NCT00824798

Brief Summary

Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability and mobility, axial deviation, deterioration and decreased function are the most frequent complains in patients with severe haemophilic arthropathy In this context, the purpose of our study is to examine and analyse specific changes in gait in patients suffering from haemophilic arthropathy and determine the impact on health-related quality of life in terms of conceptual components of pain and stiffness, psychosocial stress, disability, and activity limitations as recommended by the International Classification of Function (ICF) recently published by the World Health Organization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

January 16, 2009

Last Update Submit

July 10, 2019

Conditions

Hemophilia AHemophilia B

Keywords

gaithaemophiliaarthropathy

Outcome Measures

Primary Outcomes (1)

  • evaluate specific changes in gait in patients suffering from haemophilic arthropathy

    from inclusion in the study until 1 year after inclusion

Study Arms (1)

haemophiliacs A and B

haemophiliacs A and B mild, moderate or severe from 4 to 80 years old, with or without inhibitors.

Eligibility Criteria

Age5 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

haemophilia A or B, mild, moderate or severe.

You may qualify if:

  • haemophilia A or B
  • aged more than 4 years

You may not qualify if:

  • impossibility to walk on a treadmill
  • recent joint haemarthrosis or muscle haematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (5)

  • Lobet S, Detrembleur C, Francq B, Hermans C. Natural progression of blood-induced joint damage in patients with haemophilia: clinical relevance and reproducibility of three-dimensional gait analysis. Haemophilia. 2010 Sep 1;16(5):813-21. doi: 10.1111/j.1365-2516.2010.02245.x. Epub 2010 Apr 7.

    PMID: 20398067RESULT

  • Lobet S, Hermans C, Pasta G, Detrembleur C. Body structure versus body function in haemophilia: the case of haemophilic ankle arthropathy. Haemophilia. 2011 May;17(3):508-15. doi: 10.1111/j.1365-2516.2010.02433.x. Epub 2011 Mar 4.

    PMID: 21371180RESULT

  • Lobet S, Hermans C, Bastien GJ, Massaad F, Detrembleur C. Impact of ankle osteoarthritis on the energetics and mechanics of gait: the case of hemophilic arthropathy. Clin Biomech (Bristol). 2012 Jul;27(6):625-31. doi: 10.1016/j.clinbiomech.2012.01.009. Epub 2012 Feb 29.

    PMID: 22381586RESULT

  • Lobet S, Detrembleur C, Hermans C. Impact of multiple joint impairments on the energetics and mechanics of walking in patients with haemophilia. Haemophilia. 2013 Mar;19(2):e66-72. doi: 10.1111/hae.12001. Epub 2012 Sep 9.

    PMID: 22958138RESULT

  • Lobet S, Detrembleur C, Massaad F, Hermans C. Three-dimensional gait analysis can shed new light on walking in patients with haemophilia. ScientificWorldJournal. 2013 May 13;2013:284358. doi: 10.1155/2013/284358. Print 2013.

    PMID: 23766686RESULT

MeSH Terms

Conditions

Hemophilia AHemophilia BJoint Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-LinkedMusculoskeletal Diseases

Study Officials

  • sebastien lobet

    sebastien.lobet@uclouvain.be

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

BE(1)