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Continuous Passive Motion Versus Heterotopic Ossification

RecruitingNAAges 15 Years - 70 YearsAllUniversity of Ioannina
NCT05906056 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The comparison between the treatment and referent groups of the outcomes will prove the prophylactic power of CPM against HO.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury. 2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT) 3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.) 4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion. Exclusion Criteria: 1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult. 2. HO detected in another location than the hip or knee joint. 3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level. 4. Patients not reacting to painful stimuli
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What it tests

  • Continuous Passive Motion (CPM)
  • Conventional physiotherapy (PT)
  • Zoledronic Acid Injection
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Where

1 site
Department of Physical and Rehabilitation Medicine
Ioannina, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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