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

Completed

• Conditions: Haemophilia A With Inhibitors; Haemophilia B With Inhibitors; Congenital Bleeding Disorder
• Interventions: Drug: eptacog alfa (activated)

• Registration Number: NCT01830712
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chart review	eptacog alfa (activated)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Long-term changes in employment status	From pre-operative (baseline) functional status and up to at least 5 years
Long-term changes in work/school attendance	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
Long-term changes in body mass index (BMI)	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

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Princeton, New Jersey, United States