Continuous Passive Motion Versus Heterotopic Ossification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-70
SponsorUniversity of Ioannina
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continuous Passive Motion (CPM)
- Conventional physiotherapy (PT)
- Zoledronic Acid Injection
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov