Collagen-PVP vs Hylan G-F 20 in the Treatment of Knee Osteoarthritis

NCT07692009 | Completed Phase 4

• 1 other identifier: CEMDEICY-OA26092023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

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)

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)

Device: Hylan G-F 20

Interventions

Collagen-polyvinylpyrrolidone DRUG

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)

Also known as: Fibroquel

Collagen-polyvinylpyrrolidone (Collagen-PVP).

Hylan G-F 20 DEVICE

Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)

Also known as: Synvisc

Hylan G-F 20

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan S.: lead

Study Sites (1)

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

Mérida, Yucatán, 97130, Mexico

Location

Related Publications (6)

• 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.

  PMID: 26956444 BACKGROUND

• Cardiel 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.

  PMID: 12412191 BACKGROUND

• Bennett 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.

  PMID: 9002028 BACKGROUND

• Pelaez-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.

  PMID: 21196592 BACKGROUND

• Kraus 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.

  PMID: 25865392 BACKGROUND

• Wieczorek M, Rat AC. Generalidades sobre la artrosis: epidemiología y factores de riesgo. EMC - Aparato locomotor. 2017; 50(3):1-12.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

collagen-PVP

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 9, 2026
• Study Start: January 23, 2024
• Primary Completion: June 19, 2026
• Study Completion: June 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)