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PURPOSE: To evaluate the safety and efficacy of matrix-associated autologous chondrocyte implantation (ACI) using spheroids in comparison to arthroscopic microfracture for the treatment of symptomatic cartilage defects of the knee. METHODS: In a prospective multicenter-controlled trial, patients aged between 18 and 50 years, with single symptomatic focal cartilage defects between 1 and 4 cm2 (mean 2.6 ± 0.8, median 2.75, range 1.44-5.00) in the knee were randomized to treatment with ACI with spheroids (n = 52) or microfracture (n = 50). Primary clinical outcome was assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS). Analyses were performed in a defined hierarchical manner where outcomes of ACI were first compared to baseline values followed by a comparison to the microfracture group with repeated-measures ANCOVA with a non-inferiority approach. Subgroup analyses were performed to investigate the influence of age and defect size on the overall KOOS. Secondary clinical outcomes were the magnetic resonance observation of cartilage repair tissue (MOCART), modified Lysholm score and International Knee Documentation Committee (IKDC) examination form. Safety data focused on adverse events. Here the 5 years results are presented at which there were 33 observed cases in the ACI group and 30 in the microfracture group. RESULTS: The overall KOOS and its five subscores were significantly improved compared to baseline for both the ACI and microfracture group. Non-inferiority of ACI to microfracture was confirmed for the overall KOOS and the subscores, while for the subscores activities of daily living, quality of life and sports and recreation of the threshold for superiority was passed. In the ACI group, a notably more rapid initial improvement of the KOOS was found at three months for the older age group compared to the younger age group and the microfracture group. No other differences were found based on age or defect size. In addition, clinical improvement was found for the MOCART, modified Lysholm and IKDC examination form both the ACI and microfracture group. No safety concern related to either treatment was observed. CONCLUSION: This study confirms the safety and efficacy of matrix-associated ACI with spheroids at a mid to long-term follow-up. Non-inferiority of ACI to microfracture was confirmed for the overall KOOS and all subscores, while superiority was reached for the subscores activities of daily living, quality of life and sports and recreation in the ACI group. This underlines the importance of ACI for the young and active patients. LEVEL OF EVIDENCE: I.
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Enfermedades de los Cartílagos , Cartílago Articular , Fracturas por Estrés , Humanos , Anciano , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Condrocitos/trasplante , Cartílago Articular/lesiones , Actividades Cotidianas , Fracturas por Estrés/cirugía , Fracturas por Estrés/patología , Estudios Prospectivos , Calidad de Vida , Trasplante Autólogo/métodos , Enfermedades de los Cartílagos/cirugía , Articulación de la Rodilla/cirugía , Imagen por Resonancia Magnética/métodosRESUMEN
Loose bodies (LBs) from patients with osteochondritis dissecans (OCD) are usually removed and discarded during surgical treatment of the defect. In this study, we address the question of whether these LBs contain sufficient viable and functional chondrocytes that could serve as a source for autologous chondrocyte implantation (ACI) and how the required prolonged in vitro expansion affects their phenotype. Chondrocytes were isolated from LBs of 18 patients and compared with control chondrocyte from non-weight-bearing joint regions (n = 7) and bone marrow mesenchymal stromal cells (BMSCs, n = 6) obtained during primary arthroplasty. No significant differences in the initial cell yield per isolation and the expression of the chondrocyte progenitor cell markers CD44 + /CD146+ were found between chondrocyte populations from LBs (LB-CH) and control patients (Ctrl-CH). During long-term expansion, LB-CH exhibited comparable viability and proliferation rates to control cells and no ultimate cell cycle arrest was observed within 12 passages respectively 15.3 ± 1.1 mean cumulative populations doublings (CPD). The chondrogenic differentiation potential was comparable between LB-CH and Ctrl-CH, but both groups showed a significantly higher ability to form a hyaline cartilage matrix in vitro than BMSC. Our data suggest that LBs are a promising cell source for obtaining qualitatively and quantitatively suitable chondrocytes for therapeutic applications, thereby circumventing donor site morbidity as a consequence of the biopsies required for the current ACI procedure.
