sual treatment plus intra-articular application of bioactive formulation for osteoarthritis

Phase 2

Recruiting

• Conditions: Osteoarthritis of the knee, hip, shoulder, or jaw joints; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases; Musculoskeletal Diseases

• Registration Number: RPCEC00000277
• Lead Sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Results First Posted: 2019-03-13
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 350

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. Signature written informed consent of the patient

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.
8. Hematuria or proteinuria greater than 300 milligrams/day.
9. Women who are lactating, pregnant or of childbearing age and sexually active without contraception: salpingoclasm, intrauterine device or hormonal contraceptives. This condition must be maintained for at least 6 months after the last application of the inductive bioactive formulation.
10. Alcoholism and/or drug addiction.
11. Known liver disease with twice the increase in liver function tests (Aspartate aminotransferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin).
12. Presence of Cancer.
13. Other pathologies at the discretion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic efficacy: <br>1) Minimal Clinically Important Improvement-MCII (defined as the smallest change in measurement that signifies an important improvement in a patient’s symptom (VAS, WOMAC, Clinical Rasmussen, RAPID3). It will be calculated through a dichotomous score per outcome, based on 30% improvement from the baseline). Measurement time: baseline, at 90, 180 and 360 days. <br>2) Patient Acceptable Symptom State-PASS (defined as the value of symptoms the patient considers to be the thresholds of well-being for pain and function. This will be assessed with the following question: Taking into account all your daily activities, do you consider your current state satisfactory in relation to pain level and functional impairment?” The response options are Yes” or No”). Measurement time: baseline, at 90, 180 and 360 days.

Secondary Outcome Measures

Name	Time	Method
1) Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3. Bone necrosis or tissues adjacent to the lesion, bone or muscle changes not compatible with a normal anatomy, muscle weakness, nausea, skin atrophy, ecchymosis, changes in skin pigmentation, fibrosis , alterations in the state of consciousness, pain in the area of application, neurological events, alterations in the liver enzymes or blood count, bone fracture, cardiovascular events). Measurement time: baseline, at 30, 90, 180 and 360 days.<br>2) Change in anti-inflammatory non steroidal drugs use. Measurement time: baseline, at 90, 180 and 360 days.