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Continuous Passive Motion Versus Heterotopic Ossification

NCT ID: NCT05906056

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2027-03-25

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Spinal Cord Injuries Stroke

Keywords

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Ossification, Heterotopic continuous passive motion (CPM) zoledronic acid range of motion (ROM) PROPHYLAXIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
CT will not reveal the group of patient's origin to the reader

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Passive Motion (CPM)

Intervention Type 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)

Intervention Type OTHER

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

Zoledronic Acid Injection

Intervention Type DRUG

one dose of intravenous zoledronic acid will be administered

Physiotherapy (PT)

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

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy (PT)

Intervention Type OTHER

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

Zoledronic Acid Injection

Intervention Type DRUG

one dose of intravenous zoledronic acid will be administered

Interventions

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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)

Intervention Type DEVICE

Conventional physiotherapy (PT)

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

Intervention Type OTHER

Zoledronic Acid Injection

one dose of intravenous zoledronic acid will be administered

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Avraam Ploumis

Professor of Phyical and Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical and Rehabilitation Medicine

Ioannina, Epirus, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Avraam Ploumis, MD, PhD

Role: CONTACT

Phone: + 30 693 2080701

Email: [email protected]

George I Vasileiadis, MD, PhD

Role: CONTACT

Phone: + 30 694 5789239

Email: [email protected]

References

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Scalzitti DA. Because of the risk of developing heterotopic ossification, are passive range of motion exercises contraindicated following traumatic injuries? Phys Ther. 2003 Jul;83(7):659-7. No abstract available.

Reference Type BACKGROUND
PMID: 12872776 (View on PubMed)

Vasileiadis GI, Varvarousis DN, Manolis I, Ploumis A. The Impact of Continuous Passive Motion on Heterotopic Ossification Maturation. Am J Phys Med Rehabil. 2021 Dec 1;100(12):e194-e197. doi: 10.1097/PHM.0000000000001852.

Reference Type BACKGROUND
PMID: 34310347 (View on PubMed)

Vasileiadis GI, Balta AA, Zerva A, Kontogiannopoulos V, Varvarousis DN, Dimakopoulos G, Ploumis A. Role of Kinesiotherapy in the Prevention of Heterotopic Ossification: A Systematic Review. Am J Phys Med Rehabil. 2023 Feb 1;102(2):110-119. doi: 10.1097/PHM.0000000000002043. Epub 2022 Apr 28.

Reference Type BACKGROUND
PMID: 35512120 (View on PubMed)

Genet F, Chehensse C, Jourdan C, Lautridou C, Denormandie P, Schnitzler A. Impact of the operative delay and the degree of neurologic sequelae on recurrence of excised heterotopic ossification in patients with traumatic brain injury. J Head Trauma Rehabil. 2012 Nov-Dec;27(6):443-8. doi: 10.1097/HTR.0b013e31822b54ba.

Reference Type BACKGROUND
PMID: 22495100 (View on PubMed)

van Kampen PJ, Martina JD, Vos PE, Hoedemaekers CW, Hendricks HT. Potential risk factors for developing heterotopic ossification in patients with severe traumatic brain injury. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):384-91. doi: 10.1097/HTR.0b013e3181f78a59.

Reference Type BACKGROUND
PMID: 21321512 (View on PubMed)

Citak M, Suero EM, Backhaus M, Aach M, Godry H, Meindl R, Schildhauer TA. Risk factors for heterotopic ossification in patients with spinal cord injury: a case-control study of 264 patients. Spine (Phila Pa 1976). 2012 Nov 1;37(23):1953-7. doi: 10.1097/BRS.0b013e31825ee81b.

Reference Type BACKGROUND
PMID: 22614800 (View on PubMed)

Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53.

Reference Type BACKGROUND
PMID: 11884494 (View on PubMed)

Holguin PH, Rico AA, Garcia JP, Del Rio JL. Elbow anchylosis due to postburn heterotopic ossification. J Burn Care Rehabil. 1996 Mar-Apr;17(2):150-4. doi: 10.1097/00004630-199603000-00009.

Reference Type BACKGROUND
PMID: 8675505 (View on PubMed)

Linan E, O'Dell MW, Pierce JM. Continuous passive motion in the management of heterotopic ossification in a brain injured patient. Am J Phys Med Rehabil. 2001 Aug;80(8):614-7. doi: 10.1097/00002060-200108000-00013.

Reference Type BACKGROUND
PMID: 11475483 (View on PubMed)

Stover SL, Hataway CJ, Zeiger HE. Heterotopic ossification in spinal cord-injured patients. Arch Phys Med Rehabil. 1975 May;56(5):199-204.

Reference Type BACKGROUND
PMID: 806274 (View on PubMed)

Other Identifiers

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CPMUIoannina

Identifier Type: -

Identifier Source: org_study_id