Osteoarthritis (OA) of the KneePhase 426092023NCT07692009
Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis
A Phase 4 study testing Collagen-polyvinylpyrrolidone and Hylan G-F 20 in people with Osteoarthritis (OA) of the Knee, run by Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S. at 1 site in Mexico.
Trial summary
Abstract Title: "Efficacy of intra-articular polyvinylpyrrilidone collagen in the treatment of Kellgren-Lawrence grade II-III primary knee osteoarthritis compared to Hilano G-F 20: a controlled clinical trial." Investigators: Efren Alberto Sanchez Campos, Multidisciplinary Center for the Specialized Development of… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Collagen-polyvinylpyrrolidone and Hylan G-F 20
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 23 Jan 2024to 30 Jun 2026
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary acceptance to sign the informed consent form and commitment to attend all scheduled visits, follow the treatment plan, undergo medical evaluations, and complete all procedures of the clinical trial.
- Participants must be between 40 and 70 years of age at the time of signing the informed consent form.
- Clinical and radiographic diagnosis of primary knee osteoarthritis, Kellgren-Lawrence grade II and III. The reference radiographic study for Kellgren-Lawrence stratification must be no more than 6 months old.
- Presence of knee joint pain with an intensity ≥4 on a scale of 0 to 10 in question 1 of the average pain experienced during the last week of the assessment (Spanish version of the MOS Pain Severity Scale - MOS-PSS).
- Failure of conservative non-pharmacological treatment.
- Failure of pharmacological treatment with NSAIDs and/or failure of intra-articular corticosteroid treatment.
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- BMI ≥25 and <45 kg/m².
- Commitment to comply with the activities and procedures of the clinical trial in a timely manner.
- Maintaining the diet and any physical activity performed by the participant prior to signing the informed consent form for the clinical trial, without radical or significant changes throughout the duration of this clinical trial.
- Women of reproductive potential must use a highly effective method of family planning.
Who cannot join
- Participants with high-impact physical activity.
- Participants with acute arthritis of the knee.
- Participants on anticoagulants or with any contraindication to intra-articular infiltration (skin infection); participants requiring prophylactic doses of ASA.
- Participants treated with oral or injectable glucocorticoids within the last 90 days.
- Participants who have undergone intra-articular infiltration with glucocorticoids or viscosupplementation within the last 90 days.
- Participants who have undergone arthroscopy within the last 6 months.
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- Participants with secondary osteoarthritis: Acromegaly, Hemochromatosis, and Hemophilia.
- Participants with coexisting Rheumatoid Arthritis, Axial or Peripheral Spondyloarthritis, Systemic Lupus Erythematosus, Fibromyalgia, or any other rheumatic disease that may cause secondary osteoarthritis.
- History of allergy to hyaluronic acid derivatives or any component constituent of the study treatments.
- Presence of varus or valgus deformity >15 degrees, or a flexion contracture >20 degrees.
- Women undergoing estrogen replacement therapy.
- Pregnant or breastfeeding women.
- Presence of any disease that, in the investigator's judgment, predisposes the patient to an additional risk by participating in this clinical trial (poorly controlled disease, psychiatric disorders, cancer, etc.).
- Immediate relatives (parents, spouses, siblings, children) of the research team, or any member of the research team (Conflict of interest).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, 97130
About this study
Official title: Efficacy Evaluation of Intraarticular Collagen-polyvinylpyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-groups, Non-inferiority Study
Abstract
Title: "Efficacy of intra-articular polyvinylpyrrilidone collagen in the treatment of Kellgren-Lawrence grade II-III primary knee osteoarthritis compared to Hilano G-F 20: a controlled clinical trial."
Read more
Investigators: Efren Alberto Sanchez Campos, Multidisciplinary Center for the Specialized Development of Clinical Research in Yucatan; Gabriel Jose Horta Baas, Rheumatology Service, HGR 1, Merida, Yucatan.
Number of participating centers: One participating clinical research center with 32 randomized participants.
Theoretical framework: The loss of articular collagen occurs naturally as part of the aging process, but it intensifies with osteoarthritis (OA). OA is the most common joint disease and one of the leading causes of disability and dependency in the adult population, generating high healthcare costs. Knee osteoarthritis is gaining importance due to its increasing prevalence resulting from the rise in average life expectancy and obesity.
