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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2022-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of MEDI7352 in Painful Osteoarthritis of the Knee

NCT02508155

Chronic Pain

COMPLETED PHASE1

A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee

NCT04675034

Painful Osteoarthritis of the Knee

COMPLETED PHASE2

Routine Application of Ostenil® in Patients with Gonarthrosis

NCT03734315

Gonarthrosis

COMPLETED

A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

NCT02087904

Knee Osteoarthritis Medial Compartment Knee Osteoarthritis

COMPLETED PHASE2

A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

NCT01091116

Osteoarthritis, Knee

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No