E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Knee osteoarthritis |
Artrosis de rodilla |
|
E.1.1.1 | Medical condition in easily understood language |
Knee osteoarthritis |
Artrosis de rodilla |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of PRGF ®-Endoret ® in patients with knee osteoarthritis, by means of combination of intraosseous with intra-articular injections. |
Evaluar la eficacia y seguridad del PRGF®-Endoret® en pacientes con artrosis de rodilla, combinando infiltraciones intraóseas con infiltraciones intraarticulares. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes aged 40 to 72 years. Monocomparitemental internal tibiofemoral osteoarthritis knee diagnosed by radiological clinical study. Joint Pain or above 2.5 VAS points. Radiographic severity grades 3 and 4 according to the scale Ahlbäck. Values ??of Body Mass Index between 20 and 30. Possibility for observation during the follow up period. |
Pacientes de ambos sexos con edades comprendidas entre los 40 y los 72 años. Diagnosticados de artrosis monocomparitemental tibio-femoral interna de rodilla mediante estudio clínico radiológico. Dolor en la articulación igual o superior a 2,5 puntos en EAV. Severidad radiológica grados 3 y 4 según la escala Ahlbäck. Valores de Índice de Masa Corporal entre 20 y 30. Posibilidad para observación durante el periodo de seguimiento. |
|
E.4 | Principal exclusion criteria |
Bilateral knee osteoarthritis in both knees that requires infiltration BMI> 30 Polyarticular disease diagnosed. Severe mechanical deformity (4th varus and16th valgus bidiafisarios ) Arthroscopy in the last year prior. Intraarticular infiltration of hyaluronic acid in the past 6 months. Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%) Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9). Be undergoing immunosuppressive therapy and / or warfarin. Treatment with corticosteroids during the 6 months prior to inclusion in the study. |
Gonartrosis bilateral que requiera infiltración en ambas rodillas Índice de masa corporal>30 Enfermedad poliarticular diagnosticada. Deformidad mecánica severa (varo 4º y valgo 16º bidiafisarios) Artroscopia previa en el último año. Infiltración intraarticular de ácido hialurónico en los 6 últimos meses. Enfermedad reumática autoinmune sistémica (enfermedades del tejido conectivo y vasculitis necrotizantes sistémicas). Diabetes Mellitus mal controlada (hemoglobina glicosilada superior al 9%) Alteraciones hematológicas (trombopatía, trombopenia, anemias con Hb<9). Estar siendo sometido a tratamientos inmunosupresores y/o dicumarínicos. Tratamiento mediante corticoides durante los 6 meses anteriores a su inclusión en el estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinically significant pain improvement according to KOOS scale (Knee injury and Osteoarthritis Outcome Scoredolor) |
Mejoría dolor clínicamente significativa KOOS (Knee injury and Osteoarthritis Outcome Scoredolor) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Symptom improvement clinically significant (KOOS). Improved performance of daily activities clinically significant (KOOS). Improved quality of life clinically significant (SF-12v2). Degree of joint mobility (mobility Arco determined by goniometer) Paracetamol consumption |
Mejoría de los síntomas clínicamente significativa (KOOS). Mejoría desempeño de las actividades cotidianas clínicamente significativa (KOOS). Mejoría de la calidad de vida clínicamente significativa (SF-12v2). Grado de movilidad articular (Arco de movilidad determinado mediante goniómetro) Consumo de paracetamol |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |