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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-9206 | Other Identifier | WHO |
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This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chart review |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug | A review of retrospectively longitudinal data gathered in the routine follow-up from a subset of patients who underwent EOS in studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391). Data will be compiled, analysed, and reported in aggregate form. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term changes in general mobility/ambulation/activity | From pre-operative (baseline) functional status and up to at least 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term changes in work/school attendance | From pre-operative (baseline) functional status and up to at least 5 years | |
| Long-term changes in employment status | From pre-operative (baseline) functional status and up to at least 5 years |
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Inclusion Criteria:
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Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Princeton | New Jersey | 08540 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Long-term changes in body mass index (BMI) | From pre-operative (baseline) functional status and up to at least 5 years |
| Long-term changes in complications related to surgical procedure and/or prostheses | From pre-operative (baseline) functional status and up to at least 5 years |
| Overall frequency of bleeding episodes | From pre-operative (baseline) functional status and up to at least 5 years |
| Number of joint infections | From pre-operative (baseline) functional status and up to at least 5 years |
| Number of treatment types (on demand, prophylaxis) | From pre-operative (baseline) functional status and up to at least 5 years |
| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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