Actively Recruiting
Effectiveness and Safety of OSTENIL4 TENDON in Treating Pain and Limited Movement in Tendon Disorders
Led by TRB Chemedica AG · Updated on 2026-06-02
84
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of OSTENIL4 TENDON in treating pain and limited movement caused by four tendon disorders: patella tendon, peroneal tendon, medial epicondylus humeri, and iliotibial band. This study takes place in real-life clinical settings to gather evidence on the device's use according to its instructions. Participants receive two injections of OSTENIL4 TENDON, which contains 2% sodium hyaluronate, given one week apart. This CE-certified device is intended for injection around or inside the tendon sheath. The study focuses on monitoring patients after these injections. During the study, participants will have their pain levels measured at the start and 12 weeks after treatment using a visual scale. Additional checks include functional ability, patient and investigator reports, and tendon condition at various points over 24 weeks. Safety will be closely tracked by recording any adverse events or device issues throughout the follow-up period, which lasts up to 24 weeks after treatment.
CONDITIONS
Brief Title
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged between 18 and 99 years
- Diagnosis of symptomatic tendinopathy affecting patella tendon, peroneal tendon, medial epicondylus humeri, or iliotibial band
- Physician has recommended OSTENIL4 TENDON before joining the study
- Signed informed consent provided
You will not qualify if you...
- Known allergy to any ingredients of OSTENIL4 TENDON
- Pregnant or breastfeeding women
- Acute trauma at the affected tendon
- Local OSTENIL4 TENDON or other hyaluronic acid treatment within last 6 months
- Local platelet-rich plasma treatment within last 3 months
- Local corticosteroid treatment at any time
- Local extracorporeal shock wave therapy within last 4 weeks
- Local phytotherapy (e.g., Traume e) within last 4 weeks
- Local surgical intervention at any time
- Systemic corticosteroid treatment within last 4 weeks
- Repeated use of NSAIDs or other painkillers within last week
- Physiotherapy, ortheses, TENS, or acupuncture within last week
- Chronic inflammatory diseases such as rheumatoid arthritis, Bechterew disease, or Crohn's disease
- Participation in another clinical trial within last 6 months
- Vulnerable individuals unable to fully understand study participation or who may be unduly influenced
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive 2 injections of OSTENIL® TENDON, a viscoelastic solution, administered one week apart.
2 visits (in-person) one week apart
Duration - 24 weeks
Participants are monitored for changes in pain, functional scales, and safety outcomes up to 24 weeks after receiving the treatment.
Visits at week 1, and weeks 4, 12, and 24 after treatment
Trial Site Locations
Total: 5 locations
1
Orthopädische Gemeinschaftspraxis ÜBAG
Berlin, State of Berlin, Germany, 14195
Actively Recruiting
2
ATOS MVZ meviva Berlin
Berlin, Germany, 10627
Active, Not Recruiting
3
Orthopädie am Kiesteich
Berlin, Germany, 13589
Actively Recruiting
4
Orthopädie Dr. Bentzin
Berlin, Germany, 14197
Active, Not Recruiting
5
Orthopädische Praxis Dr. Fischer
Potsdam, Germany, 14482
Actively Recruiting
Research Team
R
Raphaela Geiger
V
Veronika Mussack, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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