI at 6 months from baseline was greater in the IBR group (2.0 mm) than in the control group (0.8 mm) (P < .0001). All IBR patients had 100% healing on MRI at 12 and 24 months. Compared with the control group, the IBR group had higher ASES and CMS scores at each evaluation, less pain at 6 and 12 months, and greater satisfaction at 12 and 24 months (P < .0003). The IBR group returned to work significantly faster (median 90 days [IQR, 25] vs. median 163.5 days [IQR, 24]; P < .0001) than the control group. CONCLUSION: Compared with a sutured repair, the IBR treatment resulted in superior tendon quality, patient outcomes, satisfaction, and return to work. The IBR enabled a robust healing response evident through MRI and biopsy evaluation, demonstrating superior tendon quality and healing.
ABSTRACT
PURPOSE: To evaluate the clinical outcomes, MRI imaging and histological characteristics of biopsy samples of the tendon from patients in whom rotator cuff repair was previously performed with a bioinductive type I bovine collagen implants. METHODS: Prospective study of 30 patients with partial or complete rotator cuff tears who underwent arthroscopic repair and augmentation with a resorbable type I bovine collagen implant. Preoperatively and at 6 and 12 months after surgery, the VAS, ASES and Constant-Murley scores were evaluated and an MRI study was performed. At 6 months, biopsies of the resulting tissue were obtained and examined histologically. RESULTS: Patients experienced statistically significant and sustained improvement from baseline for all scores and the mean tendon thickness increased by 1.84 mm. Magnetic resonance imaging evidence of complete healing was found in 27 patients and a considerable reduction in defect size, greater than 50%, was shown in 3. In all samples obtained, the new tissue generated had the histological appearance of a tendon, and was indistinguishable from the native tendon. There was no evidence of any remaining collagen implant. CONCLUSIONS: Biopsies of tissue formed from bioinductive type I bovine collagen implants showed, six months after surgery, the generation of a neotendon indistinguishable from the native one. Histology and MRI imaging, revealed complete integration of the implant and absence of inflammatory or foreign body reactions. The clinical parameters, thickness and MRI signal of the tendon improved significantly at 6 months, regardless of the type and size of the tear, and remained unchanged until 12 months. LEVEL OF EVIDENCE: Level IV, case series.
ABSTRACT
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Subject(s)
Female , Humans , Male , Hip Fractures/complications , Hip Fractures/diet therapy , Hip Fractures/surgery , Anemia/complications , Anemia/diet therapy , Anemia/diagnosis , Iron/therapeutic use , Anemia/physiopathology , Erythropoietin/therapeutic use , Receptors, Erythropoietin/therapeutic useABSTRACT
OBJECTIVE: To evaluate if the age, sex and morphology of osteoporotic hip fractures have changed over the last 20 years in our country. MATERIALS AND METHODS: The study included all proximal femoral fractures in patients over 65 years old who were treated at the Miguel Servet Hospital in Zaragoza during the periods 1989-1990 (n = 514 patients), 1999-2000 (n = 518 patients) and 2009-2010 (n = 625 patients). RESULTS: The results showed a statistically significant increase in the mean age of patients with hip fracture from 80.3 years in 1989-1990 period to 82 years in 2009-2010 (p 0.041) and an increase in incidence until 159/100.000 (p <0.001) in 2009-2010 compared with incidence in 1989-1990, that was 98/100.0000. CONCLUSIONS: Hip fractures during the 20 years of this study have been increased by 21,59%. The proportion between the different types of fractures showed no statistically significant change (p> 0.05), despite the increase in the proportion of trochanteric fractures between 1989-2010. There was a statistically significant increase (p <0.001) in the incidence of displaced cervical fractures and a decrease in nondisplaced cervical fractures.
Subject(s)
Hip Fractures/epidemiology , Osteoporosis/complications , Aged , Aged, 80 and over , Female , Hip Fractures/etiology , Humans , Incidence , Male , Retrospective Studies , Spain/epidemiologyABSTRACT
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Subject(s)
Humans , Aged , Male , Hip Fractures/surgery , Blood Transfusion/adverse effects , Cross Infection/etiology , Venous Thrombosis/etiology , Hip Fractures/complications , Postoperative Complications/etiology , Health of the ElderlyABSTRACT
BACKGROUND AND OBJECTIVE: To know the frequency of nosocomial infection (NI) in surgical hip fracture patients and to analyze the risk factors that favor the NI development, especially its relationship with allogeneic blood transfusion (ABT) and intravenous iron administration. PATIENTS AND METHOD: Unicenter prospective observational study of all hip fracture surgery patients during 8 months. The demographic, clinical and hematimetric differences between the infected and not infected patients were described. A logistic regression analysis was made to know the variables that predicted NI development. RESULTS: 26.1% of all 286 patients studied developed NI, urinary infection being the most frequent. The existence of lower hemoglobin or ferritin levels at admission, as well as increased values in ASA (American Society of Anesthesiologists) scale were associated with a greater risk of NI development. ABT and the number of red blood cell units transfused were also associated with an increase of the NI risk. No relationship between intravenous iron administration and NI was found. CONCLUSIONS: Lower haemoglobin and ferritin levels and ABT are associated with an increasing NI risk in surgical hip fracture patients. Thus, in order to decrease the frequency of NI in surgical patients, the development of blood saving protocols including intravenous iron administration would be recommendable.
