Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
NCT ID: NCT06681051
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
84 participants
OBSERVATIONAL
2024-11-25
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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OSTENIL® TENDON
2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.
OSTENIL® TENDON
OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.
Interventions
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OSTENIL® TENDON
OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
99 Years
ALL
No
Sponsors
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TRB Chemedica AG
INDUSTRY
Responsible Party
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Principal Investigators
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Olaf Neubert, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Orthopädie am Kiesteich
Locations
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Orthopädische Gemeinschaftspraxis ÜBAG
Berlin, State of Berlin, Germany
ATOS MVZ meviva Berlin
Berlin, , Germany
Orthopädie am Kiesteich
Berlin, , Germany
Orthopädie Dr. Bentzin
Berlin, , Germany
Orthopädische Praxis Dr. Fischer
Potsdam, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OTIPPE-PMCF-DE-2021
Identifier Type: -
Identifier Source: org_study_id
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