Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 9:22 PM
Study NCT ID:
NCT05426356
Status:
TERMINATED
Last Update Posted:
2024-10-24
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'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': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects are randomized to sacral fracture fixation and SI joint fusion using iFuse-TORQ vs. non-surgical management (NSM). There is a crossover component for subjects who fail NSM.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Enrollment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time following treatment initiation to reach a 2-point improvement in mobility from baseline as measured using self-rated Modified Functional Mobility scale (MFMS).', 'timeFrame': '1 year', 'description': "The study's primary efficacy endpoint is the time required to achieve an improvement from baseline (study entry) of 2 or more points on the Modified Functional Mobility scale. The scale is administered on a weekly basis following the initiation of treatment until achieving a 2-point improvement or the subject crosses over."}, {'measure': 'Proportion of subjects with serious adverse event (SAE) probably or definitely related to a complication of sacral fracture and/or associated treatment (both arms) or probably or definitely related to iFuse-TORQ (surgery only).', 'timeFrame': '1 year', 'description': 'If randomized to surgery:\n\nProportion of subjects with either:\n\n* Serious adverse event deemed probably or definitely related to iFuse-TORQ\n* Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment\n\nIf randomized to NSM:\n\nProportion of subjects with:\n\n* Serious adverse event deemed probably or definitely a complication of sacral fracture and/or associated treatment'}], 'secondaryOutcomes': [{'measure': 'Continuous Summary Physical Performance Score (CSPPS)', 'timeFrame': '1 year', 'description': 'Change of CSPPS scores at 6 weeks and 12 months. Continuous Summary Physical Performance Score (CSPPS) is a scoring system based on the Short Physical Performance Battery (SPPB) that is optimized for use in the elderly.'}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) physical function', 'timeFrame': '6 weeks', 'description': 'Change from baseline in self reported PROMIS physical function score at 6 weeks. This domain is scored between 1 (unable to do) and 5 (can be done without difficulty).'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '6 weeks', 'description': 'Change from baseline in self reported Oswestry Disability Index at 6 weeks. Calculated scores range from 0 (no disability) to 50 (completely disabled).'}, {'measure': 'Numeric Rating Scale pain score', 'timeFrame': '6 weeks', 'description': 'Change from baseline in self reported Numeric Rating Scale pain score at 6 weeks. Pain scale ranges from 0 (pain free) to 10 (max pain).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Elderly', 'Fragility fracture', 'Pelvic fracture fixation', 'SI Joint Fusion', 'Non-surgical management'], 'conditions': ['Fracture;Pelvis', 'Sacral Fracture', 'Sacroiliac; Fusion', 'Fragility Fracture', 'Insufficiency Fractures', 'Osteoporosis']}, 'descriptionModule': {'briefSummary': 'To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures', 'detailedDescription': 'SAFFRON is a prospective, multicenter, randomized, controlled trial of surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint vs. nonsurgical management (NSM). The goal of the study is to demonstrate the safety, performance, effectiveness, and cost-effectiveness of use of iFuse-TORQ™ in the treatment of sacral fragility or insufficiency fractures vs. NSM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 60 years of age at screening.\n2. Posterior pelvic pain correlating with fracture location that began EITHER within 14 days of a low-energy traumatic event, OR in the last 60 days in the absence of a traumatic event\n3. Imaging (X-ray, CT, or MRI) showing fracture of the sacrum (unilateral or bilateral)\n4. Patient is either bedbound or must use a wheelchair to cover distances more than 50ft\n5. Prior to fracture, patient was able to ambulate using a cane or unassisted\n6. Medically stable to undergo either surgical or non-surgical treatment of index fracture.\n7. Patient is willing and able to provide written informed consent\n8. Patient is mentally able to comply with study protocol requirements\n\nExclusion Criteria:\n\n1. Patient requires surgery to address fracture in the pelvic ring (NSM not feasible)\n2. Anatomic anomalies/defects that would preclude safe and/or biomechanically acceptable placement of implants across the sacroiliac joint (SIJ) and into the sacrum\n3. Sacral fracture potentially or definitely related to tumor\n4. Any permanent implants already in the sacrum (including cement), ilium, or anterior pelvic ring that could interfere with placement of transiliac transsacral or iliosacral screws or iFuse-TORQ implants\n5. History of recent (within 1 year) non-index pelvic fracture with nonunion of sacrum or ilium.\n6. Other clinically active fragility fracture of spine, hip, arms, or legs that could impair recovery from sacral fracture\n7. Uncontrolled psychiatric disease (e.g., dementia, schizophrenia, major depression, personality disorders) that could interfere with study participation or assessments\n8. Prominent neurologic condition that would interfere with study participation including the use of electronic diaries (e.g., dementia) or recovery of mobility (e.g., severe diabetic neuropathy, multiple sclerosis)\n9. Known allergy to titanium or titanium alloys\n10. Current local or systemic infection that raises the risk of surgery.\n11. Known or suspected active drug or alcohol abuse, including opioids.\n12. Patient lives or plans to move more than 100 miles from the site during the course of the study.\n13. Current enrollment in another investigational clinical trial related to fractures or osteoporosis'}, 'identificationModule': {'nctId': 'NCT05426356', 'acronym': 'SAFFRON', 'briefTitle': 'Sacral Fracture Fusion/Fixation for Rapid Rehabilitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'SI-BONE, Inc.'}, 'officialTitle': 'Sacral Fracture Fusion/Fixation for Rapid Rehabilitation', 'orgStudyIdInfo': {'id': '300900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Surgical Treatment', 'description': 'Non-surgical management (NSM) of sacral insufficiency or fragility fractures (SFIF)', 'interventionNames': ['Other: Non-Surgical Management']}, {'type': 'EXPERIMENTAL', 'label': 'Surgical Treatment', 'description': 'Surgical fixation of sacral insufficiency or fragility fractures (SFIF) with concomitant fusion of the sacroiliac (SI) joint', 'interventionNames': ['Device: Surgical Intervention']}], 'interventions': [{'name': 'Surgical Intervention', 'type': 'DEVICE', 'description': 'Surgical sacral fracture fixation and SI joint fusion using iFuse-TORQ', 'armGroupLabels': ['Surgical Treatment']}, {'name': 'Non-Surgical Management', 'type': 'OTHER', 'description': 'Non-surgical management (NSM) is any treatment deemed appropriate for the subject that does not involve surgery.', 'armGroupLabels': ['Non-Surgical Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '68501', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Bryan Health Medical Center', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Saint Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Orthopedic Associates of Reading', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'facility': 'Kadlec Clinic Northwest Orthopedic & Sports Medicine', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}], 'overallOfficials': [{'name': 'Robyn Capobianco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SI-BONE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SI-BONE, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}