Gonarthrosis
Conditions
Brief 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.
Interventions
DEVICEOstenil®
Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.
Sponsors
TRB Chemedica AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Pain Intensity compared to Baseline (VAS-slider) | 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) | 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 | 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) | 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 | Up to Day 252 | — |
Countries
Germany
Outcome results
None listed