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Completed

NCT Number: NCT04757051

Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis

PMCF study to assess the effectiveness and safety of BENART in the treatment of symptomatic knee OA in a real-life clinical setting when used according to the instructions for use.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxiszentrum Elisengalerie

Aachen, 52062, Germany

Who can participate

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

Inclusion criteria

  • male or female aged between 18 and 99 years
  • diagnosis of symptomatic knee OA: Kellgren & Lawrence grade II/III
  • physician's recommendation to use BENART TM prior to recruitment
  • signed informed consent

Exclusion criteria

  • known allergy or hypersensitivity to any of the BENART TM components
  • infection or skin disease at or around the injection site
  • severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)
  • history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)
  • evidence of lymphatic or venous stasis or serious blood disorders
  • known pregnancy or breast feeding
  • significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)
  • individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)

Treatment and study plan

Primary outcomes

  1. Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline

    Time frame: week 1, week 12, week 24, week 36

    Knee injury and Osteoarthritis Outcome Score (KOOS) to assess pain, other symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec) and knee-related Quality of Life (QoL) on a 5-point Likert scale

  2. Change of pain intensity compared to baseline (visual analogue scale, VAS)

    Time frame: week 1, week 12, week 24, week 36

    Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain.

  3. Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)

    Time frame: week 1, week 12, week 24, week 36

    The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition).

  4. Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)

    Time frame: week 1, week 12, week 24, week 36

    The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition).

  5. Responder rate according to OMERACT-OARSI criteria

    Time frame: week 24

  6. Incidence of treatment-emergent Adverse Events

    Time frame: Up to week 36

  7. Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)

    Time frame: week 1, week 12, week 24, week 36

    Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
Aug 3, 2022

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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