Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9)
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ClinicalTrials.gov Identifier: NCT01433536 |
Recruitment Status
:
Terminated
(Guillaume Grenier, principal investigator is no longer working at the lab. The lab is now closed.)
First Posted
: September 14, 2011
Last Update Posted
: January 24, 2018
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Bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster than in other patients. However, such patients are also occasionally prone to bone formation in soft tissues such as muscle. This process is called heterotopic ossification and tends to occur around joints. Patients with heterotopic ossification often suffer from complications such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. Loss of movement can also interfere with function and the quality of life of patients already experiencing difficulties associated with their trauma. Positioning, transfers, and hygiene become difficult and even impossible, which worsens the loss of autonomy.
Previous research has suggested that an osteoinductive factor (which has the capacity to induce the formation of bone) may be released into the bloodstream following a head or spinal cord injury. The investigators laboratory has shown that a growth factor called BMP-9, when injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged muscle. The investigators would like to find out whether the levels of BMP-9 and/or its receptor (which is called ALK1) increase after traumatic brain and spinal cord injuries that occur at the same time as serious orthopaedic traumas.
The main goal of the investigators study is thus to determine whether BMP-9 levels increase in the serum of trauma patients.
Condition or disease |
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Healthy High Velocity Fracture Cranial Trauma Spinal Trauma |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Evaluation of Circulating Osteogenic Factors in Trauma Patients (BMP-9) |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | December 1, 2017 |
Actual Study Completion Date : | December 1, 2017 |

Group/Cohort |
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cranial trauma and fracture
Individuals presenting a cranial trauma that are classified at equal to or less than 8 on the Glasgow scale, combined with a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
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cranial trauma
Individuals presenting a cranial trauma that are classified at equal to or less than 8 on the Glasgow scale
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spinal trauma with fracture
Individuals presenting a spinal fracture that are classified with an ASIA score of A, B, or C, combined with a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
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spinal trauma
Individuals presenting a spinal fracture that are classified with an ASIA score of A, B, or C
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high velocity fracture, inferior limb
Individuals that present a fracture to the femur, tibia, or pelvis resulting from a high-velocity impact
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Control
Healthy individuals
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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- cranial trauma with Glasgow =< 8
- spinal trauma with ASIA A, B, C
- high-velocity fracture of femur, tibia, pelvis
Exclusion Criteria:
- brain dead
- pathological fractures (cancer, osteoporosis)
- blood transfusion received
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433536
Canada, Quebec | |
Centre Hospitalier Universitaire de Sherbrooke | |
Sherbrooke, Quebec, Canada, J1H 5N4 |
Principal Investigator: | Guillaume Grenier, Ph.D. | Université de Sherbrooke |
Responsible Party: | Guillaume Grenier, Associate Professor, Université de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT01433536 History of Changes |
Other Study ID Numbers: |
10-100 MOP-115149 ( Other Grant/Funding Number: CIHR ) |
First Posted: | September 14, 2011 Key Record Dates |
Last Update Posted: | January 24, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Guillaume Grenier, Université de Sherbrooke:
cranial trauma with or without high velocity fracture to inferior limb spinal trauma with or without high velocity fracture to inferior limb high velocity fracture to inferior limb |
Additional relevant MeSH terms:
Wounds and Injuries |