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
2 other identifiers
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedDecember 29, 2023
December 1, 2023
4 months
April 10, 2013
December 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term changes in general mobility/ambulation/activity
From pre-operative (baseline) functional status and up to at least 5 years
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Chart review
Interventions
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 Criteria
Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).
You may qualify if:
- Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
April 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
December 29, 2023
Record last verified: 2023-12