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Pre-surgical CT Scan Assessment of Bone Mineral Density Before Resection of NHO of the Hip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914521
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Neurogenic heterotopic ossification (NHO) is defined as an ectopic ossification around proximal joints usually seen after traumatic brain injury, spinal cord injury or polytrauma.

NHO causes pain, partial or total joint ankylosis and vascular or nerve complications.

The osteopenia (low bone density) induced by ankylose increases the fracture risk of femoral neck during the hip surgery performed to remove the NHO.

The analyse of femoral head bone mineral density from hip pre-surgical CT scan could anticipate this kind of complication establishing a presurgical prognostic.

If as it turns out the bone density measured from hip pre-surgical CT scan is relevant fracture risk marker, a preventive osteosynthesis or femoral head and neck resection could be performed in the same time of NHO resection.


Condition or disease
Paraosteoarthropathies

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. femoral head bone mineral density [ Time Frame: 1 year ]
    femoral head bone mineral density



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.

Their per-operative CT-scan and surgery report will be collected from the records of Nîmes and Montpellier University Hospital Center

Criteria

Inclusion Criteria:

  • Patients aged 18 years and over
  • Patients having surgery resection of surgery resection of Neurogenic heterotopic ossification of hip.
  • Patients with pre-surgery CT-scan and surgery report available

Exclusion criteria:

  • Minor patients
  • Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
  • Pre-surgery CT-scan and surgery report not available

Exclusion Criteria:

-


Information from the National Library of Medicine

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): NCT03914521


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Florence BAUMANN, MD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03914521    
Other Study ID Numbers: RECHMPL19_0095
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
hip surgery
bone mineral density
femoral head
Pre-surgical prognostic