Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-01 @ 12:17 PM
Study NCT ID:
NCT06670404
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005598', 'term': 'Fractures, Spontaneous'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of sagittal balance', 'timeFrame': 'Up to 12 months post index surgery', 'description': 'measurement of sagittal vertical axis (SVA)'}], 'secondaryOutcomes': [{'measure': 'Improvement in Back Pain', 'timeFrame': 'Up to 12 months post index surgery', 'description': 'Measured as NRS scale for back pain'}, {'measure': 'Quebec Score', 'timeFrame': '6-12 months post index surgery', 'description': 'Measured as the standard Quebec Score'}, {'measure': 'Complications', 'timeFrame': 'Up to 12 months post-index surgery'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['vertebroplasty', 'CONFIDENCE High Viscosity Spinal Cement', 'observational post-market study'], 'conditions': ['Vertebral Compression Fractures', 'Pathological Fracture', 'Facet Joint Arthropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients with vertebral compression fractures from osteoporosis or tumor eligible to be treated with vertebroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years.\n* Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.\n* Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.\n* Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor\n* Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.\n\nStudy Specific Inclusion Criterion • Signed informed consent\n\nExclusion Criteria:\n\n* Infection\n* Vertebral body collapse to less than 1/3 (33%) of original height\n* Vertebral plana (\\>90% vertebral body collapse)\n* Spinal stenosis (retro pulsed fragments).\n* Unstable spine warranting surgical stabilization\n* Prophylactic treatment of any vertebrae with vertebroplasty\n* Irreversible life threating bleeding disorders\n* End stage kidney disease\n* Drug dependence (IVDU)\n* Pregnancy\n\nStudy Specific Exclusion Criterion:\n\n• Unable or unwilling to follow the standard of care prescribed follow-up visits'}, 'identificationModule': {'nctId': 'NCT06670404', 'acronym': 'PROTECT', 'briefTitle': 'Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hirslanden Clinique Bois-Cerf Lausanne'}, 'officialTitle': 'PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures', 'orgStudyIdInfo': {'id': 'THU-2023-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vertebroplasty cohort', 'description': 'Patients with vertebral compression fractures treated with vertebroplasty', 'interventionNames': ['Device: Vertebroplasty']}], 'interventions': [{'name': 'Vertebroplasty', 'type': 'DEVICE', 'description': 'Vertebral compression fractures treated with CONFIDENCE High Viscosity Cement', 'armGroupLabels': ['Vertebroplasty cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nicolas Prof Theumann, Medical Doctor', 'role': 'CONTACT', 'email': 'nicolas.theumann@hirslanden.ch', 'phone': '0041795251859'}], 'facility': 'Clinique Bois Cerf', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Nicolas Prof Theumann, Medical Doctor', 'role': 'CONTACT', 'email': 'nicolas.theumann@hirslanden.ch', 'phone': '0041795251859'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof Nicolas Theumann', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}, {'name': 'Dr Danoob Dalili', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof Nicolas Theumann', 'investigatorAffiliation': 'Hirslanden Clinique Bois-Cerf Lausanne'}}}}