GonarthrosisNCT06275880

Intraarticular Collagen in Patients With Gonarthrosis

A study testing Intra-articular infiltration of PVP Collagen and Rehabilitation in people with Gonarthrosis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for: Gonarthrosis
What is being tested?: Intra-articular infiltration of PVP Collagen and Rehabilitation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteMexico
Study dates: 1 Apr 2023to 10 Jan 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

Patients entitled to the Mexican Social Security Institute.
Radiological criteria for gonarthrosis in phases II, III, IV.
Patients not candidates for surgical treatment.

Who cannot join

Rheumatoid arthritis, gout or chondrocalcinosis.
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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Hospital General Regional No. 1 Lic. Ignacio García Téllez
Mérida, Yucatán, 97155

Other trials in Mexico

About this study

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

- Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
- Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
- 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.

Read the detailed 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.

Conditions: Gonarthrosis
Being tested: Intra-articular infiltration of PVP Collagen, Rehabilitation
Keywords: Gonarthrosis, Collagen, Infiltration
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intra-articular infiltration of PVP CollagenOther
Also called PVP Collagen
Intra-articular collagen injection plus physiotherapy program
RehabilitationOther
Patients who received conservative treatment through rehabilitation with a home program for one month

Study groups in NCT06275880
Study group	Role	What they receive
GROUP A	Experimental	Patients who received intra-articular infiltration of PVP Collagen Receives: 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 Receives: Other: Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Western Ontario and McMaster Universities Osteoarthritis Index - Pain
number of patients with none, little, quite a bit, a lot, very much
Measured: 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
Measured: 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
Measured: 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)
Measured: one to three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202310 Jan 2024

First posted23 Feb 2024
Study start1 Apr 2023
Primary completion30 Jul 2023
Study completion10 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for GonarthrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06275880
Sponsor's protocol ID: F-2023-3201-066
Status last verified: Feb 2024
First submitted: 7 Feb 2024
Last updated: 23 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

(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.
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.
PubMed 29641854
(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.
PubMed 32802520
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.
PubMed 33807695
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.
PubMed 11029555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Gonarthrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Intra-articular Collagen Polyvinylpyrrolidone in Patients With Symptomatic Gonarthross Attended in Rehabilitation of an IMSS-Yucatán Hospital.
ClinicalTrials.gov ID: NCT06275880
Acronym / sponsor ID: F-2023-3201-066
Conditions: Gonarthrosis
Keywords: Gonarthrosis, Collagen, Infiltration
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Study start: 1 Apr 2023 (actual)
Primary completion: 30 Jul 2023 (actual)
Study completion: 10 Jan 2024 (actual)
First posted: 23 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

- Document the effectiveness of intra-articular polyvinylpyrrolidone collagen in the treatment of symptomatic gonarthrosis.
- Compare the intensity of pain, the degree of stiffness and functionality of the joint, prior to application and one month after the therapeutic intervention.
- Identify demographic, clinical and therapeutic factors that influence the effectiveness of intra-articular PVP collagen in the treatment of symptomatic gonarthrosis.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GROUP A	Experimental	Other: Intra-articular infiltration of PVP CollagenPatients who received intra-articular infiltration of PVP Collagen
GROUP B	Active comparator	Other: RehabilitationPatients who received conservative treatment through rehabilitation with a home program for one month

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (3 listed)

Rheumatoid arthritis, gout or chondrocalcinosis.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intra-articular infiltration of PVP CollagenAlso: PVP CollagenIntra-articular collagen injection plus physiotherapy program	Other	GROUP A
RehabilitationPatients who received conservative treatment through rehabilitation with a home program for one month	Other	GROUP B

Primary outcome

Western Ontario and McMaster Universities Osteoarthritis Index - Pain
Time frame: One to three months
number of patients with none, little, quite a bit, a lot, very much
Western Ontario and McMaster Universities Osteoarthritis Index - stiffness
Time frame: One to Three months
number of patientes with none, little, quite a bit, a lot, very much
Western Ontario and McMaster Universities Osteoarthritis Index - functionality
Time frame: One to three months
number of patients with none, little, quite a bit, a lot, very much
Number Analog Scale for pain
Time frame: one to three months
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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.
Background(15) Insall, J.N. Rodilla. New York: Mc. Graw Hill.
Background: PubMed 29641854Salazar-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.

Related trials for Gonarthrosis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abigail Mariela Arriaga Coria, Physician principal investigator

Instituto Mexicano del Seguro Social

Raúl Morales Reyes, Physician study chair

Instituto Mexicano del Seguro Social

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intra-articular infiltration of PVP Collagen and Rehabilitation in people with Gonarthrosis, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Ontario and McMaster Universities Osteoarthritis Index - Pain (time frame: One to three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275880, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.