Continuous Passive Motion Versus Heterotopic Ossification (CPMversusHO)

University of Ioannina

Status

Enrolling

Conditions

Traumatic Brain Injury

Stroke

Spinal Cord Injuries

Treatments

Drug: Zoledronic Acid Injection

Device: Continuous Passive Motion (CPM)

Other: Conventional physiotherapy (PT)

Study type

Interventional

Funder types

Other

Identifiers

NCT05906056

CPMUIoannina

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 estimated patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Continuous passive motion (CPM)

Experimental group

Description:

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.

Treatment:

Other: Conventional physiotherapy (PT)

Device: Continuous Passive Motion (CPM)

Drug: Zoledronic Acid Injection

Physiotherapy (PT)

Active Comparator group

Description:

10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.

Treatment:

Other: Conventional physiotherapy (PT)

Drug: Zoledronic Acid Injection