Continuous Passive Motion Versus Heterotopic Ossification

Stroke Clinical Trial

— CPMversusHO  

Official title:

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906056
• Other study ID #: CPMUIoannina
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: March 25, 2027

Study information

• Verified date: June 2023
• Source: University of Ioannina
• Contact: Avraam Ploumis, MD, PhD
• Phone: + 30 693 2080701
• Email: aploumis[@]uoi.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 25, 2027
• Est. primary completion date: April 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ossification, Heterotopic
• Spinal Cord Injuries
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Greece	Department of Physical and Rehabilitation Medicine	Ioánnina	Epirus

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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