Intraarticular Collagen in Patients With Gonarthrosis

Gonarthrosis Clinical Trial

Official title:

Effectiveness of Intra-articular Collagen Polyvinylpyrrolidone in Patients With Symptomatic Gonarthross Attended in Rehabilitation of an IMSS-Yucatán Hospital.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275880
• Other study ID #: F-2023-3201-066
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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

Locations

Country	Name	City	State
Mexico	Hospital General Regional No. 1 Lic. Ignacio García Téllez	Mérida	Yucatán

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

References & Publications (24)

(1) C. Montoya y Verdugo, Evolucio´n Cli´nica de los Pacientes con Gonartosis Tratados Mediante la Aplicacio´n de Cola´geno de Polivinilpirrolidona, Orthotips Vol. 8 No 2, 2012.

(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

(2) M.C. Magan~a y Villa, Et Al, Uso de cola´geno Polimerizado Tipo I, en el Tratamiento de la Gonartrosis Tipo I, Experiencia en el IMSS, Orthotips. Vol. 8 No 2, 2012.

(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. Magan~a y Villa, Et Al, Uso de cola´geno Polimerizado Tipo I, en el Tratamiento no quirugico de la gonartrosis. 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) Bermu´dez Hickey R. Et Al; Tratamiento de la pseudoartrosis de tibia con cola´geno polivinilpirrolidona; Rev Mex Ortop Traum 1999; 13(2): 148-151.

(9) Campell, C.S. Cirugi´a Ortope´dica. Madrid: Harcourt Brace.

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. — View Citation

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 — View Citation

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. — View Citation

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 follow — View Citation

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. — View Citation

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 — View Citation

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): — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

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