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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A | Experimental | Patients who received intra-articular infiltration of PVP Collagen |
|
| GROUP B | Active Comparator | Patients who received conservative treatment through rehabilitation with a home program for one month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular infiltration of PVP Collagen | Other | Intra-articular collagen injection plus physiotherapy program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Abigail Mariela Arriaga Coria, Physician | Instituto Mexicano del Seguro Social | Principal Investigator |
| Raúl Morales Reyes, Physician | Instituto Mexicano del Seguro Social | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Regional No. 1 Lic. Ignacio García Téllez | Mérida | Yucatán | 97155 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | (1) C. Montoya y Verdugo, Evolución Clínica de los Pacientes con Gonartosis Tratados Mediante la Aplicación de Colágeno de Polivinilpirrolidona, Orthotips Vol. 8 No 2, 2012. | ||
| Background | (2) M.C. Magaña y Villa, Et Al, Uso de colágeno Polimerizado Tipo I, en el Tratamiento de la Gonartrosis Tipo I, Experiencia en el IMSS, Orthotips. Vol. 8 No 2, 2012. | ||
| Background | (5) John Richmond, David Hunter et al. Treatment of Osteoarthritis of the Knee, Clinical Practice Guidelines Summary, Journal of the American of Orthopedic Surgeons, 591-600. 2009. | ||
| Background | (8) Bermúdez Hickey R. Et Al; Tratamiento de la pseudoartrosis de tibia con colágeno polivinilpirrolidona; Rev Mex Ortop Traum 1999; 13(2): 148-151. | ||
| Background | (9) Campell, C.S. Cirugía Ortopédica. Madrid: Harcourt Brace. | ||
| Background | (11) Alvarez-López A, Fuentes-Véjar R, Soto-Carrasco SR, Nguyen-Pham T, García-Lorenzo Y de la C, Alvarez-López A, et al. Cartílago y gonartrosis. Revista Archivo Médico de Camagüey [Internet]. 2019 Dec 1;23(6):802-13. | ||
| Background | (13) Mary O Connor. Sex Difference in Osteoarthritis if the Knee a Hip. Journal of the American of Orthopedic Surgeons, 15; 522-525. 2007. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C120488 | collagen-PVP |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Rehabilitation | Other | Patients who received conservative treatment through rehabilitation with a home program for one month |
|
| Background | (15) Insall, J.N. Rodilla. New York: Mc. Graw Hill. |
| 29641854 | Background | Salazar-Guzman I, Garfias-Rosas J, Butze-Rangel W. [Comparison of the clinical response to the application of Hylan G-F 20 and collagen-PVP in patients with knee osteoarthritis]. Acta Ortop Mex. 2017 Nov-Dec;31(6):283-286. Spanish. |
| Background | (20) Laboratorios Aspid S.A. de C.V. Fibroquel® DOF. |
| Background | (22) GPC IMSS-329-10 Evidencias y Recomendaciones. Tratamiento Alternativo en Pacientes con Osteoartrosis de Rodilla Grado I-II |
| Background | (23) M.C. Magaña y Villa, Et Al, Uso de colágeno Polimerizado Tipo I, en el Tratamiento no quirugico de la gonartrosis. Experiencia en el IMSS, Orthotips. Vol. 8 No 2, 2012. |
| 32802520 | Result | Borja-Flores A, Macias-Hernandez SI, Hernandez-Molina G, Perez-Ortiz A, Reyes-Martinez E, Belzazar-Castillo de la Torre J, Avila-Jimenez L, Vazquez-Bello MC, Leon-Mazon MA, Furuzawa-Carballeda J, Torres-Villalobos G, Romero-Hernandez F, Albavera-Hernandez C, Perez-Correa J, Castro-Rocha HA. Long-Term Effectiveness of Polymerized-Type I Collagen Intra-Articular Injections in Patients with Symptomatic Knee Osteoarthritis: Clinical and Radiographic Evaluation in a Cohort Study. Adv Orthop. 2020 Jul 22;2020:9398274. doi: 10.1155/2020/9398274. eCollection 2020. |
| 33807695 | Result | Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619. |
| 11029555 | Result | Watterson JR, Esdaile JM. Viscosupplementation: therapeutic mechanisms and clinical potential in osteoarthritis of the knee. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):277-84. doi: 10.5435/00124635-200009000-00001. |
| 33560326 | Result | Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171. |
| 12296865 | Result | Furuzawa-Carballeda J, Rodriquez-Calderon R, Diaz de Leon L, Alcocer-Varela J. Mediators of inflammation are down-regulated while apoptosis is up-regulated in rheumatoid arthritis synovial tissue by polymerized collagen. Clin Exp Immunol. 2002 Oct;130(1):140-9. doi: 10.1046/j.1365-2249.2002.01955.x. |
| 27187002 | Result | Alvarez-Lopez CA, Garcia-Lorenzo YC. [Relationship between angular deformity and primary osteoarthritis of the knee. Review article]. Acta Ortop Mex. 2015 Jul-Aug;29(4):232-6. Spanish. |
| 26021117 | Result | Salvatori-Rubi J, Montiel-Jarquin AJ, Lopez-Cazares G, Barragan-Hervella R, Ortiz-Arellano R, Garcia-Carrasco M, Mendoza-Pinto C. [Total knee replacement due to grade IV gonarthrosis]. Acta Ortop Mex. 2014 May-Jun;28(3):193-6. Spanish. |
| 14719037 | Result | Furuzawa-Carballeda J, Rojas E, Valverde M, Castillo I, Diaz de Leon L, Krotzsch E. Cellular and humoral responses to collagen-polyvinylpyrrolidone administered during short and long periods in humans. Can J Physiol Pharmacol. 2003 Nov;81(11):1029-35. doi: 10.1139/y03-101. |
| 19397687 | Result | Furuzawa-Carballeda J, Munoz-Chable OA, Macias-Hernandez SI, Agualimpia-Janning A. Effect of polymerized-type I collagen in knee osteoarthritis. II. In vivo study. Eur J Clin Invest. 2009 Jul;39(7):598-606. doi: 10.1111/j.1365-2362.2009.02144.x. Epub 2009 Apr 23. |
| 19453649 | Result | Furuzawa-Carballeda J, Munoz-Chable OA, Barrios-Payan J, Hernandez-Pando R. Effect of polymerized-type I collagen in knee osteoarthritis. I. In vitro study. Eur J Clin Invest. 2009 Jul;39(7):591-7. doi: 10.1111/j.1365-2362.2009.02154.x. |
| 22545014 | Result | Furuzawa-Carballeda J, Lima G, Llorente L, Nunez-Alvarez C, Ruiz-Ordaz BH, Echevarria-Zuno S, Hernandez-Cuevas V. Polymerized-type I collagen downregulates inflammation and improves clinical outcomes in patients with symptomatic knee osteoarthritis following arthroscopic lavage: a randomized, double-blind, and placebo-controlled clinical trial. ScientificWorldJournal. 2012;2012:342854. doi: 10.1100/2012/342854. Epub 2012 Apr 1. |
| 29702786 | Result | Burbano-Levy X, Qf DC, Act EP, Alba IR, Qf LZ. Costo Utilidad de Colagena Polivinil-Pirrolidona en el Tratamiento de Osteartrosis de Rodilla en Mexico. Value Health Reg Issues. 2014 Dec;5:40-47. doi: 10.1016/j.vhri.2014.06.006. Epub 2014 Aug 30. |
| D012216 |
| Rheumatic Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |