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

December 27, 2023 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chart review
Drug: eptacog 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Long-term changes in work/school attendance
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years
Long-term changes in employment status
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years
Long-term changes in body mass index (BMI)
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
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
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years
Overall frequency of bleeding episodes
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years
Number of joint infections
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years
Number of treatment types (on demand, prophylaxis)
Time Frame: From pre-operative (baseline) functional status and up to at least 5 years
From pre-operative (baseline) functional status and up to at least 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimated)

April 12, 2013

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-3864
  • U1111-1114-9206 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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