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| Name | Class |
|---|---|
| Clinical Study Centers, LLC | OTHER |
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This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBS 2 Resorb Mg | Experimental | Study arm treated with the HBS 2 Resorb Mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with HBS 2 Resorb Mg | Device | Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bony Fusion (Change) | The primary endpoint of the study is the fusion rate of the bone. After the onset of bony fusion, the implant no longer fulfils any function, and it should be resorbed. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary displacement and breakage of the implant (YES/NO) | Any secondary radiographic displacement or breakage of the implant or any clinically significant loss of reduction is noted. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Deep infection(YES/NO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Serafeim Tsitsilonis, PD Dr. | Contact | +49 30 450 652 127 | serafeim.tsitsilonis@charite.de | |
| Heilwig Fischer, Dr. | Contact | +49 30 450 655049 | heilwig.fischer@charite.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum für Muskuloskeletale Chirurgie (CMSC) | Recruiting | Berlin | 13353 | Germany |
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The presence of deep infections is assessed binary. |
| 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Clinical outcome | Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Surgical revisions(YES/NO) | As typically one single surgery should be sufficient to treat the patient, all secondary surgical interventions are revisions due to a complication. This includes also re-operation due to screw removal. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Early corrosion phenomenon(YES/NO) | Symptomatic gas accumulation or formation of gas pockets due to degradation of the material. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| Radiolucency(YES/NO) | Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon. | 6 weeks, 12 weeks, 6 month and 12 month after surgery |
| ID | Term |
|---|---|
| D057072 | Intra-Articular Fractures |
| D011542 | Pseudarthrosis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D005599 | Fractures, Ununited |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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