Gonarthrosis Clinical Trial
Official title:
Effectiveness of Intra-articular Collagen Polyvinylpyrrolidone in Patients With Symptomatic Gonarthross Attended in Rehabilitation of an IMSS-Yucatán Hospital.
Verified date | February 2024 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following: 1. - Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis. 2. - Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention. 3. - Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis. Patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service within 3 months, will be selected. Two study groups will be assigned: GROUP those who received intra-articular infiltration of PVP Collagen, GROUP B: patients who received conservative treatment. Through rehabilitation with a home program for one month, in both cases, ENA and the WOMAC scale will be evaluated at the beginning of the study and after 4 weeks.
Status | Completed |
Enrollment | 130 |
Est. completion date | January 10, 2024 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: 1. Age over 40 years. 2. Both sexes. 3. Joint stiffness less than 30 minutes. 4. Crepitus in the knee joint. 5. Pain in one or both knees lasting more than three months. 6. Continuous pain Quantified in >5 Analog Numerical Scale. 7. Patients entitled to the Mexican Social Security Institute. 8. Radiological criteria for gonarthrosis in phases II, III, IV. 9. Patients not candidates for surgical treatment. Exclusion Criteria: 1. Rheumatoid arthritis, gout or chondrocalcinosis. 2. Treatment with glucosamine, chondroitin, diacerein, silver non-saponifiables or slow-acting drug in the last three months. 4. Anticoagulant treatment. 5. Paget's disease. 6. Treatment with viscosupplementation in the last six months. 7. Patients not entitled to the Mexican Social Security Institute. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital General Regional No. 1 Lic. Ignacio García Téllez | Mérida | Yucatán |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social |
Mexico,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Western Ontario and McMaster Universities Osteoarthritis Index - Pain | number of patients with none, little, quite a bit, a lot, very much | One to three months | |
Primary | Western Ontario and McMaster Universities Osteoarthritis Index - stiffness | number of patientes with none, little, quite a bit, a lot, very much | One to Three months | |
Primary | Western Ontario and McMaster Universities Osteoarthritis Index - functionality | number of patients with none, little, quite a bit, a lot, very much | One to three months | |
Primary | Number Analog Scale for pain | number of patients with 0 (none), 1-2 (very mild pain), 3-4 (mild pain), 5-6 (moderate pain), 7-9 (severe non-disabling pain), 10 (worts pain of life, disabling pain) | one to three months |
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