Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-01 @ 9:57 AM
Study NCT ID:
NCT06776003
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054854', 'term': 'Vertebroplasty'}], 'ancestors': [{'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physical activity before and after intervention', 'timeFrame': 'One week preoperatively to the end of the fourth postoperative week.', 'description': 'Physical activity is measured by accelerometer and presented as mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day).\n\nAn unweighted average of valid days within the preoperative week is compared with the unweighted average of valid days within the four postoperative weeks by relative change in percent.'}], 'secondaryOutcomes': [{'measure': 'Daily and weekly physical activity', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': 'Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week.'}, {'measure': 'Change in daily and weekly physical activity', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': 'Physical activity is measured by accelerometer and presented as difference in mean ENMO (euclidian norm minus one) and mean TAC/d (total activity count per day). Daily means are based on valid wear-time. Weekly means are calculated as unweighted averages of all valid days within the week.\n\nThis outcome supplements the primary outcome to cover changes within the full study period. Changes are reported as relative percentages.'}, {'measure': 'Physical activity levels', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': 'Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time.'}, {'measure': 'Change in physical activity levels', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': 'Based on cut-points applied to the ENMO or count measurements, the valid wear-time is divided into intensity classes "sedentary", "light activity" or "moderate to vigorous activity". Time spent in each class is presented as percentage of valid wear-time and changes as absolute percentage points.'}, {'measure': 'Total daily distance and change in total daily distance', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': 'Total daily distance traveled in meters based on GPS positions. Changes are relative in percentages.'}, {'measure': 'Time spent stationary and change in time spent stationary', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': "Percentage of time spent stationary based on GPS positions relative to the days' recording. Change is absolute percentage points."}, {'measure': 'Time spent away from home and change in time spent away from home', 'timeFrame': 'One week preoperatively to 4 weeks postoperatively', 'description': "Percentage of time per day where the GPS records a position away from home relative to the days' recordings. Change is in absolute percentage points."}, {'measure': 'Patient-reported pain intensity.', 'timeFrame': 'VAS will be recorded once preoperatively and again 1, 2, 3, 4 and 5 days + 2 and 4 weeks postoperatively.', 'description': 'Pain intensity over the previous 24 hours using the 100-point visual analog scale, where 0 is no pain and 100 is the worst imaginable pain.'}, {'measure': 'Patient-reported disability', 'timeFrame': 'Preoperatively and at 4 weeks postoperatively', 'description': 'The patients rate their disability using the Oswestry Disability Index (ODI) questionnaire.'}, {'measure': 'Patient-reported health-related quality of life.', 'timeFrame': 'Preoperatively and at 4 weeks postoperatively', 'description': 'Health-related quality of life. on the EuroQol 5-dimension 5-level (EQ-5D-5L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accelerometer', 'Global Positioning System', 'Vertebroplasty', 'Physical Activity', 'Mobility', 'Osteoporosis', 'Spinal Surgery', 'ActiGraph', 'Accelerometry', 'GPS', 'Osteoporotic'], 'conditions': ['Osteoporotic Vertebral Compression Fractures']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.\n\nThe focus of the study is on the physical activity and mobility of participants.\n\nThe main questions the trial aims to answer are:\n\n* Does vertebroplasty lead to increased physical activity as measured by accelerometer?\n* Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?\n* Do physical activity and mobility correlate with pain, disability and quality of life?\n\nResearchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility.\n\nParticipants will\n\n* Undergo vertebroplasty or sham procedure\n* Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery\n* Answer questionnaires regarding pain, disability and quality of life at regular intervals.\n\nThe knowledge gained from this can help determine who would benefit from vertebroplasty.', 'detailedDescription': 'Despite attempts at prevention, osteoporotic vertebral fracture occurs with increasing frequency as lifespans increase.\n\nPatients with this disease can experience severe pain and disability, and when conservative treatment is inadequate, vertebroplasty is an option.\n\nIn this surgical procedure, polymethyl metacrylate, or "bone cement" is injected into the fractured vertebral body. However, the procedure is currently controversial for the treatment of osteoporotic vertebral fractures because there is not yet consensus on the efficacy.\n\nBy investigating the effect of vertebroplasty on mobility and physical activity, this study aims to contribute to resolution of the controversy.\n\nThe study is a prospective, double-blind, randomized, sham-controlled clinical trial, where participants will be randomized to either vertebroplasty or a sham operation.\n\nThe study is embedded in the ongoing trial "Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy (VOPE2)" with ClinicalTrials.gov ID NCT06141187.\n\nA subset of the participants in VOPE2 will, in addition to previously planned activities, be equipped with wearable accelerometers and a global positioning system (GPS).\n\nThe trial is designed in accordance with the SPIRIT guidelines.\n\nPotential participants will be identified by referral to the Center for Spine Surgery and Research from general practitioners, chiropractor, physiotherapist, or from hospital inpatient and emergency departments in the region of Southern Denmark.\n\nParticipants will then be examined in an outpatient clinic by a spine surgeon, and have MRI scans and X-ray images analyzed by experienced neuro-radiologists.\n\nIf eligible, they will be offered to participate following informed consent. An accelerometer and GPS-reciever attached to an elastic waist band are initiated following inclusion.\n\nSubjects will initially be stratified into two groups based on the number of OVCFs into 1-2 levels or 3-4 levels.\n\nWithin each of these two groups, randomization sheets in varying blocks of 8 with an equal number of PVP and sham patients in each block will be generated using software (www.randomizer.org) and will be placed in numbered, opaque, sealed envelopes.\n\nTreatment group assignment is 1:1 and will be performed by a scrub nurse in the surgical theatre after the patient is draped but prior to skin incision.\n\nThroughout the trial, only the surgeon and the OR-nurse will have knowledge of the treatment assignment.\n\nThe patient and all assessors remain blinded to the treatment group throughout the study. Spine surgeons who are experienced in PVP will perform the surgical procedures.\n\nAnaesthesiologists and spine surgeons are present at the facility in case of complications, following recommendations by the National Health Authority and have the capacity/capability to decompress the spinal canal in case of cement leakage\n\nBased on qualitative studies and clinical experience, patients with painful osteoporotic vertebral fractures restrict their movement because of pain.\n\nThis in turn leads to reduced physical activity and diminished ability to move oneself around and away from home, defined here as mobility.\n\nIf vertebroplasty is effective, it is expected to lead to increased physical activity and mobility compared to sham, and the outcomes derived from accelerometers and GPS-recievers can supplement patient reports due to their continuous and objective nature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).\n* Focal tenderness on the level of the vertebral fracture.\n* Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence.\n* Osteoporotic Fractures type 1-4.\n* Fracture involves no more than 4 vertebral body levels.\n* Vertebroplasty can be done in one session.\n* Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.\n* Able to understand and read Danish.\n* Written informed consent.\n* Relevant pain started ≤ 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* Contra-indications for spine surgery.\n* Platelets \\< 30 mia/l.\n* Osteoporotic Fractures type 5 and Pincer-type.\n* Complete collapse of the vertebral body precluding insertion of needle.\n* Presence of neurologic deficit.\n* Contraindications for MRI scanning.\n* Psychological or psychiatric disorder that is expected to interfere with compliance.\n* Active malignancy.\n* Mini Mental State Examination (MMSE) test score below 24.\n* History of chronic back pain requiring ongoing opiate use.\n* Systemic or local infection of the spine.'}, 'identificationModule': {'nctId': 'NCT06776003', 'acronym': 'VOPE2 COMPAS', 'briefTitle': 'Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Spine Centre of Southern Denmark'}, 'officialTitle': 'Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '23/40938'}, 'secondaryIdInfos': [{'id': '112199', 'type': 'REGISTRY', 'domain': 'Den Videnskabsetiske Komité for Region Syddanmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vertebroplasty', 'description': 'Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy\n\nInterventions:\n\nProcedure: Vertebroplasty', 'interventionNames': ['Procedure: Vertebroplasty']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham vertebroplasty', 'description': 'A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.\n\nInterventions:\n\nProcedure: Sham Vertebroplasty', 'interventionNames': ['Procedure: Sham Vertebroplasty']}], 'interventions': [{'name': 'Vertebroplasty', 'type': 'PROCEDURE', 'otherNames': ['Percutaneous vertebroplasty', 'PVP'], 'description': 'Polymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy', 'armGroupLabels': ['Vertebroplasty']}, {'name': 'Sham Vertebroplasty', 'type': 'PROCEDURE', 'description': 'A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.', 'armGroupLabels': ['Sham vertebroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Kolding', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Søren W Sørensen, MD', 'role': 'CONTACT', 'email': 'soren.wittorff.sorensen@rsyd.dk', 'phone': '0045 76 36 20 00'}], 'facility': 'Spine Centre of Southern Denmark', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'centralContacts': [{'name': 'Søren W Sørensen, MD', 'role': 'CONTACT', 'email': 'soren.wittorff.sorensen@rsyd.dk', 'phone': '0045 76362000'}], 'overallOfficials': [{'name': 'Mikkel Ø Andersen, Prof, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Spine Centre of Southern Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD and data will be stored for five years from the completetion of the study at the trial site followed by archiving at the Danish National Archives.', 'ipdSharing': 'YES', 'description': 'Data from questionnaires, accelerometers and GPS-records will be made available in an anonymized form to researchers who present a proposal for the use that is reasonable and can be approved by the study authors.', 'accessCriteria': 'Researchers can request access to the information by contacting the investigator via email at soren.wittorff.sorensen@rsyd.dk'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spine Centre of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}