Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
ATOS MVZ meviva Berlin
ACTIVE_NOT_RECRUITING
Berlin
Orthopädie am Kiesteich
RECRUITING
Berlin
Orthopädie Dr. Bentzin
ACTIVE_NOT_RECRUITING
Berlin
Orthopädische Gemeinschaftspraxis ÜBAG
RECRUITING
Berlin
Orthopädische Praxis Dr. Fischer
RECRUITING
Potsdam
Contact Information
Primary
Raphaela Geiger
geiger@trbchemedica.de
+49 89-461483-27
Backup
Veronika Mussack, Dr.
mussack@trbchemedica.de
+49 89-461483-43
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2026-10
Participants
Target number of participants: 84
Treatments
OSTENIL® TENDON
2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.
Related Therapeutic Areas
Sponsors
Leads: TRB Chemedica AG