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Completed

NCT Number: NCT04196764

Prospective Observational Study of Pain Evolution in Patients With Primary Knee Osteoarthritis Treated With Pronolis® HD

Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice.

In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study group, but will be carried out in accordance with the usual clinical practice, not applying any intervention other than the usual one in this type of care practice and always in accordance with current clinical guidelines and recommendations and with the indications authorized in Spain.

Patients will be recruited by specialists and will be followed for 6 months under the conditions of usual clinical practice.

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Key information

Conditions

Osteo Arthritis Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of both sexes and over 18 years.
  • Patients with a previous diagnosis of primary knee osteoarthritis according to ACR criteria and who have a knee x-ray performed during the previous 18 months.
  • Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.
  • Patients with pain equal to or greater than 4 on the VAS scale.
  • Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.
  • Patients who have given their written informed consent to participate in the clinical investigation.
  • Patients for whom there is a reasonable expectation of follow-up during the development of clinical research.
  • Patients who understand and can complete the questionnaires and do not have cognitive impairment that prevents it.

Exclusion criteria

  • Patients with known intolerance to hyaluronic acid.
  • Patients with hypersensitivity to intraarticular injections.
  • Patients who present with infection in the knee joint.
  • Patients presenting with a skin disorder or infection in the area of injection or systemic.
  • Coagulation disorders that contraindicate puncture.
  • Patients who have been prescribed intra-articular injection in both knees.
  • Patients diagnosed with autoimmune rheumatologic diseases or connective diseases.
  • Patients diagnosed with microcrystalline diseases.
  • Patients with traumatic history in the study joint.
  • Patients with a surgical history in the study joint.
  • Pregnant or breastfeeding women.

Treatment and study plan

Primary outcomes

  1. evolution of pain in patients diagnosed with primary knee osteoarthritis 3 months after being treated with hyaluronic acid

    Time frame: 3 months

    3-month baseline change in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.

Secondary outcomes

  1. evolution of pain in patients diagnosed with primary knee osteoarthritis during the study

    Time frame: 15 days, 1 and 6 months

    Changes in the domain A score of the WOMAC questionnaire pain will be analyzed to evaluate pain evolution.

  2. Pain evolution in motion

    Time frame: 15 days, 1, 3 and 6 months

    Average score of question A1 of the WOMAC questionnaire will be described at each study visit in order to evaluate pain evolution in motion of the affected joint.

  3. stiffness evolution

    Time frame: 15 days, 1, 3 and 6 months

    Average score of domain B of the WOMAC questionnaire will be described at each study visit in order to evaluate the evolution of the stiffness of the affected joint of the patient. In addition, the changes produced between the follow-up visits and the baseline visit will be studied.

  4. evolution of the patient's functional capacity

    Time frame: 15 days, 1, 3 and 6 months

    Average C domain score of the WOMAC questionnaire will be described at each study visit in orde to assess the evolution of the patient's functional capacity. In addition, the changes produced between the follow-up visits and the baseline visit will be studied.

  5. evolution of the patient's quality of life

    Time frame: 3 months

    Average score in the 5 dimensions of the Health Questionnaire EQ-5D-5L (mobility, personal care, usual activities, pain / discomfort, anxiety / depression) at the baseline visit and the 3 month visit in order to evaluate the evolution of the patient's quality of life. In addition, the changes produced between the 3-month visit and the baseline visit will be studied.

  6. satisfaction degree with Pronolis® HD

    Time frame: 15 days, 1, 3 and 6 months

    A likert type scale will be used to assess the patient's satisfaction degree with study treatment in each of the study visits. The evolution of the satisfaction degree (an 5-point Likert Scale) contains 5 items. Higher scores reflected better satisfaction degree

  7. overall clinical impression

    Time frame: 15 days, 1, 3 and 6 months

    For the evaluation of the overall clinical impression of the change by the patient, the ICG-C score will be described in all follow-up visits.

  8. tolerability of treatment with Pronolis® HD

    Time frame: 15 days, 1, 3 and 6 months

    percentage of patients who present adverse effects to the treatment during the observation period will be described in order to evaluate the tolerability of hyaluronic acid treatment

Sponsors and collaborators

Lead sponsor

Procare Health Iberia S.L.

Industry

Collaborators

  • Adknoma Health Research

Registry information

Official study title

Estudio Observacional Del Seguimiento Prospectivo de la evolución Del Dolor en Pacientes Con Artrosis Primaria de Rodilla Tratados Con Pronolis® HD

Acronym: NO-DOLOR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2019
Registry last updated
Feb 21, 2021

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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