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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01830712
First received: April 10, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: eptacog alfa (activated)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Long-term changes in general mobility/ambulation/activity [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term changes in work/school attendance [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Long-term changes in employment status [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Long-term changes in body mass index (BMI) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall frequency of bleeding episodes [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Number of joint infections [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Number of treatment types (on demand, prophylaxis) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

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).

Criteria

Inclusion Criteria:

  • Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01830712

Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01830712     History of Changes
Other Study ID Numbers: F7HAEM-3864, U1111-1114-9206
Study First Received: April 10, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014