Subject(s)
Blood Transfusion , Cross Infection/epidemiology , Hip Fractures/surgery , Iron Deficiencies , Iron/administration & dosage , Postoperative Complications/epidemiology , Aged , Aged, 80 and over , Erythrocyte Transfusion , Female , Ferritins/blood , Hemoglobins/analysis , Humans , Logistic Models , Male , Prospective Studies , Risk Factors , Urinary Tract Infections/epidemiologyABSTRACT
FUNDAMENTO Y OBJETIVO: El propósito del estudio ha sido conocer la frecuencia de infección nosocomial(IN) en pacientes intervenidos de fractura de cadera y analizar los factores de riesgoque favorecen el desarrollo de esta infección, especialmente el papel de la transfusión de sangrealogénica (TSA) y de la administración de hierro intravenosa.PACIENTES Y MÉTODO: Se trata de un estudio observacional y prospectivo, en el que se ha incluidoa los pacientes intervenidos de fractura de cadera durante 8 meses. Se describieron las diferenciasdemográficas, clínicas y hematimétricas entre los pacientes con IN y los no infectados,y se realizó un análisis de regresión logística para conocer las variables que pudieron influir enel desarrollo de IN.RESULTADOS: Se ha estudiado a 286 pacientes, de los que el 26,1% desarrolló IN, siendo lainfección urinaria la más frecuente. Los valores descendidos de hemoglobina o ferritina al ingresar,así como los valores elevados de riesgo según la escala de la American Society of Anesthesiologists(ASA), se asociaron a un mayor riesgo de desarrollo de IN. El número de concentradosde hematíes transfundidos también se asoció a un aumento del riesgo de infección. Nose encontró relación entre la administración de hierro intravenosa y la IN.CONCLUSIONES: La hemoglobinemia, la ferropenia y la TSA son factores asociados a riesgo de INen pacientes con fracturas de cadera. Con el objeto de reducir la frecuencia de IN en éstos confractura de cadera, podría ser recomendable el desarrollo de protocolos de ahorro de sangreque incluyeran la administración de hierro intravenosa
BACKGROUND AND OBJECTIVE: To know the frequency of nosocomial infection (NI) in surgical hipfracture patients and to analyze the risk factors that favor the NI development, especially its relationshipwith allogeneic blood transfusion (ABT) and intravenous iron administration.Patients and method: Unicenter prospective observational study of all hip fracture surgery patientsduring 8 months. The demographic, clinical and hematimetric differences between theinfected and not infected patients were described. A logistic regression analysis was made toknow the variables that predicted NI development.RESULTS: 26.1% of all 286 patients studied developed NI, urinary infection being the most frequent.The existence of lower hemoglobin or ferritin levels at admission, as well as increasedvalues in ASA (American Society of Anesthesiologists) scale were associated with a greater riskof NI development. ABT and the number of red blood cell units transfused were also associatedwith an increase of the NI risk. No relationship between intravenous iron administration and NIwas found.CONCLUSIONS: Lower haemoglobin and ferritin levels and ABT are associated with an increasingNI risk in surgical hip fracture patients. Thus, in order to decrease the frequency of NI in surgicalpatients, the development of blood saving protocols including intravenous iron administrationwould be recommendable
Subject(s)
Humans , Hip Fractures/surgery , Cross Infection/epidemiology , Fracture Fixation, Internal/methods , Blood Transfusion , Blood Loss, Surgical , Anemia, Iron-Deficiency/complications , Prospective StudiesABSTRACT
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Humans , Blood Transfusion/economics , Blood Banks/economics , Blood Donors/statistics & numerical data , Health Care Costs/statistics & numerical dataABSTRACT
BACKGROUND AND OBJECTIVE: To assess the cost-effectiveness and the budget impact of a Blood Saving Program (BSP) in patients older than 65 undergoing perthrocanteric hip fracture surgery. PATIENTS AND METHOD: Two groups of patients with perthrocanteric fracture were included. Group 1: patients not receiving treatment for perisurgical anaemia or treated with oral iron; Group 2: patients included in a BSP (treatment with endovenous iron sucrose and alfa epoetin, plus restrictive transfusional criteria). Effectiveness issues were: transfusion rate and number of red blood cell units transfused, length of postoperative stay and infection rate. Treatment cost was calculated using drug and transfused red blood cell unit prizes in 2003. We calculated potential patient population according to 2003 data. RESULTS: 144 patients were included, 43 of which were in the BSP. Both groups were comparable in gender, age, preoperative length of stay, ASA and haemoglobin level at admission. Patients included in the BSP were less transfused and had less infections but postoperative stay was similar in both groups. The budget impact was 239,148 euros 95% [confidence interval (CI) 202,312-311,980] at group 1 and 311,980 euros [95% CI 275,288-348,672] at the BSP group. Including the whole potential population in the BSP (during one year 400 patients) would mean a cost increase of 72,832 euros, avoiding transfusion in 92 patients, infection in 70 patients, and saving 328 red blood cell units. CONCLUSIONS: The cost increase due to endovenous iron sucrose and alfa-epoetin can be considered affordable for the hospital budget. BSP provides lower transfusion and infection rates and saves red blood cell units, compared to the standard procedure. Differences in postoperative stay should be analyzed in further larger and prospective studies including more patients.
