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Completed

NCT Number: NCT01830712

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

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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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Long-term changes in general mobility/ambulation/activity

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

Secondary outcomes

  1. Long-term changes in work/school attendance

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  2. Long-term changes in employment status

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  3. Long-term changes in body mass index (BMI)

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  4. Long-term changes in complications related to surgical procedure and/or prostheses

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  5. Overall frequency of bleeding episodes

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  6. Number of joint infections

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

  7. Number of treatment types (on demand, prophylaxis)

    Time frame: From pre-operative (baseline) functional status and up to at least 5 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 12, 2013
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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