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

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 Overview

• Status: Recruiting
• Conditions: Tendinopathy
• Intervention / Treatment: Device: OSTENIL® TENDON

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Raphaela Geiger; Phone Number: +49 89-461483-27; Email: geiger@trbchemedica.de
• Study Contact Backup: Name: Veronika Mussack, Dr.; Phone Number: +49 89-461483-43; Email: mussack@trbchemedica.de

Study Locations

• Germany
  • Berlin, Germany, 13589
    • Recruiting
    • Orthopädie am Kiesteich
    • Contact: Frederic Braun, Dr. med.; Phone Number: +49 30-585813900; Email: info@orthopaedie-am-kiesteich.de
    • Principal Investigator: Frederic Braun, Dr. med.
  • Berlin, Germany, 14197
    • Active, not recruiting
    • Orthopädie Dr. Bentzin
  • Berlin, Germany, 10627
    • Completed
    • ATOS MVZ meviva Berlin
  • Potsdam, Germany, 14482
    • Completed
    • Orthopädische Praxis Dr. Fischer
  • State of Berlin
    • Berlin, State of Berlin, Germany, 14195
      • Recruiting
      • Orthopädische Gemeinschaftspraxis ÜBAG
      • Contact: Frank Klufmöller, Dr. med.; Phone Number: +49 30 82007430; Email: frank@klufmoeller.de
      • Principal Investigator: Frank Klufmöller, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSTENIL® TENDON; 2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.	Device: OSTENIL® TENDON; OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Olaf Neubert, Dr. med., Orthopädie am Kiesteich

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: tendon; hyaluronic acid; tendinopathy; hyaluronan
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: OTIPPE-PMCF-DE-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Proprietary company data will not be shared externally.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No