An interventional study of Intra-articular infiltration of PVP Collagen and Rehabilitation in Gonarthrosis, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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:
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.
INTRODUCTION: Osteoarthritis is a disorder characterized by progressive deterioration of cartilage in synovial joints, affecting more than 55% of the elderly population, causing significant physical disability, implying a great challenge in medical treatment.
MATERIAL AND METHODS: A sequential, simple randomized clinical trial was carried out in patients diagnosed with symptomatic gonarthrosis Grade II-IV, referred to the Physical Medicine and Rehabilitation service in 3 months, through two study groups: GROUP Those who received intra-articular infiltration of Collagen PVP, GROUP B: patients who received conservative treatment through rehabilitation with a home program for one month. In both cases, ENA and the WOMAC scale were evaluated at the beginning of the study and at 4 weeks.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 130 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Instituto Mexicano del Seguro Social is the lead sponsor of 124 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who received intra-articular infiltration of PVP Collagen
Other: Intra-articular infiltration of PVP Collagen
Patients who received conservative treatment through rehabilitation with a home program for one month
Other: Rehabilitation
Intra-articular collagen injection plus physiotherapy program
Also known as: PVP Collagen
Patients who received conservative treatment through rehabilitation with a home program for one month
Western Ontario and McMaster Universities Osteoarthritis Index - Pain
number of patients with none, little, quite a bit, a lot, very much
Time frame: One to three months
Western Ontario and McMaster Universities Osteoarthritis Index - stiffness
number of patientes with none, little, quite a bit, a lot, very much
Time frame: One to Three months
Western Ontario and McMaster Universities Osteoarthritis Index - functionality
number of patients with none, little, quite a bit, a lot, very much
Time frame: One to three months
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)
Time frame: one to three months
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Instituto Mexicano del Seguro Social