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NCT Number: NCT06275880

Intraarticular Collagen in Patients With Gonarthrosis

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.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Regional No. 1 Lic. Ignacio García Téllez

Mérida, Yucatán, 97155, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Intra-articular infiltration of PVP Collagen

Other

Intra-articular collagen injection plus physiotherapy program

Other names: PVP Collagen

rehabilitation

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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