Heterotopic OssificationPOHER IINCT04934332
Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma
A study testing Ultrasound, CT scan and Clinical examination in people with Heterotopic Ossification, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure. The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heterotopic Ossification
- What is being tested?
- Ultrasound, CT scan and Clinical examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to Jan 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ⩾ 18 years;
- Admitted to a neurological post intensive care rehabilitation unit for the first time;
- Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale < 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU);
- Patient's written consent obtained (or from an authorized relative);
- Affiliation to a social security scheme.
Who cannot join
- History of moderate or severe traumatic brain injury;
- History of spinal cord injury (para- or tetraplegia);
- History of stroke or disabling neurological disease;
- History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;
- Breast-feeding or pregnancy;
- Under court protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garche, 92380
About this study
Official title: Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.
The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.
The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.
Read the detailed description
Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO.
Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.
- Conditions
- Heterotopic Ossification
- Being tested
- Ultrasound, CT scan, Clinical examination
- Keywords
- heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound examination at 1 week and 5 weeks after admission.
CT scanProcedure or surgery
CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.
Clinical examinationProcedure or surgery
Weekly clinical examination from week-2 to week-5.
| Study group | Role | What they receive |
|---|---|---|
| Newly hospitalized patients | Experimental | Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma. Receives: Procedure: Ultrasound; Procedure: CT scan; Procedure: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC (receiver operating characteristic) curve at 1 week
Area under the ROC curve of ultrasound examination at 1 week compared CT scan at 5 weeks for making the diagnosis of HO.
Measured: at 1 week
Secondary outcomes (6)
Sensitivity
Sensitivity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.
Measured: at 1 week
Specificity
Specificity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.
Measured: at 1 week
Positive predictive value and negative predictive value
Positive predictive value and negative predictive value of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.
Measured: at 1 week
Likelihood-ratio of ultrasound
Likelihood-ratio of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.
Measured: at 1 week
Area under the ROC curve at 5 weeks
Area under the ROC curve of ultrasound examination at 5 weeks compared with CT scan at 5 weeks for making the diagnosis of HO.
Measured: at 5 weeks
Clinical examination
Area under the ROC curve of clinical examination at 1, 2, 3, 4, 5 weeks of admission compared with CT scan at 5 weeks to screen HO.
Measured: weekly from week-1 to week-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Mar 2022
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterotopic OssificationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Responsible party
- Sponsor
- Investigators
- Julie PAQUEREAU, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, FranceVincent T. CARPENTIER, MD, Study director, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934332
- Sponsor's protocol ID
- APHP210785
- Other IDs
- IDRCB 2021-A01096-35
- Acronym
- POHER II
- Status last verified
- Mar 2023
- First submitted
- 14 Jun 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit
- ClinicalTrials.gov ID
- NCT04934332
- Acronym / sponsor ID
- POHER II / APHP210785
- Conditions
- Heterotopic Ossification
- Keywords
- heterotopic ossification, post intensive care rehabilitation unit, early screening, ultrasound, neurological trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 22 Jun 2021 (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.
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.
The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.
The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.
Detailed description
Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO.
Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly hospitalized patients | Experimental | Procedure: Ultrasound, Procedure: CT scan, Procedure: Clinical examinationPatients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ⩾ 18 years;
- Admitted to a neurological post intensive care rehabilitation unit for the first time;
- Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale < 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU);
- Patient's written consent obtained (or from an authorized relative);
- Affiliation to a social security scheme.
Key exclusion criteria (6 listed)
- History of moderate or severe traumatic brain injury;
- History of spinal cord injury (para- or tetraplegia);
- History of stroke or disabling neurological disease;
- History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;
- Breast-feeding or pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound examination at 1 week and 5 weeks after admission. | Procedure or surgery | Newly hospitalized patients |
| CT scanCT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data. | Procedure or surgery | Newly hospitalized patients |
| Clinical examinationWeekly clinical examination from week-2 to week-5. | Procedure or surgery | Newly hospitalized patients |
Primary outcome
Area under the ROC (receiver operating characteristic) curve at 1 week
Time frame: at 1 week
Area under the ROC curve of ultrasound examination at 1 week compared CT scan at 5 weeks for making the diagnosis of HO.
6 secondary outcomes
Sensitivity
Time frame: at 1 week
Specificity
Time frame: at 1 week
Positive predictive value and negative predictive value
Time frame: at 1 week
Likelihood-ratio of ultrasound
Time frame: at 1 week
Area under the ROC curve at 5 weeks
Time frame: at 5 weeks
Clinical examination
Time frame: weekly from week-1 to week-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Julie PAQUEREAU, MD principal investigator
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
Vincent T. CARPENTIER, MD study director
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, CT scan and Clinical examination in people with Heterotopic Ossification, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie PAQUEREAU, MD (+33 1 47 10 70 82, julie.paquereau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the ROC (receiver operating characteristic) curve at 1 week (time frame: at 1 week). 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 17 Mar 2023.