Cartilage loss is the main characteristic of osteoarthritis (OA). Enzymatic and inflammatory mechanisms participate in the degradation of articular cartilage, contributing to the chronic nature of OA. Because articular cartilage has a limited regenerative capacity, intra-articular medications have been developed to reduce inflammation and lead to clinical improvement in patients.
Intra-articular treatment is not recommended by guidelines as first-line therapy. However, it is recommended by some scientific societies for patients who do not experience symptomatic relief with non-pharmacological treatment, who do not respond to pharmacological treatment, or who have a contraindication for joint surgery. In this regard, the most commonly used medical devices are hyaluronic acid and its derivatives, but their use is limited by their cost, the method of administration, and conflicting evidence regarding their efficacy.
Given the important role of collagen in the proper functioning of the musculoskeletal system and the alterations in protein metabolism in osteoarthritis (OA), it seems reasonable that its intra-articular administration could slow the degenerative process. Over the past two decades, preclinical research studies have shown that Collagen-PVP stimulates cartilage regeneration at the molecular level, and research studies have demonstrated a reduction in pain and improvement in joint function in subjects with knee OA. However, major scientific societies do not mention or cannot recommend for or against the use of Collagen-PVP for the treatment of knee OA, based on a lack of high-quality studies and questions regarding its clinical relevance. According to the manufacturer's recommendations, 3 to 6 weekly injections are suggested, at the physician's discretion. However, no established dosage regimen is provided, and any such regimen should be supported by evidence-based medicine. In the context of knee osteoarthritis (OA), doubts remain regarding the efficacy of collagen-PVP. These controversies suggest that further research on the efficacy of this medication is necessary.
Furthermore, the average cost of treatment with collagen-PVP is lower than that of hyaluronate G-F 20. In the Mexican context, a cost-utility study reported that collagen-PVP represents a cost-effective alternative in the treatment of OA compared to the standard treatment recommended in national clinical guidelines.
Objective: To compare the clinical efficacy of intra-articular treatment with collagen-PVP with hyaluronate G-F 20, evaluated by the International Knee Committee (IKDC) functional scale score at 6 months in subjects with Kellgren-Lawrence grade II-III primary knee osteoarthritis residing in the Yucatán Peninsula.
Materials and Methods: A randomized, double-blind, controlled clinical trial was conducted at a single private clinical research center. The sample size will be 16 subjects per study group. Group assignment will be performed using a permuted random sampling method. Non-inferiority analysis will be based on a Student's t-test. Statistical analysis will include an intention-to-treat analysis.
Resources and Infrastructure: The Multidisciplinary Center for Specialized Clinical Research Development in Yucatán has the necessary infrastructure to perform arthrocentesis, joint infiltration, and the management of potential complications, as well as the storage, control, inventory, and preparation of medications for the clinical trial and rescue therapy. The team is qualified to carry out the study procedures. Evaluation methods primarily rely on patient-reported outcomes, and validated instruments are available for measuring the outcomes of interest.
Read the detailed description
Group Experience: The research group has the experience to conduct the proposed research project; it has training in the research field and publications in the area of clinimetric evaluation in subjects with rheumatic and other chronic diseases. It includes an Associate Researcher (Level C) who is also a member of the National System of Researchers.
Timeframe: 12 months.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Collagen-polyvinylpyrrolidone, Hylan G-F 20
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen-polyvinylpyrrolidoneDrug
Also called Fibroquel
Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days)
Hylan G-F 20Device
Also called Synvisc
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
| Study group | Role | What they receive |
|---|---|---|
| Collagen-polyvinylpyrrolidone (Collagen-PVP). | Experimental | Collagen-PVP:
Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (Collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days) Receives: Drug: Collagen-polyvinylpyrrolidone |
| Hylan G-F 20 | Active comparator | Hylan G-F 20:
Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days) Receives: Device: Hylan G-F 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC (International Knee Documentation Committee) Subjective Knee Form
IKDC is a patient-reported outcome instrument, specific to the knee, designed to assess symptoms, function, and level of athletic activity in individuals with various knee pathologies. It was developed as a unidimensional measure, valid for summarizing the patient's perceived clinical status in a single score.
