An observational study in Tendinopathy, sponsored by TRB Chemedica AG. Recruiting at 6 sites in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by TRB Chemedica AG · Observational
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.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's planned enrollment of 84 is above the median of 61 across 50 observational studies indexed under Tendinopathy.
Browse Tendinopathy studies →TRB Chemedica AG is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 years of age with symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band) and a recommendation for OSTENIL® TENDON treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of any or precautionary condition listed in the instructions for use, i.e.,
Use of the following treatments (the given time intervals refer to the date of inclusion):
(* local refers to the treatment of the study-relevant tendon)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.
Device: OSTENIL® TENDON
OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
Time frame: Baseline compared to week 12 after the end of treatment.
Change of Upper -/ Lower Extremity Functional Scale compared to baseline
Indication specific patient questionnaire to assess effectiveness of treatment on a 5-point Likert scale (range: 0 = extreme difficulty to perform activity to 4 = no difficulty).
Time frame: Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment.
Change of pain intensity compared to baseline (visual analogue scale)
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
Time frame: Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.
Change of patient-reported outcome measures (PROM)
Patient questionnaire to assess the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): pain, global and tendon-associated quality of life, daily activities, clinical global impression, mobility and satisfaction with treatment (note: not assessed at baseline)
Time frame: Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
Change of investigator-reported outcome measures
Investigator inquiry to record the perception of the physician of the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): clinical global impression regarding the clinical severity of the tendinopathy and satisfaction with the treatment (note: not assessed at baseline)
Time frame: Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
Degree of tendinopathy
Evaluation of tendinopathy symptoms by the patient by rating tendon pain in the context of a patient-defined task that usually elicits pain (4 stages; 4 equals a worse outcome)
Time frame: Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment
Incidence of Adverse Events with (possible/probable) causal relationship with the device or application procedure
Time frame: Up to week 24 after the end of treatment.
Incidence of Serious Adverse Events with (possible/probable) causal relationship with the device or application procedure
Time frame: Up to week 24 after the end of treatment.
Incidence of (Presumably) serious incidents
Time frame: Up to week 24 after the end of treatment.
Incidence of Device Deficiencies
Time frame: Up to week 24 after the end of treatment.
Not enrolling at this site.
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Plan to share: No — Proprietary company data will not be shared externally.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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TRB Chemedica AG