Subject(s)
Anemia/economics , Anemia/therapy , Erythrocyte Transfusion/economics , Hip Fractures/economics , Hip Fractures/surgery , Administration, Oral , Age Factors , Aged, 80 and over , Anemia/drug therapy , Anemia/etiology , Budgets , Confidence Intervals , Cost-Benefit Analysis , Costs and Cost Analysis , Data Interpretation, Statistical , Epoetin Alfa , Erythropoietin/administration & dosage , Erythropoietin/therapeutic use , Female , Ferric Compounds/administration & dosage , Ferric Compounds/therapeutic use , Ferric Oxide, Saccharated , Glucaric Acid , Hematinics/administration & dosage , Hematinics/therapeutic use , Humans , Iron/administration & dosage , Iron/therapeutic use , Length of Stay , Male , Recombinant ProteinsABSTRACT
Fundamento y objetivo: El objetivo de este trabajo es estudiar la relación coste-efectividad y el impacto presupuestario que supone para un hospital el establecimiento de un programa de ahorro de sangre alogénica en pacientes ancianos intervenidos quirúrgicamente de fractura de cadera pertrocantérea. Pacientes y método: Se incluyó 2 grupos de pacientes. Grupo 1: pacientes sin tratamiento farmacológico de la anemia perioperatoria o que recibieron hierro oral; y Grupo 2: pacientes incluidos en un programa de ahorro de sangre con criterios transfusionales restrictivos y tratamiento con hierro sacarato intravenoso y epoetina alfa. Se definieron como parámetros de efectividad el porcentaje de transfusiones y el número de concentrados de hematíes transfundidos, la duración de la estancia postoperatoria y el porcentaje de infección hospitalaria. Los costes de tratamiento se calcularon usando el precio de venta a farmacia (PVF) de los fármacos y los costes de unidades de sangre transfundidas y cruzadas en el año 2003 según tarifas oficiales. Se utilizó el año 2003 para establecer la población prevalente. Resultados: Se incluyó a 144 pacientes estudiados de marzo a septiembre de 2003 (101 en el grupo 1 y 43 en el grupo 2). Ambos grupos fueron comparables en sexo, edad, tiempo prequirúrgico, riesgo quirúrgico (ASA) y valores de hemoglobina al ingreso. Los pacientes incluidos en el programa de ahorro de sangre recibieron menos transfusiones y presentaron menos infecciones, aunque la estancia posquirúrgica fue similar en ambos grupos. El impacto presupuestario fue 239.148 euros (intervalo de confianza [IC] del 95%, 202.312-311.980 euros) en el grupo 1 y 311.980 euros (IC del 95%, 275.288-348.672 euros) en el programa de ahorro de sangre. La generalización del ahorro de sangre a toda la población prevalente en 2003 (400 pacientes) supondría un aumento medio de costes para el hospital de 72.832 euros, se evitaría transfusiones a 92 pacientes y se ahorraría 328 concentrados de hematíes y 70 infecciones hospitalarias. Conclusiones: El aumento en el gasto que implica la generalización del uso del hierro sacarato intravenoso y la epoetina alfa no se considera especialmente gravoso para el presupuesto del hospital. Este incremento en el coste evita transfusiones sanguíneas, bolsas de sangre e infecciones hospitalarias, pero no queda del todo claro en qué supuestos disminuye la estancia media, punto que se debería analizar con estudios prospectivos o de mayor tamaño muestral
Background and objetive: To assess the cost-effectiveness and the budget impact of a Blood Saving Program (BSP) in patients older than 65 undergoing perthrocanteric hip fracture surgery. Patients and method: Two groups of patients with perthrocanteric fracture were included. Group 1: patients not receiving treatment for perisurgical anaemia or treated with oral iron; Group 2: patients included in a BSP (treatment with endovenous iron sucrose and alfa epoetin, plus restrictive transfusional criteria). Effectiveness issues were: transfusion rate and number of red blood cell units transfused, length of postoperative stay and infection rate. Treatment cost was calculated using drug and transfused red blood cell unit prizes in 2003. We calculated potential patient population according to 2003 data. Results: 144 patients were included, 43 of which were in the BSP. Both groups were comparable