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Compares treatment options for Traumatic Brain Injury
Official title Continuous Passive Motion Versus Heterotopic Ossification
ClinicalTrials.gov ID: NCT05906056
What this study is testing
What is Zoledronic Acid Injection?
Zoledronic Acid Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators hypothesize that Heterotopic Ossification (HO) formation can be suppressed if the application of a Continuous Passive Motion (CPM) device can be performed for a substantial amount of time. The investigators will use the following study design: a pilot study with 10 ICU patients receiving CPM and 10 matched cases which will follow a conventional physiotherapy program at the time of the conduction of the study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 70
You may be able to join if
- Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
- A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
- A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
- Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.
You likely can't join if
- Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
- HO detected in another location than the hip or knee joint.
- Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
- Patients not reacting to painful stimuli
The study team makes the final eligibility decision.
Where it's taking place
- Ioannina, Epirus, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ioannina, Epirus, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.