Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-02 @ 1:51 AM
Study NCT ID:
NCT07023393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proprio Spine Measurement Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D055035', 'term': 'Spinal Osteochondrosis'}, {'id': 'D013128', 'term': 'Spinal Osteophytosis'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055034', 'term': 'Osteochondrosis'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-06-10', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees', 'timeFrame': 'Pre-operative planned state (enrollment), Postoperative final state (12 months)', 'description': 'Effectiveness of the intraoperative spinal measurement tool will be assessed'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes as measured by the Oswestry Disability Index (ODI)', 'timeFrame': 'Enrollment to 24 months post-operatively', 'description': 'The Oswestry Disability Index (ODI) measures disability in daily living associated with low back pain. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.'}, {'measure': 'Patient Reported Outcomes as measured by the 36-Item Short Form Survey (SF-36)', 'timeFrame': 'Enrollment to 24 months post-operatively', 'description': 'The SF-36 measures health-related quality of life across eight domains, each scored 0-100 (higher = better health). Two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived.'}, {'measure': 'Number of secondary surgeries', 'timeFrame': 'Enrollment to 24 months post-operatively', 'description': 'Number of secondary surgeries will be collected through the electronic health record and from the patient to capture any surgery performed outside Duke.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spine surgery', 'Proprio', 'Spine Measurement', 'Adults', 'Posterior Spine Surgery', 'Spine Fusion', 'Thoracic Spine Surgery', 'Lumbar Spine Surgery', 'Sacral Spine Surgery'], 'conditions': ['Intervertebral Disc Degeneration', 'Intervertebral Disc Displacement', 'Spinal Curvatures', 'Spinal Osteochondrosis', 'Spinal Osteophytosis', 'Spinal Stenosis', 'Spondylitis', 'Spondylosis']}, 'referencesModule': {'references': [{'pmid': '31370009', 'type': 'BACKGROUND', 'citation': 'Finkelstein JA, Schwartz CE. Patient-reported outcomes in spine surgery: past, current, and future directions. J Neurosurg Spine. 2019 Aug 1;31(2):155-164. doi: 10.3171/2019.1.SPINE18770. Epub 2019 Aug 1.'}, {'pmid': '36777909', 'type': 'BACKGROUND', 'citation': 'Beighley A, Zhang A, Huang B, Carr C, Mathkour M, Werner C, Scullen T, Kilgore MD, Maulucci CM, Dallapiazza RF, Kalyvas J. Patient-reported outcome measures in spine surgery: A systematic review. J Craniovertebr Junction Spine. 2022 Oct-Dec;13(4):378-389. doi: 10.4103/jcvjs.jcvjs_101_22. Epub 2022 Dec 7.'}, {'pmid': '34166276', 'type': 'BACKGROUND', 'citation': 'Lau KKL, Samartzis D, To NSC, Harada GK, An HS, Wong AYL. Demographic, Surgical, and Radiographic Risk Factors for Symptomatic Adjacent Segment Disease After Lumbar Fusion: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2021 Aug 4;103(15):1438-1450. doi: 10.2106/JBJS.20.00408.'}, {'pmid': '23773433', 'type': 'BACKGROUND', 'citation': 'Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15.'}, {'pmid': '17043282', 'type': 'BACKGROUND', 'citation': 'Ikard RW. Methods and complications of anterior exposure of the thoracic and lumbar spine. Arch Surg. 2006 Oct;141(10):1025-34. doi: 10.1001/archsurg.141.10.1025.'}]}, 'descriptionModule': {'briefSummary': "This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries.\n\nObjectives\n\nPrimary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively.\n\nSecondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes.\n\nHypothesis\n\nThe application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.", 'detailedDescription': 'Patient reported outcomes data will be collected on two separate forms- the Oswestry Disability Index (ODI) and the SF-36. The ODI has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. The SF-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. Study data will be compared to historical literature data.\n\nThe intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio.\n\nPatients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years or older at the time of surgery\n* Type of Surgery: Consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study\n\nExclusion Criteria:\n\n* Patients treated for traumatic injury (penetrating injuries, etc.)\n* Incarcerated persons\n* Pregnant females\n* Any patient current in another trial for a new implant or technique\n* Non-Spine Related Surgeries: Patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine)\n* Patients having additional surgery occurring concurrently with spine surgery\n* Patients ineligible for surgery'}, 'identificationModule': {'nctId': 'NCT07023393', 'briefTitle': 'Proprio Spine Measurement Tool', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery', 'orgStudyIdInfo': {'id': 'Pro00118206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracolumbosacral posterior spine surgery using intraoperative measurement system', 'description': 'To evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery. Patients may also be included when the surgeon uses another system or method for placement of the implants (i.e., other navigation system, robot, fluoroscopy, etc.) but also wants to utilize the measurement system. The data will be analyzed as a pool and stratified according to level and # of levels and other demographic and operative data to determine if there are differences.', 'interventionNames': ['Device: Intraoperative spinal measurement system']}], 'interventions': [{'name': 'Intraoperative spinal measurement system', 'type': 'DEVICE', 'otherNames': ['Paradigm TM System by Proprio'], 'description': 'The design is a prospective study to evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery.', 'armGroupLabels': ['Thoracolumbosacral posterior spine surgery using intraoperative measurement system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Brett Rocos, MD', 'role': 'CONTACT', 'email': 'brett.rocos@duke.edu', 'phone': '919-620-5168'}, {'name': 'Beth Perry, RN', 'role': 'CONTACT', 'email': 'beth.perry@duke.edu', 'phone': '919-681-2695'}, {'name': 'Brett Rocos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Brett Rocos, MD', 'role': 'CONTACT', 'email': 'brett.rocos@duke.edu', 'phone': '919-620-5168'}, {'name': 'Beth Perry, RN', 'role': 'CONTACT', 'email': 'beth.perry@duke.edu', 'phone': '919-681-2695'}], 'overallOfficials': [{'name': 'Brett Rocos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Proprio Vision, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}