Although the IKDC-SKF is often described as a 10-item questionnaire, its scoring structure actually includes 18 quantifiable responses. The maximum raw score on the IKDC-SKF is not 100, which is then linearly transformed to a scale of 0 to 100, where higher values represent better function, fewer symptoms, and a higher level of activity.
IKDC score = (raw score obtained / 87) × 100
A score of 100 represents the absence of functional limitations and relevant symptoms, while lower scores reflect greater clinical impairment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start23 Jan 2024
- Primary completion19 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in one group receive Drug A (Collagen-PVP) "in parallel" to participants in the other group, who receive drug B (Hylan G-F 20).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efren Alberto Sanchez Campos, Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692009
- Sponsor's protocol ID
- CEMDEICY-OA26092023
- Acronym
- 26092023
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD not be shared
Publications
Del Rio Najera D, Santana N, Pelaez-Ballestas I, Gonzalez-Chavez SA, Quinonez-Flores CM, Pacheco-Tena C. Prevalence of rheumatic diseases in Raramuri people in Chihuahua, Mexico: a community-based study. Clin Rheumatol. 2016 Jul;35 Suppl 1(Suppl 1):43-52. doi: 10.1007/s10067-016-3225-x. Epub 2016 Mar 8.
PubMed 26956444Cardiel MH, Rojas-Serrano J. Community based study to estimate prevalence, burden of illness and help seeking behavior in rheumatic diseases in Mexico City. A COPCORD study. Clin Exp Rheumatol. 2002 Sep-Oct;20(5):617-24.
PubMed 12412191Bennett K, Cardiel MH, Ferraz MB, Riedemann P, Goldsmith CH, Tugwell P. Community screening for rheumatic disorder: cross cultural adaptation and screening characteristics of the COPCORD Core Questionnaire in Brazil, Chile, and Mexico. The PANLAR-COPCORD Working Group. Pan American League of Associations for Rheumatology. Community Oriented Programme for the Control of Rheumatic Disease. J Rheumatol. 1997 Jan;24(1):160-8.
PubMed 9002028Pelaez-Ballestas I, Sanin LH, Moreno-Montoya J, Alvarez-Nemegyei J, Burgos-Vargas R, Garza-Elizondo M, Rodriguez-Amado J, Goycochea-Robles MV, Madariaga M, Zamudio J, Santana N, Cardiel MH; Grupo de Estudio Epidemiologico de Enfermedades Musculo Articulares (GEEMA). Epidemiology of the rheumatic diseases in Mexico. A study of 5 regions based on the COPCORD methodology. J Rheumatol Suppl. 2011 Jan;86:3-8. doi: 10.3899/jrheum.100951.
PubMed 21196592Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
PubMed 25865392Wieczorek M, Rat AC. Generalidades sobre la artrosis: epidemiología y factores de riesgo. EMC - Aparato locomotor. 2017; 50(3):1-12.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Intraarticular Collagen-polyvinylpyrrolidone (Fibroquel®) vs Hylan G-F 20 (Synvisc®) in the Treatment of Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-groups, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT07692009
- Acronym / sponsor ID
- 26092023 / CEMDEICY-OA26092023
- Conditions
- Osteoarthritis (OA) of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.Research network
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Jul 2026 (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.
Abstract
Title: "Efficacy of intra-articular polyvinylpyrrilidone collagen in the treatment of Kellgren-Lawrence grade II-III primary knee osteoarthritis compared to Hilano G-F 20: a controlled clinical trial."
Investigators: Efren Alberto Sanchez Campos, Multidisciplinary Center for the Specialized Development of Clinical Research in Yucatan; Gabriel Jose Horta Baas, Rheumatology Service, HGR 1, Merida, Yucatan.
Number of participating centers: One participating clinical research center with 32 randomized participants.
Theoretical framework: The loss of articular collagen occurs naturally as part of the aging process, but it intensifies with osteoarthritis (OA). OA is the most common joint disease and one of the leading causes of disability and dependency in the adult population, generating high healthcare costs. Knee osteoarthritis is gaining importance due to its increasing prevalence resulting from the rise in average life expectancy and obesity.