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Cartílago Articular , Condrocitos , Procedimientos Ortopédicos , Cartílago , Cartílago Articular/patología , Diferenciación Celular , Condrocitos/metabolismo , Condrocitos/trasplante , Células Madre Mesenquimatosas/metabolismo , Procedimientos Ortopédicos/métodos , Trasplante Autólogo/métodosRESUMEN
INTRODUCTION: Cartilage defects in the knee can be caused by injury, various types of arthritis, or degeneration. As a long-term consequence of cartilage defects, osteoarthritis can develop over time, often leading to the need for a total knee replacement (TKR). The treatment alternatives of chondral defects include, among others, microfracture, and matrix-associated autologous chondrocyte implantation (M-ACI). The purpose of this study was to determine cost-effectiveness of M-ACI in Germany with available mid- and long-term outcome data, with special focus on the avoidance of TKR. MATERIALS AND METHODS: We developed a discrete-event simulation (DES) that follows up individuals with cartilage defects of the knee over their lifetimes. The DES was conducted with a status-quo scenario in which M-ACI is available and a comparison scenario with no M-ACI available. The model included 10,000 patients with articular cartilage defects. We assumed Weibull distributions for short- and long-term effects for implant failures. Model outcomes were costs, number of TKRs, and quality-adjusted life years (QALYs). All analyses were performed from the perspective of the German statutory health insurance. RESULTS: The majority of patients was under 45 years old, with defect sizes between 2 and 7 cm2 (mean: 4.5 cm2); average modeled lifetime was 48 years. In the scenario without M-ACI, 26.4% of patients required a TKR over their lifetime. In the M-ACI scenario, this was the case in only 5.5% of cases. Thus, in the modeled cohort of 10,000 patients, 2700 TKRs, including revisions, could be avoided. Patients treated with M-ACI experienced improved quality of life (22.53 vs. 21.21 QALYs) at higher treatment-related costs (18,589 vs. 14,134 /patient) compared to those treated without M-ACI, yielding an incremental cost-effectiveness ratio (ICER) of 3376 /QALY. CONCLUSION: M-ACI is projected to be a highly cost-effective treatment for chondral defects of the knee in the German healthcare setting.
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Enfermedades de los Cartílagos , Cartílago Articular , Humanos , Persona de Mediana Edad , Condrocitos , Análisis Costo-Beneficio , Calidad de Vida , Trasplante Autólogo , Cartílago Articular/lesiones , Articulación de la Rodilla , Costos de la Atención en SaludRESUMEN
INTRODUCTION: Osteochondral defects of the knee may cause functional impairment of young and sportively active patients. Different surgical treatment options have been proposed using either one or two step procedures. The aim of the current study was to evaluate mid-term outcomes of combined bone grafting with autologous matrix-associated chondrogenesis (AMIC) for the treatment of large osteochondral defects. MATERIALS AND METHODS: 15 Patients with osteochondrosis dissecans of the medial femoral condyle grade III or IV according to ICRS classification were treated with a single step surgical procedure combining bone grafting and the AMIC procedure. Mean defect size was 4.98 cm2 (± 3.02) and patients were examined at 6, 12 weeks, 6 and 12 month and at mean final follow-up of 49 months (36-61). Patients were evaluated using VAS, IKDC, KOOS, Lysholm, Tegner activity scores and psychological and physical health assessed using the SF 12. MRI evaluation was performed at final follow-up using the MOCART score. RESULTS: Pain had significantly decreased at final follow-up (7.2 ± 1.4 vs. 2.4 ± 2.6) compared to preoperative baseline. All functional scores had improved significantly throughout the follow-up period (IKDC from 36.6 ± 20.6 vs. 72.2 ± 18.7; KOOS 50.0 ± 18.9 vs. 81.7 ± 13.9; LYSHOLM 39.3 ± 19.5 vs. 79.8 ± 15.1). SF12 evaluation showed a significant increase in physical component summary (PCS) (31.2 ± 11.1 preoperative vs. 46.3 ± 9.9 at final follow-up), while mental component summary (MCS) remained stable (51.8 ± 8.9 vs. 57.3 ± 3.3). MOCART score revealed a mean overall score of 77 ± 15 at final follow-up. Integration to the adjacent cartilage was complete in 79%, incomplete in 21%. Defect filling was complete in 64%, incomplete in 36%. CONCLUSION: Significant improvement of knee function and restoration of homogenous cartilage morphology could be achieved with simultaneous AMIC procedure and bone grafting in 2/3 of all patients with large osteochondral lesions at 4 years postoperatively.
