TendinopathyNCT06681051
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
An observational study of Tendinopathy, run by TRB Chemedica AG at 6 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- OSTENIL® TENDON
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 84 participants
- Where
- 6 sitesGermany
- Study dates
- 25 Nov 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e.,
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 1 recruiting
- Completed
Orthopädische Gemeinschaftspraxis ÜBAG
Berlin, State of Berlin, 14195
- Recruiting
Orthopädisches Versorgungszentrum und Interdisziplinäres Schmerzzentrum Zehlendorf
Berlin, State of Berlin, 14195
Christopher Kohler, Dr. med., +49 30 81051850, kohler@ortho-zentrum-zehlendorf.de
- Completed
ATOS MVZ meviva Berlin
Berlin, 10627
- Completed
Orthopädie am Kiesteich
Berlin, 13589
- Completed
Gemeinschaftspraxis Dr. Bierke
Berlin, 14197
- Completed
Orthopädische Praxis Dr. Fischer
Potsdam, 14482
About this study
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.
- Conditions
- Tendinopathy
- Being tested
- OSTENIL® TENDON
- Keywords
- tendinopathy, hyaluronan, tendon, hyaluronic acid
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSTENIL® TENDONDevice
OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.
| Study group | Role | What they receive |
|---|---|---|
| OSTENIL® TENDON | 2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. Receives: Device: OSTENIL® TENDON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline compared to week 12 after the end of treatment.
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to week 24 after the end of treatment.
Incidence of (Presumably) serious incidents
Measured: Up to week 24 after the end of treatment.
Incidence of Device Deficiencies
Measured: Up to week 24 after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start25 Nov 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRB Chemedica AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaf Neubert, Dr. med., Principal investigator, Orthopädie am Kiesteich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681051
- Sponsor's protocol ID
- OTIPPE-PMCF-DE-2021
- Status last verified
- Nov 2026
- First submitted
- 7 Nov 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Proprietary company data will not be shared externally.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
- ClinicalTrials.gov ID
- NCT06681051
- Acronym / sponsor ID
- OTIPPE-PMCF-DE-2021
- Conditions
- Tendinopathy
- Keywords
- tendinopathy, hyaluronan, tendon, hyaluronic acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- TRB Chemedica AGIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSTENIL® TENDON | – | Device: OSTENIL® TENDON2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Presence of any contra-indication 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):
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSTENIL® TENDONOSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation. | Device | OSTENIL® TENDON |
Primary outcome
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
Time frame: Baseline compared to week 12 after the end of treatment.
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
9 secondary outcomes
Change of Upper -/ Lower Extremity Functional Scale compared to baseline
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)
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)
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
Time frame: Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
Degree of tendinopathy
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Proprietary company data will not be shared externally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olaf Neubert, Dr. med. principal investigator
Orthopädie am Kiesteich
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinopathy, run by TRB Chemedica AG at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphaela Geiger (+49 89-461483-27, geiger@trbchemedica.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale) (time frame: Baseline compared to week 12 after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.