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Continuous Passive Motion Versus Heterotopic Ossification

Continuous Passive Motion Versus Heterotopic Ossification

Recruiting
15-70 years
All
Phase N/A

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Overview

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.

Description

The aim of this study is to formally evaluate whether the investigators can indeed prevent HO by the timely and painless use of CPM in neurogenic intensive care unit (ICU) patients with stabilized medical conditions, suffering from neurological insults either traumatic brain injury (TBI), stroke, or Spinal Cord Injury (SCI). The investigators hypothesize that HO formation can be suppressed if CPM can be performed for a substantial amount of time. The investigators will perform 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 primary outcomes will be the CT appearance of HO in the hip or knee joint and the degree of ROM limitation in the given joint at baseline and at the end of the clinical trial. A secondary outcome that will be measured, will be the Glasgow Coma Scale (GCS) at the beginning and at the end of the CPM program. The comparison between the treatment and referent groups in terms of these outcomes will prove the prophylactic power of CPM against HO.

Eligibility

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

Study details
    Traumatic Brain Injury
    Spinal Cord Injuries
    Stroke

NCT05906056

University of Ioannina

27 January 2024

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