Clinical trial NCT06681051: Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Official title: Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tendinopathy
Keywords: tendinopathy
hyaluronan
tendon
hyaluronic acid
Lead sponsor: TRB Chemedica AG
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 when used according to the instructions for use.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
  * 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)

Primary outcomes:
measure: Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
timeFrame: Baseline compared to week 12 after the end of treatment.
Secondary outcomes:
measure: Change of Upper -/ Lower Extremity Functional Scale compared to baseline
timeFrame: Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment.
measure: Change of pain intensity compared to baseline (visual analogue scale)
timeFrame: Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.
measure: Change of patient-reported outcome measures (PROM)
timeFrame: Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
measure: Change of investigator-reported outcome measures
timeFrame: Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
measure: Degree of tendinopathy
timeFrame: Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment
measure: Incidence of Adverse Events with (possible/probable) causal relationship with the device or application procedure
timeFrame: Up to week 24 after the end of treatment.
measure: Incidence of Serious Adverse Events with (possible/probable) causal relationship with the device or application procedure
timeFrame: Up to week 24 after the end of treatment.
measure: Incidence of (Presumably) serious incidents
timeFrame: Up to week 24 after the end of treatment.
measure: Incidence of Device Deficiencies
timeFrame: Up to week 24 after the end of treatment.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: ATOS MVZ meviva Berlin
city: Berlin
country: Germany
facility: Orthopädie am Kiesteich
city: Berlin
country: Germany
facility: Orthopädie Dr. Bentzin
city: Potsdam
country: Germany
facility: Orthopädische Praxis Dr. Fischer
Study officials:
affiliation: Orthopädie am Kiesteich
name: Olaf Neubert, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: