Using OSTENIL® TENDON to treat pain and mobility issues in tendon disorders
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
This study is testing if OSTENIL® TENDON can help people with tendon pain and mobility issues feel better in everyday life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | TRB Chemedica AG Industry-sponsored |
| Locations | 5 sites (Berlin, State of Berlin and 4 other locations) |
| Trial ID | NCT06681051 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 diagnosed with symptomatic tendinopathy in specified tendon areas.
Not a fit: Patients with contraindications to OSTENIL® TENDON or those who have recently undergone specific treatments for their tendon issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and improve mobility for patients suffering from tendon disorders.
How similar studies have performed: While this approach is being evaluated in this specific context, similar treatments using hyaluronic acid have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Berlin, State of Berlin and 4 other locations
- Orthopädische Gemeinschaftspraxis ÜBAG — Berlin, State of Berlin, Germany (Recruiting)
- ATOS MVZ meviva Berlin — Berlin, Germany (Recruiting)
- Orthopädie am Kiesteich — Berlin, Germany (Recruiting)
- Orthopädie Dr. Bentzin — Berlin, Germany (Recruiting)
- Orthopädische Praxis Dr. Fischer — Potsdam, Germany (Recruiting)
Study contacts
- Principal investigator: Olaf Neubert, Dr. med. — Orthopädie am Kiesteich
- Study coordinator: Raphaela Geiger
- Email: geiger@trbchemedica.de
- Phone: +49 89-461483-27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.