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Trasplante Óseo/métodos , Condrogénesis/fisiología , Articulación de la Rodilla/cirugía , Osteocondritis Disecante/cirugía , Trasplante Autólogo/métodos , Artralgia , Humanos , Complicaciones Posoperatorias , Resultado del TratamientoRESUMEN
PURPOSE: Clinical reports on meniscal scaffolds seem promising, albeit relatively paucity exists regarding their biomechanical behavior. The aim of the study is to delineate the impact of differing suture materials and the type as well as the temperature of the irrigation fluid on the pull-out strength of a polyurethane meniscal scaffold (Actifit®). MATERIALS AND METHODS: 128 specimens were utilized with horizontal sutures and uniaxial load-to-failure testing was performed. We compared two different suture materials-polydioxanone (PDS) and non-absorbable, braided polyester sutures (NABP)-as well as two common irrigation fluids-lactated Ringer's and electrolyte-free, hypotonic Mannitol-Sorbitol. All specimens were further evaluated according to two different temperatures [room temperature (20 °C) and near-core body temperature (37 °C)]. RESULTS: Mean load-to-failure was 53.3 ± 6.5 N. There was no significant difference between the NABP and the PDS group. Ringer group showed a significantly higher load-to-failure compared to Purisole (P = .0002). This was equivalent for both PDS (P = .0008) and NABP sutures (P = .0008). Significantly higher failure loads could be established for the 37° group (P = .041); yet, this difference was neither confirmed for the PDS or in in the NABP subgroup. Only the subgroup using Purisole at 37° showed significantly higher failure loads compared to 20° (P = .017). CONCLUSIONS: This study underlines the potential to improve pull-out strength during implantation of an Actifit® scaffold by alteration of the type of irrigation fluid. Lactated Ringer solution provided the highest construct stability in regard to load-to-failure testing and should be considered whenever implantation of a polyurethane meniscal scaffold is conducted.
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Materiales Biocompatibles/química , Polidioxanona/química , Poliésteres/química , Suturas , Fenómenos Biomecánicos , Soluciones Isotónicas/química , Ensayo de Materiales , Lactato de Ringer , Resistencia a la TracciónRESUMEN
PURPOSE: The pivot shift test is performed in different techniques and the rotation of the tibia seems to have a significant impact on the amount of the pivot shift phenomenon. It has been hypothesised that external rotation will increase the phenomenon due to less tension at the iliotibial band in knee extension. METHODS: Twenty-four patients with unilateral anterior cruciate ligament insufficiency were included prospectively. The pivot shift test was performed bilaterally in internal and external tibial rotation under general anaesthesia. Knee motion was captured using a femoral and a tibial inertial sensor. The difference between positive and negative peak values in Euclidean norm of acceleration was calculated to evaluate the amount of the pivot shift phenomenon. RESULTS: The pivot shift phenomenon was significantly increased in patients with ACL insufficiency when the test was performed in external [mean 5.2 ms- 2 (95% CI 4.3-6.0)] compared to internal tibial rotation [mean 4.4 ms- 2 (95% CI 3.5-5.4)] (p = 0.002). In healthy, contralateral knees did not show any difference between external [mean 4.0 ms- 2 (95% CI 3.3-4.7)] and internal tibial rotation [mean 4.0 ms- 2 (95% CI 3.4-4.6)] (ns). CONCLUSIONS: The pivot shift phenomenon was increased with external rotation in ACL-insufficient knees, and therefore, one should perform the pivot shift test, rather, in external rotation to easily evoke the, sometimes difficult to detect, pivot shift phenomenon. LEVEL OF EVIDENCE: I (diagnostic study).
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Lesiones del Ligamento Cruzado Anterior/fisiopatología , Inestabilidad de la Articulación/fisiopatología , Articulación de la Rodilla/fisiopatología , Examen Físico/métodos , Rotación , Adulto , Fenómenos Biomecánicos/fisiología , Humanos , Estudios Prospectivos , Rango del Movimiento Articular/fisiologíaRESUMEN
The Working Group of the German Orthopedic and Trauma Society (DGOU) on Tissue Regeneration has published recommendations on the indication of different surgical approaches for treatment of full-thickness cartilage defects in the knee joint in 2004, 2013 and 2016. Based upon new scientific knowledge and new developments, this recommendation is an update based upon the best clinical evidence available. In addition to prospective randomised controlled clinical trials, this also includes studies with a lower level of evidence. In the absence of evidence, the decision is based on a consensus process within the members of the working group.The principle of making decision dependent on defect size has not been changed in the new recommendation either. The indication for arthroscopic microfracturing has been reduced up to a defect size of 2 cm2 maximum, while autologous chondrocyte implantation is the method of choice for larger cartilage defects. Additionally, matrix-augmented bone marrow stimulation (mBMS) has been included in the recommendation for defects ranging from 1 to 4.5 cm2. For the treatment of smaller osteochondral defects, in addition to osteochondral transplantation (OCT), mBMS is also recommended. For larger defects, matrix-augmented autologous chondrocyte implantation (mACI/mACT) in combination with augmentation of the subchondral bone is recommended.
