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NCT Number: NCT05906056

Continuous Passive Motion Versus Heterotopic Ossification

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Passive Motion (CPM)

Device

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)

Conventional physiotherapy (PT)

Other

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

Zoledronic Acid Injection

Drug

one dose of intravenous zoledronic acid will be administered

Primary outcomes

  1. ROM lost during the trial

    Time frame: According to the literature it is estimated to last approx. 70 days

    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

  2. HO appearance on CT

    Time frame: According to the literature it is estimated to last approx. 70 days

    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.

Secondary outcomes

  1. Patient's Glasgow Coma Scale (GCS)

    Time frame: According to the literature it is estimated to last approx. 70 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Avraam Ploumis, MD, PhD

CONTACT

[email protected]

+ 30 693 2080701

George I Vasileiadis, MD, PhD

CONTACT

[email protected]

+ 30 694 5789239

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Acronym: CPMversusHO

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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