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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757051
• Other study ID #: BEN-PMCF-DE-2020
• Status: Completed
• Start date: March 11, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: August 2022
• Source: TRB Chemedica AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Germany	Praxiszentrum Elisengalerie	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline	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	week 1, week 12, week 24, week 36
Primary	Change of pain intensity compared to baseline (visual analogue scale, VAS)	Evaluation of pain intensity by the patient on a 10 cm VAS-slider. 10 cm equals the worst pain.	week 1, week 12, week 24, week 36
Primary	Change of patient's global assessment (overall impression of clinical OA severity on a numerical rating scale from 0 to 10)	The change of overall subjective symptom severity evaluation on a scale from 0 (very good condition) to 10 (very poor condition).	week 1, week 12, week 24, week 36
Primary	Change of clinical global impression (overall impression of clinical OA severity of the investigator on a numerical rating scale from 0 to 10)	The change of clinical global Impression on a scale from 0 (very good condition) to 10 (very poor condition).	week 1, week 12, week 24, week 36
Primary	Responder rate according to OMERACT-OARSI criteria		week 24
Primary	Incidence of treatment-emergent Adverse Events		Up to week 36
Primary	Satisfaction scale (subjective satisfaction of patient and investigator with the treatment on a 5 Point likert scale)	Subjective satisfaction on a scale from 1 (very satisfied) to 5 (very unsatisfied)	week 1, week 12, week 24, week 36