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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSTENIL® TENDON | 2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSTENIL® TENDON | Device | OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline compared to week 12 after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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])
(* local refers to the treatment of the study-relevant tendon)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaela Geiger | Contact | +49 89-461483-27 | geiger@trbchemedica.de | |
| Veronika Mussack, Dr. | Contact | +49 89-461483-43 | mussack@trbchemedica.de |
| Name | Affiliation | Role |
|---|---|---|
| Olaf Neubert, Dr. med. | Orthopädie am Kiesteich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Gemeinschaftspraxis ÜBAG | Recruiting | Berlin | State of Berlin | 14195 | Germany |
Proprietary company data will not be shared externally.
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| 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. |
| 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) | 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) | 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) | 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 | 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 | Up to week 24 after the end of treatment. |
| Incidence of (Presumably) serious incidents | Up to week 24 after the end of treatment. |
| Incidence of Device Deficiencies | Up to week 24 after the end of treatment. |
| ATOS MVZ meviva Berlin | Completed | Berlin | 10627 | Germany |
| Orthopädie am Kiesteich | Recruiting | Berlin | 13589 | Germany |
|
| Orthopädie Dr. Bentzin | Active, not recruiting | Berlin | 14197 | Germany |
| Orthopädische Praxis Dr. Fischer | Completed | Potsdam | 14482 | Germany |