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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostenil® | 3-5 injections of sodium hyaluronate 1 % (20 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostenil® | Device | Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252 |
| 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. | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168 |
| 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. | Day 84, Day 168 |
| 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). | Day 7, Day 14, Day 21, Day 28, Day 84, Day 168, Day 252 |
| Incidence of Treatment-Emergent Adverse Events | Up to Day 252 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 18 with Gonarthrosis and a Recommendation for Treatment with Ostenil®.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Krüger-Franke, Dr. med. | MVZ am Nordbad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädisches Versorgungszentrum München-Ost | Munich | Bavaria | 81825 | Germany | ||
| Orthopädie am Altheimer Eck |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| D012216 |
| Rheumatic Diseases |