A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors

Study Overview
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Brief Summary
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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.

Official Title
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A Long-Term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors. A Retrospective Follow-up Assessment to F7HAEM/USA/3/USA and F7HAEM/USA/4/USA

Conditions
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Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Intervention / Treatment
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* Drug: eptacog alfa (activated)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chart review<br> | Drug: eptacog alfa (activated)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |