RecruitingNot Applicable

Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders

Germany84 participantsStarted 2024-11-25

Plain-language summary

PMCF study to further substantiate the effectiveness and safety of OSTENIL® TENDON in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient aged between 18 and 99 years * Diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band) * Physician's recommendation to use OSTENIL® TENDON prior to recruitment * Signed informed consent Exclusion Criteria: * Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e., * Ascertained hypersensitivity to any of the OSTENIL® TENDON constituents * Known pregnancy or breast feeding * Acute trauma * Use of the following treatments (the given time intervals refer to the date of inclusion): * Local\* OSTENIL® TENDON or other hyaluronic acid (HA) treatment within the last 6 months * Local\* platelet-rich plasma (PRP) treatment within the last 3 months * Local\* corticosteroid treatment (without time restriction) * Local\* extracorporeal shock wave therapy (ESWT) within the last 4 weeks * Local\* phytotherapy (e.g., Traumeel®) within the last 4 weeks * Local\* surgical intervention (without time restriction) * Systemic corticosteroid treatment within the last 4 weeks * Repeated use of non-steroidal anti-inflammatory drugs (NSAID) and/or other analgesics within the last week * Physiotherapy (therapeutic exercises and physical therapy), ortheses, transcutaneous electrical nerve stimulation (TENS) or acupuncture within the last week * Diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, Bechterew disease, Crohn's…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)

Timeframe: Baseline compared to week 12 after the end of treatment.

Trial details

NCT IDNCT06681051

SponsorTRB Chemedica AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

Raphaela Geiger

+49 89-461483-27 geiger@trbchemedica.de

View on ClinicalTrials.gov More Tendinopathy trials