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Enfermedades de los Cartílagos , Cartílago Articular , Procedimientos Ortopédicos , Ortopedia , Humanos , Estudios Prospectivos , Enfermedades de los Cartílagos/cirugía , Articulación de la Rodilla/cirugía , Condrocitos , Cartílago Articular/cirugía , Cartílago Articular/lesionesRESUMEN
OBJECTIVES: Assessment of cartilage lesions and osteoarthritis (OA) of the patellofemoral joint in patients following lateral patellar dislocation using magnetic resonance imaging (MRI). METHODS: MR images of 129 knees (mean age 26 years, range 11-56) grouped as acute (A), recurrent (B), and chronic (C) dislocators were analysed regarding the prevalence and severity of patellofemoral cartilage lesions. Grades of OA were assessed using modified WORMS. RESULTS: In groups A, B, and C the prevalence of cartilage lesions was 71%, 82%, and 97%, respectively. Most lesions were located on the central patella in groups A and B (central 69% and 78%; medial 56% and 47%; lateral 31% and 42%), whereas group C revealed all regions affected (73%, 61%, and 67%). Of group A, 14% had mild OA and 64% of group B. Group C showed mild OA in 62% and moderate OA in 18%. Cartilage defect size and prevalence of OA was correlated with number of dislocations (r = 0.41 and r = 0.59; P < 0.001). CONCLUSIONS: Cartilage lesions and early OA are common after patellar dislocation and appear to increase with the frequency of dislocation. Both conditions should be considered when interpreting MRI in such patients, because of implications for treatment. KEY POINTS : ⢠Cartilage lesions are very common after patellar dislocation. ⢠The severity of cartilage lesions increases with number of dislocations. ⢠Osteoarthritis is common after recurrent patellar dislocation, even in young patients. ⢠Detecting cartilage lesions is important after patellar dislocation.
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Cartílago/patología , Imagen por Resonancia Magnética/métodos , Osteoartritis/patología , Luxación de la Rótula/epidemiología , Luxación de la Rótula/patología , Adolescente , Adulto , Niño , Diagnóstico por Imagen/métodos , Humanos , Persona de Mediana Edad , Variaciones Dependientes del Observador , Prevalencia , Reproducibilidad de los ResultadosRESUMEN
Although allografts for anterior cruciate ligament (ACL) replacement have shown advantages compared to autografts, their use is limited due to the risk of disease transmission and the limitations of available sterilization methods. Gamma sterilization has shown detrimental effects on graft properties at the high doses required for sufficient pathogen inactivation. In our previous in vitro study on human patellar tendon allografts, Electron beam (Ebeam) irradiation showed less detrimental effects compared to gamma sterilization (Hoburg et al. in Am J Sports Med 38(6):1134-1140, 2010). To investigate the biological healing and restoration of the mechanical properties of a 34 kGy Ebeam treated tendon allograft twenty-four sheep underwent ACL replacement with either a 34 kGy Ebeam treated allograft or a non-sterilized fresh frozen allograft. Biomechanical testing of stiffness, ultimate failure load and AP-laxity as well as histological analysis to investigate cell, vessel and myofibroblast-density were performed after 6 and 12 weeks. Native sheep ACL and hamstring tendons (HAT, each n = 9) served as controls. The results of a previous study analyzing the remodeling of fresh frozen allografts (n = 12) and autografts (Auto, n = 18) with the same study design were also included in the analysis. Statistics were performed using Mann-Whitney U test followed by Bonferroni-Holm correction. Results showed significantly decreased biomechanical properties during the early remodeling period in Ebeam treated grafts and this was accompanied with an increased remodeling activity. There was no recovery of biomechanical function from 6 to 12 weeks in this group in contrast to the results observed in fresh frozen allografts and autografts. Therefore, high dose Ebeam irradiation investigated in this paper cannot be recommended for soft tissue allograft sterilization.
