Using OSTENIL® TENDON to treat pain and mobility issues in tendon disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness and safety of OSTENIL® TENDON in treating pain and restricted mobility associated with various tendon disorders, including those affecting the patella tendon, peroneal tendon, medial epicondylus humeri, and iliotibial band. Patients aged 18 to 99 years with symptomatic tendinopathy will receive OSTENIL® TENDON as recommended by their physician. The study will be conducted in real-life clinical settings to gather data on its performance and safety when used according to the manufacturer's instructions.

Why it matters

Who can join: the full rules

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 disease, etc.) prior to inclusion
* Participation in a clinical investigation within the last 6 months
* Vulnerable patient (individual who is 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 \[including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language\])

(\* local refers to the treatment of the study-relevant tendon)

Where it's running

• Orthopädisches Versorgungszentrum und Interdisziplinäres Schmerzzentrum Zehlendorf
  Berlin, State of Berlin, Germany Recruiting
• Orthopädische Gemeinschaftspraxis ÜBAG
  Berlin, State of Berlin, Germany Completed
• ATOS MVZ meviva Berlin
  Berlin, Germany Completed
• Orthopädie am Kiesteich
  Berlin, Germany Completed
• Gemeinschaftspraxis Dr. Bierke
  Berlin, Germany Completed
• Orthopädische Praxis Dr. Fischer
  Potsdam, Germany Completed

Study contacts

• Principal investigator: Olaf Neubert, Dr. med. — Orthopädie am Kiesteich
• Study coordinator: Raphaela Geiger
• Email: geiger@trbchemedica.de
• Phone: +49 89-461483-27

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using advanced ultrasound to track blood flow in healthy and injured tendons

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.