Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders

ClinicalTrials.gov ID

NCT06681051

Lead Sponsor

TRB Chemedica AGINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

84Estimated

Last Update Posted

Aug 4, 2026Actual

Start Date

Nov 25, 2024Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

Official Title

Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders

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.

• Tendinopathy

• OSTENIL® TENDON

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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)

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

TRB Chemedica AGINDUSTRY

info@orthopaedie-am-kiesteich.de+49 30-585813900

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