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

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT04757051
• Lead Sponsor: TRB Chemedica AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Study Start: 2021-03-11
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline	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
Change of pain intensity compared to baseline (visual analogue scale, VAS)	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.
Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)	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).
Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)	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).
Responder rate according to OMERACT-OARSI criteria	week 24
Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)	week 1, week 12, week 24, week 36	Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)
Incidence of treatment-emergent Adverse Events	Up to week 36

Trial Locations

Locations (1)

Praxiszentrum Elisengalerie; 🇩🇪 Aachen, Germany