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Reconstrucción del Ligamento Cruzado Anterior , Ligamento Cruzado Anterior , Ligamento Rotuliano/efectos de la radiación , Radiación Ionizante , Esterilización/métodos , Animales , Ligamento Cruzado Anterior/efectos de la radiación , Ligamento Cruzado Anterior/cirugía , Ligamento Cruzado Anterior/trasplante , Fenómenos Biomecánicos , Plastía con Hueso-Tendón Rotuliano-Hueso , Electrones , Femenino , Ligamento Rotuliano/cirugía , Ligamento Rotuliano/trasplante , Ovinos , Trasplante AutólogoRESUMEN
BACKGROUND: For increasing allograft tendon safety in reconstructive surgery, an effective sterilization method achieving sterility assurance including viruses without impairing the grafts properties is needed. Fractionated Electron Beam (Ebeam) has shown promising in vitro results. The proof of sufficient virus inactivation is a central part of the process validation. METHODS: The Ebeam irradiation of the investigated viruses was performed in an optimized manner (oxygen content < 0.1%, -78 °C). Using principles of a tendon model the virus inactivation kinetics for HIV-2, HAV, pseudorabies virus (PRV) and porcine parvovirus (PPV) were calculated as TCID(50)/ml and D(10) value (kGy) for the fractionated (10 × 3.4 kGy) and the standard (1 × 34 kGy) Ebeam irradiation. RESULTS: All viruses showed comparable D(10) values for both Ebeam treatments. For sufficient virus titer reduction of 4 log(10) TCID(50)/ml, a dose of 34 kGy of the fractionated Ebeam irradiation was necessary in case of HIV-2, which was the most resistant virus investigated in this study. CONCLUSION: The fractionated and the standard Ebeam irradiation procedure revealed comparable and sufficient virus inactivation capacities. In combination with the known good biomechanical properties of fractionated Ebeam irradiated tendons, this method could be a safe and effective option for the terminal sterilization of soft tissue allografts.
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BACKGROUND: Matrix-associated autologous chondrocyte implantation (ACI) is a well-established treatment for cartilage defects. High-level evidence at midterm follow-up is limited, especially for ACI using spheroids (spherical aggregates of ex vivo expanded human autologous chondrocytes and self-synthesized extracellular matrix). PURPOSE: To assess the safety and efficacy of 3-dimensional matrix-associated ACI using spheroids to treat medium to large cartilage defects on different locations in the knee joint (patella, trochlea, and femoral condyle) at 5-year follow-up. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: A total of 75 patients aged 18 to 50 years with medium to large (4-10 cm2), isolated, single cartilage defects, International Cartilage Repair Society grade 3 or 4, were randomized on a single-blind basis to treatment with ACI at 1 of 3 dose levels: 3 to 7, 10 to 30, or 40 to 70 spheroids/cm2 of defect size. Outcomes were assessed via changes from baseline Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and modified Lysholm assessments at 1- and 5-year follow-up. Structural repair was evaluated using MOCART (magnetic resonance observation of cartilage repair tissue) score. Treatment-related adverse events were assessed up to 5 years for all patients. The overall KOOS at 12 months was assessed for superiority versus baseline in a 1-sample, 2-sided t test. RESULTS: A total of 73 patients were treated: 24 in the low-dose group, 25 in the medium-dose group, and 24 in the high-dose group. The overall KOOS improved from 57.0 ± 15.2 at baseline to 73.4 ± 17.3 at 1-year follow-up (P < .0001) and 76.9 ± 19.3 at 5-year follow-up (P < .0001), independent of the applied dose. The different defect locations (patella, trochlea, and weightbearing part of the femoral condyles; P = .2216) and defect sizes (P = .8706) showed comparable clinical improvement. No differences between the various doses were observed. The overall treatment failure rate until 5 years was 4%. Most treatment-related adverse events occurred within the first 12 months after implantation, with the most frequent adverse reactions being joint effusion (n = 71), arthralgia (n = 14), and joint swelling (n = 9). CONCLUSION: ACI using spheroids was safe and effective for defect sizes up to 10 cm2 and showed maintenance of efficacy up to 5 years for all 3 doses that were investigated. REGISTRATION: NCT01225575 (ClinicalTrials.gov identifier); 2009-016816-20 (EudraCT number).
