Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
Autologous platelet rich plasma and 5% dextrose solution injections.
Artritis+2
+ Enfermedades de las Articulaciones
+ Enfermedades del sistema musculoesquelético
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 2019
Fecha en la que se inscribió al primer participante.Our previous study has documented that knee IA PRP injection combined with PRP injection to the pes anserine complex offered better treatment effectiveness as compared with IA PRP alone. In this two-year study, patients with moderate to severe degrees of knee OA will be recruited and divided into 3 groups. The high frequency PRP injection method will be applied (weekly PRP injections for a total of 3 weeks). Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution. We hypothesize that patients in group 3 will have better treatment outcomes. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Upon the completion of this study, we will be able to gather adequate scientific evidences as to which injection approach and what PRP injection frequency is a better option in treating patients with moderate to severe degrees of knee OA.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 36 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 45 a 85 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited. 2. The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance. 3. Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study. 4. Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function. The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region. Exclusion Criteria: 1. Total obliteration of knee joint as shown on the roentgenogram images. Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus \>5°, valgus \>5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression. 2. Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest 3. Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Chang Gung Memorial Hospital
Taoyuan District, TaiwanAbrir Chang Gung Memorial Hospital en Google Maps