CPMversusHO: Continuous Passive Motion Versus Heterotopic Ossification
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 |
|---|---|---|
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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
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
- 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
- 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
Inclusion Criteria:
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Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
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A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
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A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
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Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.
Exclusion Criteria:
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Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
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HO detected in another location than the hip or knee joint.
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Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
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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
- 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.
- 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.
- 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.
- 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.
- 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.
- Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53.
- Stover SL, Hataway CJ, Zeiger HE. Heterotopic ossification in spinal cord-injured patients. Arch Phys Med Rehabil. 1975 May;56(5):199-204.
- 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.
- 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.
- 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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