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RECRUITINGINTERVENTIONAL

Continuous Passive Motion Versus Heterotopic Ossification

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury. 2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT) 3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.) 4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion. Who Should NOT Join This Trial: 1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult. 2. HO detected in another location than the hip or knee joint. 3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level. 4. Patients not reacting to painful stimuli Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury. 2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT) 3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.) 4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion. Exclusion Criteria: 1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult. 2. HO detected in another location than the hip or knee joint. 3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level. 4. Patients not reacting to painful stimuli

Treatments Being Tested

DEVICE

Continuous Passive Motion (CPM)

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)

OTHER

Conventional physiotherapy (PT)

Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)

DRUG

Zoledronic Acid Injection

one dose of intravenous zoledronic acid will be administered

Locations (1)

Department of Physical and Rehabilitation Medicine
Ioannina, Epirus, Greece