Actively Recruiting
Continuous Passive Motion Versus Heterotopic Ossification
Led by University of Ioannina · Updated on 2024-12-06
20
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Passive Motion Versus Heterotopic Ossification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury
- Negative triplex ultrasound to rule out deep venous thrombosis (DVT)
- Positive three-phase bone scan with Tc99 upon onset of HO symptoms
- Verified HO formation on the knee or hip joint confirmed by CT scan
You will not qualify if you...
- Life-threatening conditions making Continuous Passive Motion (CPM) application difficult
- HO detected in locations other than the hip or knee joint
- Presence of other fractures interfering with bone alkaline phosphatase (AP) levels
- Patients not responding to painful stimuli
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Physical and Rehabilitation Medicine
Ioannina, Epirus, Greece, 45110
Actively Recruiting
Research Team
A
Avraam Ploumis, MD, PhD
CONTACT
G
George I Vasileiadis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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