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The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid sodium salt (1%, 20mg/2ml) | Active Comparator |
| |
| Standard arthroscopic procedure | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostenil | Device | Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic. |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery. | Mayo wrist score evaluation consisting of 4 sections:
| Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment. | Measured during the 6-month duration of participation | |
| Disabilities of the arm, shoulder, and hand (DASH) outcome measure | Measured during the 6-month duration of participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Schütz, Dr. med. | Orthopädische Gemeinschaftspraxis, Straubing (Germany) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Gemeinschaftspraxis | Straubing | Bavaria | 94315 | Germany |
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|
| Standard arthroscopic procedure | Procedure | Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment. |
|
| Grip strength | Measured during the 6-month duration of participation |
| Visual analogue scale of pain (VAS; 100 mm) | Measured during the 6-month duration of participation |
| Clinical Global Impression (CGI) | Measured during the 6-month duration of participation |
| Inter-group comparison of Mayo wrist subscores in subjects with or without post-arthroscopic hyaluronan treatment. |
| Measured during the 6-month duration of participation |
| Number of subjects with Adverse Events as a measure of safety and tolerability | Measured during the 6-month duration of participation |