Continuous Passive Motion Versus Heterotopic Ossification

Launched by UNIVERSITY OF IOANNINA · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether using a Continuous Passive Motion (CPM) device can help prevent a condition called Heterotopic Ossification (HO) in patients who have had a traumatic brain injury, stroke, or spinal cord injury. HO is when bone forms in places where it shouldn't, which can cause pain and limit movement. The trial will involve 20 patients in the ICU: 10 will use the CPM device, while the other 10 will follow standard physiotherapy. By comparing the two groups, researchers hope to find out if CPM can effectively reduce the formation of HO.

To be eligible for the trial, participants must have a stabilized medical condition and show signs of a neurological injury like a stroke or brain injury. They also need to have a specific ultrasound test that rules out blood clots and a bone scan indicating early signs of HO. Patients who have severe health issues that make using the CPM device difficult, or those with HO in areas other than the knee or hip, will not be included. Participants can expect to use the CPM device for a significant amount of time, and they will be monitored closely for any changes in their condition. This trial aims to find a new way to help patients recover and improve their quality of life.

Gender

ALL

Eligibility criteria

• 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