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

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ClinicalTrials.gov Identifier: NCT01830712
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date April 10, 2013
First Posted Date April 12, 2013
Last Update Posted Date April 15, 2014
Study Start Date April 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2013)
Long-term changes in general mobility/ambulation/activity [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01830712 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 10, 2013)
  • Long-term changes in work/school attendance [ Time Frame: 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 ]
  • Long-term changes in body mass index (BMI) [ Time Frame: 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 ]
  • Overall frequency of bleeding episodes [ Time Frame: 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 ]
  • Number of treatment types (on demand, prophylaxis) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors
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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
Intervention 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.
Study Groups/Cohorts Chart review
Intervention: Drug: eptacog alfa (activated)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2013)
15
Original Actual Enrollment Same as current
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01830712
Other Study ID Numbers F7HAEM-3864
U1111-1114-9206 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date April 2014