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

NCT06681051 | Recruiting

• 1 other identifier: OTIPPE-PMCF-DE-2021
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 5

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.

Conditions

Tendinopathy

Keywords

tendinopathy; hyaluronan; tendon; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (9)

• Change of Upper -/ Lower Extremity Functional Scale compared to baseline

  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)

  Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.

• Change of patient-reported outcome measures (PROM)

  Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.

• Change of investigator-reported outcome measures

  Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.

• Degree of tendinopathy

  Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment

Study Arms (1)

OSTENIL® TENDON

2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.

Device: OSTENIL® TENDON

Interventions

OSTENIL® TENDON DEVICE

OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.

OSTENIL® TENDON

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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 \[including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language\])

Sponsors & Collaborators

• TRB Chemedica AG: lead

Study Sites (5)

Orthopädische Gemeinschaftspraxis ÜBAG

Berlin, State of Berlin, 14195, Germany

RECRUITING

ATOS MVZ meviva Berlin

Berlin, 10627, Germany

RECRUITING

Orthopädie am Kiesteich

Berlin, 13589, Germany

RECRUITING

Orthopädie Dr. Bentzin

Berlin, 14197, Germany

RECRUITING

Orthopädische Praxis Dr. Fischer

Potsdam, 14482, Germany

RECRUITING

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Olaf Neubert, Dr. med.

  Orthopädie am Kiesteich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphaela Geiger

CONTACT

+49 89-461483-27; geiger@trbchemedica.de

Veronika Mussack, Dr.

CONTACT

+49 89-461483-43; mussack@trbchemedica.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)