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
RECRUITING
Berlin
Orthopädie am Kiesteich
RECRUITING
Berlin
Orthopädie Dr. Bentzin
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