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Recruiting NCT05906056

Continuous Passive Motion Versus Heterotopic Ossification

No phase Interventional Traumatic Brain Injury Spinal Cord Injuries Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Passive Motion (CPM), Conventional physiotherapy (PT), Zoledronic Acid Injection.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Spinal Cord Injuries, Stroke. Basic parameters: 15 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Program of Continuous Passive Motion Exercises Against Heterotopic Ossification

Overview

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.

Interventions

  • 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

Primary outcome measures

  • ROM lost during the trial [Time frame: According to the literature it is estimated to last approx. 70 days]
  • HO appearance on CT [Time frame: According to the literature it is estimated to last approx. 70 days]
Secondary outcome measures (1)
  • Patient's Glasgow Coma Scale (GCS) [Time frame: According to the literature it is estimated to last approx. 70 days]

Eligibility criteria

Inclusion criteria

  • Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.
  • A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)
  • A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)
  • Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.

Exclusion criteria

  • Life-threatening conditions that render Continuous passive motion (CPM) application difficult.
  • HO detected in another location than the hip or knee joint.
  • Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.
  • Patients not reacting to painful stimuli

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Greece · 1 center
  • Department of Physical and Rehabilitation Medicine — Ioannina

Publications

  • 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. PMID 12872776
  • 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. PMID 34310347
  • 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. PMID 35512120
  • 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. PMID 22495100
  • 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. PMID 21321512
  • 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. PMID 22614800
  • Shehab D, Elgazzar AH, Collier BD. Heterotopic ossification. J Nucl Med. 2002 Mar;43(3):346-53. PMID 11884494
  • 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. PMID 8675505

Identifiers

NCT: NCT05906056 · CPMUIoannina

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