Routine Application of Ostenil® in Patients with Gonarthrosis

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.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädisches Versorgungszentrum München-Ost, Munich, Bavaria, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

Ostenil®

Device

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

Primary outcomes

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

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

Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. 10 cm equals the worst pain.
Change of Range of Motion compared to Baseline (Goniometer measurement)

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

Assessment of the Range of Extension and Flexion of the Knee Joint using a Goniometer.
Change of Subjective Therapy Evaluation (KOOS Questionnaire) compared to Baseline

Time frame: Day 84, Day 168

Knee injury and Osteoarthritis Outcome Score (KOOS) to assess Stiffness, Pain, Function (daily living) and Quality of Life on a 5-point Likert scale.
Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)

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

The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse).
Incidence of Treatment-Emergent Adverse Events

Time frame: Up to Day 252

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Nov 7, 2018
Registry last updated: Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed