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PMCF study to observe the Routine application of Ostenil® Plus in the Treatment of pain and restricted mobility in degenerative and traumatic changes of the Hip Joint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostenil® Plus | 1-3 injections of sodium hyaluronate 2% (40 milligrams (mg) / 2,0 millilitres (ml)) in weekly interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostenil® Plus | Device | Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % 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 most pain) | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| Change of Range of Motion compared to Baseline (Goniometer measurement) | Assessment of the Range of internal and exernal rotation of the Hip Joint using a Goniometer. | Day 7, Day 14, Day 84 after last injection, Day 168 after last injection |
| 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 84 after last injection, Day 168 after last injection |
| Incidence of Treatment-Emergent Adverse Events | Up to Day 252 after the last injection | |
| Change of Subjective Therapy Evaluation of Pain (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Pain on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Therapy Evaluation of Stiffness (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Stiffness on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Therapy Evaluation of Function in daily living (HOOS Questionnaire) compared to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with Coxarthrosis and a Recommendation for Treatment with Ostenil® Plus.
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| Name | Affiliation | Role |
|---|---|---|
| Knut Behle, Dr. med. | OrthopädieZentrum Maschen | Principal Investigator |
| Darja Becker, Dr. med. | Orthopädie Praxis Dr. Darja Becker | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Praxis Rahlstedt | Hamburg | Free and Hanseatic City of Hamburg | 22143 | Germany | ||
| Gemeinschaftspraxis für Orthopädie und Unfallchirurgie |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Function in daily living on a 5-point Likert scale |
| Day 84 after last injection, Day 168 after last injection |
| Change of Subjective Therapy Evaluation of Quality of Life (HOOS Questionnaire) compared to Baseline | Hip Disability and Osteoarthritis Outcome Score (HOOS) to assess Quality of Life on a 5-point Likert scale | Day 84 after last injection, Day 168 after last injection |
| Bad Oldesloe |
| Schleswig-Holstein |
| 23843 |
| Germany |
| Orthopraxis Kiel | Gettorf | Schleswig-Holstein | 24214 | Germany |
| Zentrum für Medizin des Bewegungsapparates | Heide | Schleswig-Holstein | 25746 | Germany |
| Orthopädische Gemeinschaftspraxis Eutin | Eutin | 23701 | Germany |
| Orthopädie Praxis | Ramelsloh | 21220 | Germany |
| OrthopädieZentrum Maschen | Seevetal | 21220 | Germany |
| D012216 |
| Rheumatic Diseases |