Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06681051
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06681051
Study Brief:
Protocol Section:
NCT06681051