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

TRB Chemedica

Status

Enrolling

Conditions

Tendinopathy

Treatments

Device: OSTENIL® TENDON

Study type

Observational

Funder types

Industry

Identifiers

NCT06681051

OTIPPE-PMCF-DE-2021

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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])