ParaosteoarthropathiesNCT03914521
Pre-surgical CT Scan Assessment of Bone Mineral Density Before Resection of NHO of the Hip
An observational study of Paraosteoarthropathies, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraosteoarthropathies
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Minor patients
- Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
- Pre-surgery CT-scan and surgery report not available
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip
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.
Read more
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.
- Conditions
- Paraosteoarthropathies
- Keywords
- hip surgery, bone mineral density, femoral head, Pre-surgical prognostic
What is being measured
The primary outcome is the main question the study is designed to answer.
femoral head bone mineral density
femoral head bone mineral density
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParaosteoarthropathiesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BAUMANN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914521
- Sponsor's protocol ID
- RECHMPL19_0095
- Status last verified
- Dec 2020
- First submitted
- 11 Apr 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-surgical CT Scan Assessment of Femoral Head Bone Mineral Density Before Resection of Neurogenic Heterotopic Ossification (NHO) of the Hip
- ClinicalTrials.gov ID
- NCT03914521
- Acronym / sponsor ID
- RECHMPL19_0095
- Conditions
- Paraosteoarthropathies
- Keywords
- hip surgery, bone mineral density, femoral head, Pre-surgical prognostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Minor patients
- Patients didn't have surgery surgery resection of Neurogenic heterotopic ossification of hip.
- Pre-surgery CT-scan and surgery report not available
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
femoral head bone mineral density
Time frame: 1 year
femoral head bone mineral density
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BAUMANN, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraosteoarthropathies, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
femoral head bone mineral density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.