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Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Status: Recruiting
Location: See location...
Intervention Type: Device, Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
Department of Physical and Rehabilitation Medicine
RECRUITING
Ioannina
Contact Information
Primary
Avraam Ploumis, MD, PhD
aploumis@uoi.gr
+ 30 693 2080701
Backup
George I Vasileiadis, MD, PhD
givasileiadis@gmail.com
+ 30 694 5789239
Time Frame
Start Date: 2023-05-12
Estimated Completion Date: 2027-03-25
Participants
Target number of participants: 20
Treatments
Experimental: Continuous passive motion (CPM)
10 ICU patients receiving CPM at HO joints that continuously stretches slowly the joint passively at a constant velocity in a painless range and for a substantial amount of time until there is evidence both laboratory (bone alkaline phosphatase) and radiographically (CT), that osteogenesis has entered a quiescent state. Conventional PT will also be performed.~Plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.
Active_comparator: Physiotherapy (PT)
10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.
Related Therapeutic Areas
Sponsors
Leads: University of Ioannina

This content was sourced from clinicaltrials.gov