[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508871":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":47,"responsibleParty":62,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Ioannina","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nPlus a single dose of zoledronic acid (Aclasta) once the diagnosis of HO is made.",[13,14,15],"Device: Continuous Passive Motion (CPM)","Other: Conventional physiotherapy (PT)","Drug: Zoledronic Acid Injection",{"label":17,"type":18,"description":19,"interventionNames":20},"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.",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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)",[9],null,{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Conventional physiotherapy (PT)","Daily passive range of motion exercises (ROM) performed by the physiotherapist of the intensive care unit (ICU)",[9,17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DRUG","Zoledronic Acid Injection","one dose of intravenous zoledronic acid will be administered",[9,17],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Avraam Ploumis, MD, PhD","CONTACT","+ 30 693 2080701","aploumis@uoi.gr",{"name":44,"role":40,"phone":45,"phoneExt":27,"email":46},"George I Vasileiadis, MD, PhD","+ 30 694 5789239","givasileiadis@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":27},"Department of Physical and Rehabilitation Medicine","RECRUITING","Ioannina","Epirus","45110","Greece","GR",{"type":57,"coordinates":58},"Point",[59,60],20.85187,39.66341,{"lat":60,"lon":59},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Avraam Ploumis","Professor of Phyical and Rehabilitation Medicine","100508871","continuous-passive-motion-versus-heterotopic-ossification-100508871",false,"NCT05906056","Continuous Passive Motion Versus Heterotopic Ossification","Program of Continuous Passive Motion Exercises Against Heterotopic Ossification","CPMversusHO","Inclusion Criteria:\n\n1. Patients with stabilized medical condition suffering from neurological insult either traumatic brain injury (TBI), stroke, or Spinal Cord Injury.\n2. A negative triplex ultrasound in order to rule out deep venous thrombosis (DVT)\n3. A positive three-phase bone scan with Tc99. (Will be obtained as soon as HO symptoms are onset.)\n4. Patients with verified HO formation on the knee or hip joint will undergo a CT to show the extent of the lesion.\n\nExclusion Criteria:\n\n1. Life-threatening conditions that render Continuous passive motion (CPM) application difficult.\n2. HO detected in another location than the hip or knee joint.\n3. Concomitantly presence of other fractures that will interfere with the bone alkaline phosphatase (AP) level.\n4. Patients not reacting to painful stimuli","ALL","15 Years","70 Years",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.",[85,86,87],"Traumatic Brain Injury","Spinal Cord Injuries","Stroke",[89,90,91,92,93],"Ossification, Heterotopic","continuous passive motion (CPM)","zoledronic acid","range of motion (ROM)","PROPHYLAXIS","2024-12-04",{"date":96,"type":97},"2024-12-06","ACTUAL",{"date":99,"type":97},"2023-05-12",{"date":101,"type":79},"2027-03-25",{"name":5,"class":6},1]