RPCEC00000250已完成1 期

Evaluation of the intra-articular application of a bioactive formulation for the treatment of osteoarthritis: Clinical Trial Phase I-II - ARTROTX

Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico0 个研究点目标入组 50 人开始时间: 2017年8月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment

•1. Patients older than 18 years.
•2. Patients with clinical and radiographic diagnosis of osteoarthritis in the hip, knee, shoulder or mandible.
•3. Patients with severe structural damage to their joint.
•4. Severe and unproven articular symptomatology to conservative treatment and candidates for total joint arthroplasty (joint prosthesis placement).
•5. Signature written informed consent of the patient

•1. Rheumatoid arthritis
•2. Autoimmune diseases
•3. Decompensated systemic disease
•4. Creatinine 1.25 times the normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method).
•5. Blood leucocytes less than 3000 cells / microliter or platelet count less than 100,000 / microliter.
•6. Blood hemoglobin less than 10 g / deciliter.
•7. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or onset of hematuria or proteinuria greater than 300 milligrams / day.
•9. Pregnancy or women of childbearing potential without contraceptive method: salpingoclasia, device or hormonal. Breastfeeding women.
•10. Alcoholism and / or drug addiction.
•11. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin).
•12. Presence of: Cancer
•13. Other pathologies at the discretion of the researcher

发起方

Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico