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

NCT04757051 | Completed DMC

• 1 other identifier: BEN-PMCF-DE-2020
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• Responder rate according to OMERACT-OARSI criteria

  week 24

• Incidence of treatment-emergent Adverse Events

  Up to week 36

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (1)

Praxiszentrum Elisengalerie

Aachen, 52062, Germany

Location

Related Publications (1)

• Lynen NA, Eichhorn C, Portelange N, Chausson M, Weyenberg W. Long-Term Efficacy Following Intra-articular Injection of Carboxymethyl-chitosan, a New Product Class for Knee Osteoarthritis: Results from an Observational Study in Germany. Rheumatol Ther. 2024 Jun;11(3):649-662. doi: 10.1007/s40744-024-00661-6. Epub 2024 Mar 18.

  PMID: 38498142 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dr. med. Eichhorn

  Praxiszentrum Elisengalerie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: March 11, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)