Continuous Passive Motion Versus Heterotopic Ossification

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Conditions
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Traumatic Brain Injury, Spinal Cord Injuries, Stroke

Intervention / Treatment
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* Device: Continuous Passive Motion (CPM)
* Other: Conventional physiotherapy (PT)
* Drug: Zoledronic Acid Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous passive motion (CPM)<br>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. | Device: Continuous Passive Motion (CPM)<br>* CPM 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)<br>Other: Conventional physiotherapy (PT)<br>* Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)<br>Drug: Zoledronic Acid Injection<br>* one dose of intravenous zoledronic acid will be administered<br>|
| Active Comparator: Physiotherapy (PT)<br>10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. | Other: Conventional physiotherapy (PT)<br>* Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)<br>Drug: Zoledronic Acid Injection<br>* one dose of intravenous zoledronic acid will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | According to the literature it is estimated to last approx. 70 days | 
| 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. | According to the literature it is estimated to last approx. 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | According to the literature it is estimated to last approx. 70 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ossification, Heterotopic, continuous passive motion (CPM), zoledronic acid, range of motion (ROM), PROPHYLAXIS