Continuous Passive Motion Versus Heterotopic Ossification

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Stroke; Traumatic Brain Injury
• Interventions: Device: Continuous Passive Motion (CPM); Other: Conventional physiotherapy (PT); Drug: Zoledronic Acid Injection

• Registration Number: NCT05906056
• Lead Sponsor: University of Ioannina

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.

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 Timeline

• Study First Submitted: 2023-05-08
• Study Start: 2023-05-12
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-04-25
• Study Completion: 2027-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous passive motion (CPM)	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.
Continuous passive motion (CPM)	Conventional physiotherapy (PT)	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.
Continuous passive motion (CPM)	Zoledronic Acid Injection	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.
Physiotherapy (PT)	Conventional physiotherapy (PT)	10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.
Physiotherapy (PT)	Zoledronic Acid Injection	10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Physical and Rehabilitation Medicine; 🇬🇷 Ioánnina, Epirus, Greece