NCT06275880

Brief 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. 1.\- Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
  2. 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. 3.\- Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 7, 2024

Last Update Submit

February 16, 2024

Conditions

Gonarthrosis

Keywords

GonarthrosisCollagenInfiltration

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

GROUP A

EXPERIMENTAL

Patients who received intra-articular infiltration of PVP Collagen

Other: Intra-articular infiltration of PVP Collagen

GROUP B

ACTIVE COMPARATOR

Patients who received conservative treatment through rehabilitation with a home program for one month

Other: Rehabilitation

Interventions

Intra-articular infiltration of PVP CollagenOTHER

Intra-articular collagen injection plus physiotherapy program

Also known as: PVP Collagen
GROUP A
RehabilitationOTHER

Patients who received conservative treatment through rehabilitation with a home program for one month

GROUP B

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 40 years.
  • Both sexes.
  • Joint stiffness less than 30 minutes.
  • Crepitus in the knee joint.
  • Pain in one or both knees lasting more than three months.
  • Continuous pain Quantified in \>5 Analog Numerical Scale.
  • Patients entitled to the Mexican Social Security Institute.
  • Radiological criteria for gonarthrosis in phases II, III, IV.
  • Patients not candidates for surgical treatment.

You may not qualify if:

  • Rheumatoid arthritis, gout or chondrocalcinosis.
  • Treatment with glucosamine, chondroitin, diacerein, silver non-saponifiables or slow-acting drug in the last three months.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Regional No. 1 Lic. Ignacio García Téllez

Mérida, Yucatán, 97155, Mexico

Location

Related Publications (24)

  • (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.

    BACKGROUND

  • (15) Insall, J.N. Rodilla. New York: Mc. Graw Hill.

    BACKGROUND

  • (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

    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.

    BACKGROUND

  • 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.

    PMID: 32802520RESULT

  • 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.

    PMID: 33807695RESULT

  • 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.

    PMID: 11029555RESULT

  • 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.

    PMID: 33560326RESULT

  • 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.

    PMID: 12296865RESULT

  • 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.

    PMID: 27187002RESULT

  • 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.

    PMID: 26021117RESULT

  • 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.

    PMID: 14719037RESULT

  • 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.

    PMID: 19397687RESULT

  • 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.

    PMID: 19453649RESULT

  • 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.

    PMID: 22545014RESULT

  • 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.

    PMID: 29702786RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

collagen-PVPRehabilitation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Abigail Mariela Arriaga Coria, Physician

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

  • Raúl Morales Reyes, Physician

    Instituto Mexicano del Seguro Social

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 23, 2024

Study Start

April 1, 2023

Primary Completion

July 30, 2023

Study Completion

January 10, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

ME(1)