Knee OsteoarthritisNCT04757051
Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by TRB Chemedica AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2021to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: week 1, week 12, week 24, week 36
Responder rate according to OMERACT-OARSI criteria
Measured: week 24
Incidence of treatment-emergent Adverse Events
Measured: 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)
Measured: week 1, week 12, week 24, week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start11 Mar 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. med. Eichhorn, Principal investigator, Praxiszentrum Elisengalerie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757051
- Sponsor's protocol ID
- BEN-PMCF-DE-2020
- Status last verified
- Aug 2022
- First submitted
- 11 Feb 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38498142
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Use of BENART TM in Patients With Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04757051
- Acronym / sponsor ID
- BEN-PMCF-DE-2020
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between 18 and 99 years with knee osteoarthitis and a recommendation for treatment with BENART TM.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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).
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).
Responder rate according to OMERACT-OARSI criteria
Time frame: week 24
Incidence of treatment-emergent Adverse Events
Time frame: Up to week 36
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 38498142Lynen 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.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. med. Eichhorn principal investigator
Praxiszentrum Elisengalerie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by TRB Chemedica AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of subjective therapy evaluation (KOOS questionnaire) compared to baseline (time frame: week 1, week 12, week 24, week 36). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.