Osteoarthritis of the knee, hip, shoulder, or jaw joints Osteoarthritis of the Jaw
Conditions
Interventions
Bioactive Formula (US Patent 9089580 B1) (Experimental Group): Intra-articular application of the solution called bioactive formula in affected joint. The amount applied varies according to the joint:
Joint Prosthesis
Surgical Procedures, Operative
Sponsors
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
ESTERIPHARMA
Medical School of the University of Colima, Mexico
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: baseline, 3, 30, 60, 180 and 360 days. Therapeutic efficacy (improvement in quality of life index. Interrogation on joint pain intensity and quality of life; WOMAC, RAPID3 and RASMUSSEN Clinical score). Measurement time: baseline, at 3, 30, 60, 180 and 360 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Full joint improvement: Thickness of articular cartilage by (Magnetic Resonance Imaging analysis of treated joint to assess variations in thickness of articular cartilage). Measurement time: baseline and 12 months. | — |
Countries
Mexico
Contacts
Public ContactIvan Delgado-Enciso
Cancerology State Institute, Colima State Health Service
Outcome results
None listed