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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Continuous Passive Motion (CPM)
DeviceCPM uses machines to move a joint passively i.e. without the patient exerting any effort. A motorized device moves the joint repetitively to a set of degrees and movement speed, determined by the caregiver either a medical doctor (physiatrist or orthopedic surgeon) or a physiotherapist. Its action preserves the joint's range of motion (ROM)
Conventional physiotherapy (PT)
Other interventionDaily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)
Zoledronic Acid Injection
Drugone dose of intravenous zoledronic acid will be administered
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Continuous passive motion (CPM)Experimental treatment 3 interventions
Group B: Physiotherapy (PT)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
ROM lost during the trial
The difference in ROM between the measurements at baseline and at the end of the The program will last until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state. prophylactic program
Time frame
According to the literature it is estimated to last approx. 70 days2
HO appearance on CT
Based on Brooker HO classification method (between I and IV with IV being bridging bone and joint ankylosis), the difference in CT appearance at baseline and at the end of the program will serve as a descriptive tool. Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state.
Time frame
According to the literature it is estimated to last approx. 70 daysSecondary outcomes
1
Patient's Glasgow Coma Scale (GCS)
Calculation of GCS (range 0-15 with 15 being the normal) at the beginning and at the end of the CPM program.Until there is evidence by CT and laboratory measurements (bone Alkaline Phosphatase) that osteogenesis has entered a quiescent state.
Time frame
According to the literature it is estimated to last approx. 70 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov