Continuous Passive Motion Versus Heterotopic Ossification

NCT05906056 | Recruiting

• 1 other identifier: CPMUIoannina
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Spinal Cord Injuries; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Patient's Glasgow Coma Scale (GCS)

  According to the literature it is estimated to last approx. 70 days

Study Arms (2)

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.

Device: Continuous Passive Motion (CPM); Other: Conventional physiotherapy (PT); Drug: Zoledronic Acid Injection

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.

Other: Conventional physiotherapy (PT); Drug: Zoledronic Acid Injection

Interventions

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)

Continuous passive motion (CPM)

Conventional physiotherapy (PT) OTHER

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

Continuous passive motion (CPM); Physiotherapy (PT)

Zoledronic Acid Injection DRUG

one dose of intravenous zoledronic acid will be administered

Continuous passive motion (CPM); Physiotherapy (PT)

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Department of Physical and Rehabilitation Medicine

Ioannina, Epirus, 45110, Greece

RECRUITING

Related Publications (10)

• 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 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.

  PMID: 34310347 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.

  PMID: 35512120 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.

  PMID: 22495100 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.

  PMID: 21321512 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.

  PMID: 22614800 BACKGROUND

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

  PMID: 11884494 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.

  PMID: 8675505 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.

  PMID: 11475483 BACKGROUND

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

  PMID: 806274 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Spinal Cord Injuries; Stroke; Ossification, Heterotopic

Interventions

Motion Therapy, Continuous Passive; Zoledronic Acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Avraam Ploumis, MD, PhD

CONTACT

+ 30 693 2080701; aploumis@uoi.gr

George I Vasileiadis, MD, PhD

CONTACT

+ 30 694 5789239; givasileiadis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: CT will not reveal the group of patient's origin to the reader
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Phyical and Rehabilitation Medicine

Model Details: randomized control trial

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 15, 2023
• Study Start: May 12, 2023
• Primary Completion: April 25, 2026
• Study Completion (Estimated): March 25, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GR (1)