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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous passive motion (CPM) | Experimental | 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) | Active Comparator | 10 ICU patients receiving the conventional PT, plus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| ROM lost during the trial | 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 | According to the literature it is estimated to last approx. 70 days |
| HO appearance on CT | 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. | According to the literature it is estimated to last approx. 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Glasgow Coma Scale (GCS) | 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. | According to the literature it is estimated to last approx. 70 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avraam Ploumis, MD, PhD | Contact | + 30 693 2080701 | aploumis@uoi.gr | |
| George I Vasileiadis, MD, PhD | Contact | + 30 694 5789239 | givasileiadis@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical and Rehabilitation Medicine | Recruiting | Ioannina | Epirus | 45110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12872776 | Background | 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. | |
| 34310347 | Background | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013119 | Spinal Cord Injuries |
| D020521 | Stroke |
| D009999 | Ossification, Heterotopic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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randomized control trial
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CT will not reveal the group of patient's origin to the reader
|
| 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 |
|
| 35512120 | Background | 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. |
| 22495100 | Background | 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. |
| 21321512 | Background | 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. |
| 22614800 | Background | 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. |
| 11884494 | Background | Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53. |
| 8675505 | Background | 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. |
| 11475483 | Background | 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. |
| 806274 | Background | Stover SL, Hataway CJ, Zeiger HE. Heterotopic ossification in spinal cord-injured patients. Arch Phys Med Rehabil. 1975 May;56(5):199-204. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |