CPMversusHO: Continuous Passive Motion Versus Heterotopic Ossification

Sponsor
University of Ioannina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05906056
Collaborator
(none)
20
1
2
46.4
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous Passive Motion (CPM)
  • Other: Conventional physiotherapy (PT)
  • Drug: Zoledronic Acid Injection
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized control trialrandomized control trial
Masking:
Single (Outcomes Assessor)
Masking Description:
CT will not reveal the group of patient's origin to the reader
Primary Purpose:
Prevention
Official Title:
Program of Continuous Passive Motion Exercises Against Heterotopic Ossification
Actual Study Start Date :
May 12, 2023
Anticipated Primary Completion Date :
Apr 25, 2026
Anticipated Study Completion Date :
Mar 25, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Continuous passive motion (CPM)

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)
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

Active Comparator: Physiotherapy (PT)

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)
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

Outcome Measures

Primary Outcome Measures

  1. ROM lost during the trial [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 [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 Outcome Measures

  1. Patient's Glasgow Coma Scale (GCS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical and Rehabilitation Medicine Ioánnina Epirus Greece 45110

Sponsors and Collaborators

  • University of Ioannina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Avraam Ploumis, Professor of Phyical and Rehabilitation Medicine, University of Ioannina
ClinicalTrials.gov Identifier:
NCT05906056
Other Study ID Numbers:
  • CPMUIoannina
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Avraam Ploumis, Professor of Phyical and Rehabilitation Medicine, University of Ioannina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023