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

Launched by TRB CHEMEDICA AG · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a treatment called OSTENIL® TENDON for patients suffering from pain and limited movement due to tendon disorders, specifically in the patella tendon, peroneal tendon, medial epicondylus humeri, and iliotibial band. The goal is to see how well this treatment works in real-life situations and whether it can help improve symptoms for people with these conditions.

To participate in the trial, you need to be between 18 and 99 years old and have a diagnosis of tendinopathy, which means you experience pain and issues with movement in the affected tendon. Your doctor must also recommend this treatment before you can join. If you meet these criteria, you can expect to receive the OSTENIL® TENDON treatment as part of the study, where your progress will be closely monitored. However, there are some reasons you might not be able to participate, such as recent treatments for your tendon issues or certain medical conditions. If you're interested in learning more, talk to your healthcare provider about whether this trial might be suitable for you.

Gender

ALL

Eligibility 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)