Cartilage loss is the main characteristic of osteoarthritis (OA). Enzymatic and inflammatory mechanisms participate in the degradation of articular cartilage, contributing to the chronic nature of OA. Because articular cartilage has a limited regenerative capacity, intra-articular medications have been developed to reduce inflammation and lead to clinical improvement in patients.
Intra-articular treatment is not recommended by guidelines as first-line therapy. However, it is recommended by some scientific societies for patients who do not experience symptomatic relief with non-pharmacological treatment, who do not respond to pharmacological treatment, or who have a contraindication for joint surgery. In this regard, the most commonly used medical devices are hyaluronic acid and its derivatives, but their use is limited by their cost, the method of administration, and conflicting evidence regarding their efficacy.
Given the important role of collagen in the proper functioning of the musculoskeletal system and the alterations in protein metabolism in osteoarthritis (OA), it seems reasonable that its intra-articular administration could slow the degenerative process. Over the past two decades, preclinical research studies have shown that Collagen-PVP stimulates cartilage regeneration at the molecular level, and research studies have demonstrated a reduction in pain and improvement in joint function in subjects with knee OA. However, major scientific societies do not mention or cannot recommend for or against the use of Collagen-PVP for the treatment of knee OA, based on a lack of high-quality studies and questions regarding its clinical relevance. According to the manufacturer's recommendations, 3 to 6 weekly injections are suggested, at the physician's discretion. However, no established dosage regimen is provided, and any such regimen should be supported by evidence-based medicine. In the context of knee osteoarthritis (OA), doubts remain regarding the efficacy of collagen-PVP. These controversies suggest that further research on the efficacy of this medication is necessary.
Furthermore, the average cost of treatment with collagen-PVP is lower than that of hyaluronate G-F 20. In the Mexican context, a cost-utility study reported that collagen-PVP represents a cost-effective alternative in the treatment of OA compared to the standard treatment recommended in national clinical guidelines.
Objective: To compare the clinical efficacy of intra-articular treatment with collagen-PVP with hyaluronate G-F 20, evaluated by the International Knee Committee (IKDC) functional scale score at 6 months in subjects with Kellgren-Lawrence grade II-III primary knee osteoarthritis residing in the Yucatán Peninsula.
Materials and Methods: A randomized, double-blind, controlled clinical trial was conducted at a single private clinical research center. The sample size will be 16 subjects per study group. Group assignment will be performed using a permuted random sampling method. Non-inferiority analysis will be based on a Student's t-test. Statistical analysis will include an intention-to-treat analysis.
Resources and Infrastructure: The Multidisciplinary Center for Specialized Clinical Research Development in Yucatán has the necessary infrastructure to perform arthrocentesis, joint infiltration, and the management of potential complications, as well as the storage, control, inventory, and preparation of medications for the clinical trial and rescue therapy. The team is qualified to carry out the study procedures. Evaluation methods primarily rely on patient-reported outcomes, and validated instruments are available for measuring the outcomes of interest.
Detailed description
Group Experience: The research group has the experience to conduct the proposed research project; it has training in the research field and publications in the area of clinimetric evaluation in subjects with rheumatic and other chronic diseases. It includes an Associate Researcher (Level C) who is also a member of the National System of Researchers.
Timeframe: 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in one group receive Drug A (Collagen-PVP) "in parallel" to participants in the other group, who receive drug B (Hylan G-F 20).
| Arm | Type | Receives |
|---|---|---|
| Collagen-polyvinylpyrrolidone (Collagen-PVP). | Experimental | Drug: Collagen-polyvinylpyrrolidoneCollagen-PVP: Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (Collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days) |
| Hylan G-F 20 | Active comparator | Device: Hylan G-F 20Hylan G-F 20: Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary acceptance to sign the informed consent form and commitment to attend all scheduled visits, follow the treatment plan, undergo medical evaluations, and complete all procedures of the clinical trial.
- Participants must be between 40 and 70 years of age at the time of signing the informed consent form.
- Clinical and radiographic diagnosis of primary knee osteoarthritis, Kellgren-Lawrence grade II and III. The reference radiographic study for Kellgren-Lawrence stratification must be no more than 6 months old.
- Presence of knee joint pain with an intensity ≥4 on a scale of 0 to 10 in question 1 of the average pain experienced during the last week of the assessment (Spanish version of the MOS Pain Severity Scale - MOS-PSS).
