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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01830712

Enrollment

Registered

2013-04-12

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGeptacog alfa (activated)

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

* Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)

Design outcomes

Primary

Measure	Time frame
Long-term changes in general mobility/ambulation/activity	From pre-operative (baseline) functional status and up to at least 5 years

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026