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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03914521
Collaborator
(none)
40
1
18.1
2.2

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual 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 :
    Mar 1, 2019
    Actual Primary Completion Date :
    Mar 1, 2020
    Actual Study Completion Date :
    Sep 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. femoral head bone mineral density [1 year]

      femoral head bone mineral density

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Florence BAUMANN, MD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03914521
    Other Study ID Numbers:
    • RECHMPL19_0095
    First Posted:
    Apr 16, 2019
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier

    Study Results

    No Results Posted as of Dec 29, 2020