Study Results
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Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2023-04-01
2024-01-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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GROUP A
Patients who received intra-articular infiltration of PVP Collagen
Intra-articular infiltration of PVP Collagen
Intra-articular collagen injection plus physiotherapy program
GROUP B
Patients who received conservative treatment through rehabilitation with a home program for one month
Rehabilitation
Patients who received conservative treatment through rehabilitation with a home program for one month
Interventions
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Intra-articular infiltration of PVP Collagen
Intra-articular collagen injection plus physiotherapy program
Rehabilitation
Patients who received conservative treatment through rehabilitation with a home program for one month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
Yes
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Roberto Carlos Pech Arguelles
Clinical Professor
Principal Investigators
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Abigail Mariela Arriaga Coria, Physician
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Raúl Morales Reyes, Physician
Role: STUDY_CHAIR
Instituto Mexicano del Seguro Social
Locations
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Hospital General Regional No. 1 Lic. Ignacio García Téllez
Mérida, Yucatán, Mexico
Countries
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References
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(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.
(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.
(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.
(8) Bermúdez Hickey R. Et Al; Tratamiento de la pseudoartrosis de tibia con colágeno polivinilpirrolidona; Rev Mex Ortop Traum 1999; 13(2): 148-151.
(9) Campell, C.S. Cirugía Ortopédica. Madrid: Harcourt Brace.
(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.
(13) Mary O Connor. Sex Difference in Osteoarthritis if the Knee a Hip. Journal of the American of Orthopedic Surgeons, 15; 522-525. 2007.
(15) Insall, J.N. Rodilla. New York: Mc. Graw Hill.
(16) Salazar-Guzmán I, Garfias- Rosas J, Butze-Rangel W. Mejoria clinica y de la calidad de vida a la aplicación de hialino GF-20 y colageno PVP en pacientes con artrosis de rodilla. Rev Esp Med Quir, 2017;22(1):14-21
(20) Laboratorios Aspid S.A. de C.V. Fibroquel® DOF.
(22) GPC IMSS-329-10 Evidencias y Recomendaciones. Tratamiento Alternativo en Pacientes con Osteoartrosis de Rodilla Grado I-II
(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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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F-2023-3201-066
Identifier Type: -
Identifier Source: org_study_id
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