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OBJECTIVE: Matrix-associated autologous chondrocyte implantation (ACI) and microfracture (MF) are well-established treatments for cartilage defects of the knee. However, high-level evidence comparing microfracture and spheroid technology ACI is limited. DESIGN: Prospective, phase III clinical trial with patients randomized to ACI (N = 52) or MF (N = 50). Level of evidence: 1, randomized controlled trial. Both procedures followed standard protocols. For ACI 10 to 70 spheroids/cm2 were administered. Primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS). This report presents results for 36 months after treatment. RESULTS: Both ACI and MF showed significant improvement over the entire 3-year observation period. For the overall KOOS, noninferiority of ACI (the intended primary goal of the study) was formally confirmed; additionally, for the subscores "Activities of Daily Living" and "Sport and Recreation," superiority of ACI over MF was shown at descriptive level. Occurrence of adverse events were not different between both treatments (ACI 77%; MF 74%). Four patients in the MF group required reoperation which was defined as treatment failure. No treatment failure was reported for the ACI group. CONCLUSIONS: Patients treated with matrix-associated ACI with spheroid technology showed substantial improvement in various clinical outcomes after 36 months. The advantages of ACI compared with microfracture was underlined by demonstrating noninferiority, in overall KOOS and superiority in the KOOS subscores "Activities of Daily Living" and "Sport and Recreation." In the present study, subgroups comparing different age groups and defect sizes showed comparable clinical outcomes.
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Cartílago Articular , Fracturas por Estrés , Actividades Cotidianas , Cartílago Articular/cirugía , Condrocitos , Fracturas por Estrés/cirugía , Humanos , Estudios Prospectivos , Tecnología , Trasplante Autólogo/métodosRESUMEN
The use of cementless threaded cups in THA is a well-established treatment. Fractures of the cups are rare complications recorded in individual cases with material defects being discussed as the primary cause. We analyzed three cases of fractured cups. Although all three cups were well fixed to existing bone, we observed deficient osseous backing dorsocranially and abrasion particles. There were no signs of femoroacetabular impingement or infection. The cups showed corrosion debris. Scanning electron microscopic investigations showed characteristics of fretting and fretting-related corrosion. We concluded the fractures occurred because of fretting combined with inadequate bony support leading to fatigue of the material and subsequent fracture.
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Artritis/cirugía , Artroplastia de Reemplazo de Cadera/instrumentación , Luxación Congénita de la Cadera/cirugía , Articulación de la Cadera/cirugía , Prótesis de Cadera , Falla de Prótesis , Adulto , Artritis/diagnóstico por imagen , Femenino , Luxación Congénita de la Cadera/diagnóstico por imagen , Articulación de la Cadera/diagnóstico por imagen , Humanos , Masculino , Diseño de Prótesis , Radiografía , Reoperación , Estrés Mecánico , Propiedades de SuperficieRESUMEN
BACKGROUND: Symptomatic cartilage defects of the knee are commonly surgically treated by microfracture (MFX) or matrix-associated chondrocyte implantation (M-ACI). Several randomized controlled trials have compared MFX and M-ACI, showing a tendency to lower reoperation rates for M-ACI, but results vary widely between studies. PURPOSE: To compare reoperation rates after MFX and M-ACI in cartilage defects of the knee outside clinical trials in a representative sample of the population. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: This study was based on anonymized, population-representative claims data of 4 million insured persons in Germany. Patients who underwent MFX or M-ACI for cartilage defects of the knee with a follow-up of 2 years were compared. The primary endpoint was the need for a reoperation, defined as a claim for a second surgical procedure from the same patient at the knee joint (27 procedure codes), meniscus and cartilage (35 procedure codes), or patella (102 procedure codes) or the need for knee replacement (11 procedure codes). Group comparisons were performed using log-rank tests, with a 2-sided P value of <.05 to indicate significance. For adjusted analysis, propensity score matching was applied. Age, sex, comedications, and comorbidities were used as matching parameters. RESULTS: A total of 6425 patients fulfilled the inclusion criteria: 6273 treated with MFX and 152 treated with M-ACI (mean age, 53 and 36 years, respectively). In the 2 years after treatment, 1271 patients in the MFX group needed a reoperation compared with 19 in the M-ACI group (20.3% vs 12.5%, respectively; P = .0199). For adjusted analysis after propensity score matching, 127 patients per group were analyzed. Their mean age was 37 years. At the end of the second follow-up year, 28 and 16 patients needed reoperations in the MFX and M-ACI groups, respectively (22.0% vs 12.6%, respectively; P = .0498). CONCLUSION: This study used a representative sample of the population and a broad definition of a reoperation, thus expanding evidence from clinical trials. We found a significant advantage of M-ACI in reoperation rates 2 years after treatment. After adjusting for age, sex, comedications, and comorbidities, M-ACI still showed significantly lower reoperation rates after 2 years.
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BACKGROUND: Articular cartilage damage is caused by traumatic sport accidents or age-related degeneration and might lead to osteoarthritis, which represents a socioeconomic burden to society. Cartilage damage in the knee is commonly treated surgically with microfracture (MFX) or matrix-associated autologous chondrocyte implantation (MACI). PURPOSE: To quantify the initial and follow-up costs associated with MFX and MACI treatments from the viewpoint of statutory health insurance in Germany. STUDY DESIGN: Economic decision analysis; Level of evidence, 2. METHODS: This comparative study was based on an anonymized representative claims data set of 4 million patients covered by statutory health insurance in Germany. Patients undergoing outpatient or inpatient treatment with MACI or MFX for cartilage damage in the knee between January 1, 2012, and December 31, 2013, were included and evaluated over 5 years. Groups (MACI and MFX) were adjusted via propensity score matching before initial treatment. The matched groups were compared regarding their outpatient, inpatient, pharmaceutical, and other costs during the 5-year period. RESULTS: In total, 127 patients per group were analyzed (59.1% male, 40.9% female; mean age, 37 years). In the year of the initial surgical procedure, costs were 14,804.13 in the MACI group and 5458.59 in the MFX group. In years 2 and 3 after initial surgery, treatment costs were comparable between patients treated with MACI (2897.97 and 2114.87, respectively) and MFX (2842.66 and 1967.42, respectively), with slightly higher treatment costs for those treated with MACI. In years 4 and 5 after surgery, costs were less in patients treated with MACI (2154.79 and 1478.08, respectively) than in those treated with MFX (2232.57 and 2061.63, respectively). Costs related to revision surgery were, on average, 3732 for MACI and 3765 for MFX. Thus, additional costs in years with revision surgery were 1672 for MACI and 1915 for MFX. CONCLUSION: This was the first study to analyze a large representative population claims database with propensity score matching, and results indicated that follow-up costs of patients treated with MACI and MFX began to converge over time. We found that total costs for MACI were higher than for MFX but that additional costs for MACI were lower than previously reported. Perceived morbidity may have little to do with cost.
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BACKGROUND: Autologous chondrocyte implantation (ACI) is an established method for treating cartilage defects in the knee of adult patients. However, less is known about its effectiveness in adolescents. HYPOTHESIS: Third-generation matrix-associated ACI (MACI) using spheroids (co.don chondrosphere/Spherox) is an effective and safe treatment for articular cartilage defects in adolescents aged 15 to 17 years, with outcomes comparable with those for young adults aged 18 to 34 years. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: A total of 71 patients (29 adolescents, 42 young adults) who had undergone ACI using spheroids were evaluated retrospectively in this multicenter study. For adolescents, the mean defect size was 4.6 ± 2.4 cm2, and the follow-up range was 3.5 to 8.0 years (mean, 63.3 months). For young adults, the mean defect size was 4.7 ± 1.2 cm2, and the follow-up range was 3.8 to 4.3 years (mean, 48.4 months). At the follow-up assessment, outcomes were assessed by using validated questionnaires (Knee injury and Osteoarthritis Outcome Score [KOOS], International Knee Documentation Committee [IKDC] subjective knee evaluation form and current health assessment form, and modified Lysholm score), the magnetic resonance observation of cartilage repair tissue (MOCART) score, and if relevant, time to treatment failure. Safety was assessed by the treatment failure rate. RESULTS: No significant difference between the 2 study groups was found for KOOS, IKDC, or MOCART scores, with all patients achieving high functional values. A significant difference was found in the modified Lysholm score, favoring the young adult group over the adolescent group (22.3 ± 1.9 vs 21.0 ± 2.4, respectively; P = .0123). There were no differences between the rates of treatment failure, with 3% in the adolescent group and 5% in the young adult group. CONCLUSION: Third-generation MACI using spheroids is a safe and effective treatment for large cartilage defects of the knee in adolescents at midterm follow-up. Outcomes are comparable with those for young adults after ACI.