- Failure of conservative non-pharmacological treatment.
Key exclusion criteria (14 listed)
- Participants with high-impact physical activity.
- Participants with acute arthritis of the knee.
- Participants on anticoagulants or with any contraindication to intra-articular infiltration (skin infection); participants requiring prophylactic doses of ASA.
- Participants treated with oral or injectable glucocorticoids within the last 90 days.
- Participants who have undergone intra-articular infiltration with glucocorticoids or viscosupplementation within the last 90 days.
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 |
|---|---|---|
| Collagen-polyvinylpyrrolidoneAlso: FibroquelInfiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days) | Drug | Collagen-polyvinylpyrrolidone (Collagen-PVP). |
| Hylan G-F 20Also: SynviscInfiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days) | Device | Hylan G-F 20 |
Primary outcome
IKDC (International Knee Documentation Committee) Subjective Knee Form
Time frame: 6 months
IKDC is a patient-reported outcome instrument, specific to the knee, designed to assess symptoms, function, and level of athletic activity in individuals with various knee pathologies. It was developed as a unidimensional measure, valid for summarizing the patient's perceived clinical status in a single score. Although the IKDC-SKF is often described as a 10-item questionnaire, its scoring structure actually includes 18 quantifiable responses. The maximum raw score on the IKDC-SKF is not 100, which is then linearly transformed to a scale of 0 to 100, where higher values represent better function, fewer symptoms, and a higher level of activity. IKDC score = (raw score obtained / 87) × 100 A score of 100 represents the absence of functional limitations and relevant symptoms, while lower scores reflect greater clinical impairment.
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 9 Jul 2026.
- Background: PubMed 26956444Del Rio Najera D, Santana N, Pelaez-Ballestas I, Gonzalez-Chavez SA, Quinonez-Flores CM, Pacheco-Tena C. Prevalence of rheumatic diseases in Raramuri people in Chihuahua, Mexico: a community-based study. Clin Rheumatol. 2016 Jul;35 Suppl 1(Suppl 1):43-52. doi: 10.1007/s10067-016-3225-x. Epub 2016 Mar 8.
- Background: PubMed 12412191Cardiel MH, Rojas-Serrano J. Community based study to estimate prevalence, burden of illness and help seeking behavior in rheumatic diseases in Mexico City. A COPCORD study. Clin Exp Rheumatol. 2002 Sep-Oct;20(5):617-24.
- Background: PubMed 9002028Bennett K, Cardiel MH, Ferraz MB, Riedemann P, Goldsmith CH, Tugwell P. Community screening for rheumatic disorder: cross cultural adaptation and screening characteristics of the COPCORD Core Questionnaire in Brazil, Chile, and Mexico. The PANLAR-COPCORD Working Group. Pan American League of Associations for Rheumatology. Community Oriented Programme for the Control of Rheumatic Disease. J Rheumatol. 1997 Jan;24(1):160-8.
- Background: PubMed 21196592Pelaez-Ballestas I, Sanin LH, Moreno-Montoya J, Alvarez-Nemegyei J, Burgos-Vargas R, Garza-Elizondo M, Rodriguez-Amado J, Goycochea-Robles MV, Madariaga M, Zamudio J, Santana N, Cardiel MH; Grupo de Estudio Epidemiologico de Enfermedades Musculo Articulares (GEEMA). Epidemiology of the rheumatic diseases in Mexico. A study of 5 regions based on the COPCORD methodology. J Rheumatol Suppl. 2011 Jan;86:3-8. doi: 10.3899/jrheum.100951.
- Background: PubMed 25865392Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
- BackgroundWieczorek M, Rat AC. Generalidades sobre la artrosis: epidemiología y factores de riesgo. EMC - Aparato locomotor. 2017; 50(3):1-12.
- Individual participant dataSharing planned: No. IPD not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagen-polyvinylpyrrolidone and Hylan G-F 20 in people with Osteoarthritis (OA) of the Knee, run by Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S. 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 10 inclusion and 14 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 9 Jul 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IKDC (International Knee Documentation Committee) Subjective Knee Form (time frame: 6 months). 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 NCT07692009, which also lists 6 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 9 Jul 2026.