in gender, age, preoperative length of stay, ASA and haemoglobin level at admission. Patients included in the BSP were less transfused and had less infections but postoperative stay was similar in both groups. The budget impact was 239,148 euros 95% [confidence interval (CI) 202,312-311,980] at group 1 and 311,980 euros [95% CI 275,288-348,672] at the BSP group. Including the whole potential population in the BSP (during one year 400 patients) would mean a cost increase of 72,832 euros, avoiding transfusion in 92 patients, infection in 70 patients, and saving 328 red blood cell units. Conclusions: The cost increase due to endovenous iron sucrose and alfa-epoetin can be considered affordable for the hospital budget. BSP provides lower transfusion and infection rates and saves red blood cell units, compared to the standard procedure. Differences in postoperative stay should be analyzed in further larger and prospective studies including more patients
Subject(s)
Male , Female , Aged , Humans , Blood Transfusion/economics , Hip Fractures/surgery , Fracture Fixation/economics , Epoetin Alfa/administration & dosage , Iron/administration & dosage , Cost Efficiency Analysis , Cost Savings/methods , Clinical Protocols , Economics, Hospital/trendsABSTRACT
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Subject(s)
Male , Female , Aged , Humans , Blood Loss, Surgical/prevention & control , Hemostasis, Surgical/methods , Preoperative Care/methods , Iron/administration & dosage , Hip Fractures/surgeryABSTRACT
BACKGROUND AND OBJECTIVE: An important percentage of patients with hip fracture need allogeneic transfusion to resolve their perioperative anemia. Our goal was to determine the safety profile and usefulness of parenteral iron in order to avoid allogeneic transfusions in trochanteric hip fracture (THF). PATIENTS AND METHOD: A pseudo-experimental study was performed comparing a historic THF group (n = 104) with another group (n = 23) treated with parenteral iron (Venofer) (doses of 100 mg). Patients who had primary blood diseases or were receiving anticoagulation therapy were excluded. Age, gender, elapsed time, type of THF (international AO classification), surgical procedure, transfusion procedure and quantity, hemoglobin and hematocrit at days 0 and +2 (if a surgical procedure was not performed) and postoperatively were examined. We also analyzed the morbidity (post-surgical infection) and hospital stay and mortality rate at the first month. RESULTS: We have not observed any adverse reactions upon iron administration. The iron group was transfused less times (39.1% vs. 56.7%) and had lower morbidity (infection) (20.3% vs. 35.4%) (p = 0.04), lower mortality (13% vs. 16.3%), less blood consumption (0.87 vs. 1.31 units) and less stay (13.7 vs. 14.3 days). CONCLUSIONS: Parenteral administration of iron could be a safe and effective way to avoid or reduce allogeneic blood transfusions in THF patients. The reduction in the transfusional rate in the iron treated group is also accompanied by a reduction in the morbidity, infection rate, mortality rate and hospital stay.
Subject(s)
Anemia/prevention & control , Blood Loss, Surgical , Ferric Compounds/administration & dosage , Hematinics/administration & dosage , Hip Fractures/surgery , Iron/administration & dosage , Sucrose/administration & dosage , Aged , Aged, 80 and over , Anemia/etiology , Blood Transfusion , Female , Ferric Oxide, Saccharated , Glucaric Acid , Humans , Infusions, Intravenous , MaleABSTRACT
The authors report a case of an irreducible dorsal dislocation of the first metatarsophalangeal joint, with concomitant Lisfranc dislocation and fractures of the second, third, and fourth metatarsals. This combination has been reported only once in the literature. This extremely rare combined injury results in a floating metatarsal. Open reduction of the metatarsophalangeal joint dislocation and fixation of Lisfranc joint and metatarsal fractures with Kirschner wires was performed. One year after surgery, the patient is active and the first metatarsophalangeal joint is asymptomatic, but there is mild pain in the Lisfranc joint.
