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CompletedNCT03734315Updated Oct 9, 2024

Routine Application of Ostenil® in Patients with Gonarthrosis

An observational study in Gonarthrosis, sponsored by TRB Chemedica AG. Completed at 6 sites in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by TRB Chemedica AG · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
115
Ages
18 Years to 99 Years
Sex
All
01

Study summary

PMCF study to observe the routine application of Ostenil® in the treatment of pain and restricted mobility in degenerative and traumatic changes of the knee joint.

02

Conditions studied

  • Gonarthrosis
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 115 is above the median of 100 across 484 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

TRB Chemedica AG is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects ≥ 18 years of age and in good general health condition
  • Signed informed consent
  • Existing Ostenil® recommendation for the treatment of gonarthrosis

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to one of the Ostenil® components
  • Presence of articular effusion in study-relevant knee joint
  • Known pregnancy or lactating females
  • Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
  • Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and cohorts

  • Ostenil®

    3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.

    Device: Ostenil®

Interventions

  • DeviceOstenil®

    Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.

06

What researchers measure

Primary outcomes

  1. Change of Pain Intensity compared to Baseline (VAS-slider)

    Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain.

    Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252

  2. Change of Range of Motion compared to Baseline (Goniometer measurement)

    Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.

    Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168

  3. Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline

    Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.

    Time frame: Day 84, Day 168

  4. Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)

    The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).

    Time frame: Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to Day 252

07

Study locations

6 sites
  • Orthopädisches Versorgungszentrum München-Ost
    Munich, Bavaria 81825, Germany
  • Orthopädie am Altheimer Eck
    München, Bavaria 80331, Germany
  • Orthopädie München
    München, Bavaria 80331, Germany
  • Orthopädische Praxis am Isartor
    München, Bavaria 80331, Germany
  • MVZ am Nordbad
    München, Bavaria 80797, Germany
  • Orthopädische Praxis
    München, Bavaria 80993, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jan 2023, 48 months.

Of 42 industry-sponsored observational studies under Osteoarthritis, Knee, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 165. This study's 48 months is close to that.

Counting every sponsor, half of 215 studies reached it within 25 months; a quarter within 13 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2018
First posted
Nov 7, 2018
StartActual
Jan 8, 2019
Primary completionActual
Jan 12, 2023
CompletionActual
Jan 12, 2023
Last update
Oct 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03734315
Lead sponsor
TRB Chemedica AG
Responsible party
Sponsor
First posted
Nov 7, 2018
Start date
Jan 8, 2019
Primary completion
Jan 12, 2023
Completion
Jan 12, 2023
Last update
Oct 9, 2024

Study contacts

Michael Krüger-Franke, Dr. med.
principal investigator · MVZ am Nordbad

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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