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BACKGROUND: The role of meniscus scaffolds remains controversial as failure rates remain high. The aim of this study was to evaluate the pullout strength of different suture materials used for fixation of the Collagen Meniscus Implant (CMI) regarding different suture materials, and type or temperature of irrigation fluid. METHODS: One-hundred and twelve specimens were utilized with horizontal sutures and mounted to a dedicated test device. Loads were applied perpendicular to the CMI, until failure. Two differing suture materials - polydioxanone (PDS) and non-absorbable, braided polyester sutures (NABP) - were evaluated. Additionally, two common irrigation fluids - lactated Ringer's and electrolyte-free, hypotonic Mannitol-Sorbitol solution - were evaluated. Specimens were further evaluated according to different temperatures of the irrigation fluid. Half of the constructs were tested at room temperature (20°C) and half were evaluated at near-core body temperature (37°C). RESULTS: PDS sutures showed a significantly higher load-to-failure compared to NABP sutures (P=0.0008). Regarding the type of irrigation fluid, the electrolyte-free Mannitol-Sorbitol solution showed a significantly higher load-to-failure compared to the overall Ringer group (P b 0.0001). This was equivalent for both the PDS (P=0.015) and for the NABP sutures (P b 0.0001). The temperature of the irrigation fluid did not significantly influence load-to-failure. CONCLUSIONS: PDS sutures and electrolyte-free Mannitol-Sorbitol irrigation fluid provided the best biomechanical properties regarding load-to-failure testing. This study underlines the potential to improve construct stability for the CMI by alteration of the suture material and the type of irrigation fluid, which should be considered whenever scaffold fixation is conducted.
Asunto(s)
Ensayo de Materiales/métodos , Meniscos Tibiales/cirugía , Suturas/efectos adversos , Lesiones de Menisco Tibial/cirugía , Andamios del Tejido/efectos adversos , Fenómenos Biomecánicos , Colágeno , Meniscos Tibiales/fisiopatología , Poliésteres , Falla de Prótesis , Técnicas de Sutura , Temperatura , Resistencia a la Tracción/fisiología , Irrigación Terapéutica , Lesiones de Menisco Tibial/fisiopatología , Andamios del Tejido/químicaRESUMEN
BACKGROUND: The posterior cruciate ligament (PCL) avulsion fracture from its tibial insertion is a rare condition. Despite the further technical advent in refixation of avulsion fractures, the reported failure rate of current approaches remains high and the optimal surgical technique has not been elucidated yet. The purpose of the current study is to present an all-inside arthroscopic reconstruction technique for bony tibial avulsion fractures of the PCL and initial clinical outcomes. METHODS: Patients underwent a thorough clinical and radiological examination of both knees at 3, 6, 12, 18, and if possible also at 24 months. Clinical evaluation included subjective and objective IKDC 2000, Lysholm score, and KOOS score. Radiographic imaging studies included CT scans for assessment of osseous integration and anatomic reduction of the bony avulsion. In addition to that posterior stress radiographs of both knees using the Telos device (Arthrex, Naples, USA) were conducted to measure posterior tibial translation. RESULTS: A total of four patients (1 female, 3 male; ø 38 (± 18) years), who underwent arthroscopic refixation of a PCL avulsion fracture using the Tight Rope device were enrolled in this study. Mean follow up was 22 [18-24] months. The mean subjective IKDC was 72.6% (± 9.9%). Regarding the objective IKDC three patients accounted for grade A, one patient for grade C. The Lysholm score yielded 82 (± 6.9) points. The KOOS score reached 75% (± 13%; symptoms 76%, pain 81%, function 76%, sports 66%, QoL 64%). All patients showed complete osseous integration and anatomic reduction of the bony avulsion. The mean posterior tibial translation at final follow up was 2.8 [0-7] mm. CONCLUSIONS: All-arthroscopic treatment of tibial avulsion fractures of the posterior cruciate ligament provides satisfactory clinical results in a preliminary patient cohort. It is a reproducible technique, which minimizes soft tissue damage and obviates a second surgery for hardware removal. Further clinical studies with larger patient cohorts and a control group are needed to further confirm these preliminary results.
RESUMEN
Avulsion fracture of the posterior cruciate ligament from its tibial insertion is a rare condition. Early surgical treatment has been regarded as necessary, but the optimal surgical technique remains unclear. The purpose of this technical note is to present a novel all-inside arthroscopic reconstruction technique for bony tibial avulsion fractures of the posterior cruciate ligament using the TightRope device (Arthrex, Naples, FL).