Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:56 PM
Study NCT ID:
NCT07471568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Level of Vertebral Fracture Involved', 'timeFrame': 'Baseline', 'description': 'Distribution of affected vertebral levels (T4-S1)'}, {'measure': 'Mechanism of Injury Distribution', 'timeFrame': 'Baseline', 'description': 'Classification of injury mechanism (falls from height, road accidents, heavy lifting injuries)'}, {'measure': 'Mortality', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Mortality rate documented in the clinical record from the time of injury through the end of follow-up.'}], 'primaryOutcomes': [{'measure': 'Functional Recovery Status at Final Follow-Up', 'timeFrame': 'Up to 12 months after study inclusion or until the final planned follow-up visit.', 'description': 'Degree of functional recovery after treatment of traumatic AO Spine Type A1 vertebral fractures, assessed using the final documented clinical status categories recorded in the medical chart. Functional categories include:\n\nfull recovery minor residual spinal pain partial work disability no return to work permanent disability\n\nHigher categories indicate worse functional outcome (e.g., "full recovery" is the best outcome; "permanent disability" is the worst).'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity Change (VAS)', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Change in pain intensity measured using the Visual Analog Scale for pain (VAS).\n\nThe VAS ranges from 0 to 10, where:\n\n0 = no pain 10 = worst imaginable pain\n\nHigher VAS scores indicate worse pain. The measure compares pre-treatment VAS values with last follow-up VAS values documented in the registry.'}, {'measure': 'Duration of Sick Leave (Days)', 'timeFrame': 'Up to 12 months after injury.', 'description': 'Number of days of temporary work disability, calculated from the injury date to the officially documented date of return to work.'}, {'measure': 'Functional Recovery Status at Final Follow-Up', 'timeFrame': 'Up to 12 months after study inclusion.', 'description': 'Degree of functional recovery after treatment of traumatic AO Type A1 vertebral fractures, assessed using the final documented clinical status ("Full recovery," "Minor residual spinal pain," "Partial work disability," "No return to work," or "Permanent disability") extracted from clinical records.'}, {'measure': 'Return-to-Work Rate', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Proportion of patients who successfully return to work after treatment for traumatic AO Spine Type A1 vertebral fractures, based on documented work-resumption status in the clinical record.'}, {'measure': 'Incidence of Treatment-Related Complications', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Incidence of treatment-related complications documented in the medical record, including persistent pain, secondary procedures, new neurological symptoms, or other adverse events occurring after treatment for traumatic AO Spine Type A1 vertebral fractures.'}, {'measure': 'Radiological Outcomes', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Evaluation of vertebral morphology changes after treatment, including vertebral body height, wedge deformity, and overall structural appearance as documented in radiographic and computed tomography (CT) imaging'}, {'measure': 'Radiological Assessment of Fracture Stability', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Evaluation of radiological signs of stability or instability of the vertebral fracture on radiography and CT, including progression of collapse, kyphotic angulation, or evidence of motion on flexion-extension imaging when available.'}, {'measure': 'Radiological Assessment of Associated Injuries', 'timeFrame': 'Through study completion, up to 12 months after injury.', 'description': 'Detection of associated radiological findings-including edema, ligamentous changes, or other vertebral abnormalities-on magnetic resonance imaging (MRI), CT, or radiography per institutional protocol.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic Vertebral Fracture', 'Spinal Compression Fracture', 'Spinal Trauma', 'Orthopedic Bracing', 'Percutaneous Vertebroplasty', 'Spinal Arthrodesis', 'Work-Related Spinal Injury', 'Return to Work', 'Sick Leave Duration', 'Clinical Outcomes', 'Retrospective Cohort Study', 'AO Spine Type A1 Fracture'], 'conditions': ['Traumatic Vertebral Fractures', 'Compression Fractures of the Spine', 'AO Type A1 Vertebral Fracture', 'Spinal Trauma']}, 'referencesModule': {'references': [{'pmid': '22681740', 'type': 'BACKGROUND', 'citation': 'Singh J, Baker MD, Morris PP, Whitlow CT. Percutaneous pediculoplasty for traumatic pedicle fracture. A technical case report. Interv Neuroradiol. 2012 Jun;18(2):221-6. doi: 10.1177/159101991201800216. Epub 2012 Jun 4.'}, {'pmid': '41013774', 'type': 'BACKGROUND', 'citation': 'Wang J, Yang H, Ganau M, Wang Y, Miao J, Yan L, Wang B. A comparative analysis of three distinct approaches for the management of type A1 traumatic thoracolumbar fractures: a retrospective cohort study with a minimum 6-year follow-up. J Orthop Surg Res. 2025 Sep 26;20(1):856. doi: 10.1186/s13018-025-06262-5.'}, {'pmid': '30402014', 'type': 'BACKGROUND', 'citation': 'Bousson V, Hamze B, Odri G, Funck-Brentano T, Orcel P, Laredo JD. Percutaneous Vertebral Augmentation Techniques in Osteoporotic and Traumatic Fractures. Semin Intervent Radiol. 2018 Oct;35(4):309-323. doi: 10.1055/s-0038-1673639. Epub 2018 Nov 5.'}, {'pmid': '16153574', 'type': 'BACKGROUND', 'citation': 'Perry A, Mahar A, Massie J, Arrieta N, Garfin S, Kim C. Biomechanical evaluation of kyphoplasty with calcium sulfate cement in a cadaveric osteoporotic vertebral compression fracture model. Spine J. 2005 Sep-Oct;5(5):489-93. doi: 10.1016/j.spinee.2005.03.011.'}, {'pmid': '37713855', 'type': 'BACKGROUND', 'citation': 'Hammed A, Mahfoud M, Mohamad O. Effectiveness of unilateral percutaneous vertebroplasty for acute traumatic non-osteoporotic compression vertebral fractures. Medicine (Baltimore). 2023 Sep 15;102(37):e35177. doi: 10.1097/MD.0000000000035177.'}, {'pmid': '19039045', 'type': 'BACKGROUND', 'citation': 'Knavel EM, Thielen KR, Kallmes DF. Vertebroplasty for the treatment of traumatic nonosteoporotic compression fractures. AJNR Am J Neuroradiol. 2009 Feb;30(2):323-7. doi: 10.3174/ajnr.A1356. Epub 2008 Nov 27.'}, {'pmid': '28846351', 'type': 'BACKGROUND', 'citation': 'Donnally III CJ, Margetis K, Varacallo MA. Vertebral Compression Fractures. 2025 May 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448171/'}, {'pmid': '25705347', 'type': 'BACKGROUND', 'citation': 'Kim BG, Dan JM, Shin DE. Treatment of thoracolumbar fracture. Asian Spine J. 2015 Feb;9(1):133-46. doi: 10.4184/asj.2015.9.1.133. Epub 2015 Feb 13.'}, {'pmid': '35000324', 'type': 'BACKGROUND', 'citation': 'Peev N, Zileli M, Sharif S, Arif S, Brady Z. Indications for Nonsurgical Treatment of Thoracolumbar Spine Fractures: WFNS Spine Committee Recommendations. Neurospine. 2021 Dec;18(4):713-724. doi: 10.14245/ns.2142390.195. Epub 2021 Dec 31.'}, {'pmid': '16227897', 'type': 'BACKGROUND', 'citation': 'Vaccaro AR, Lehman RA Jr, Hurlbert RJ, Anderson PA, Harris M, Hedlund R, Harrop J, Dvorak M, Wood K, Fehlings MG, Fisher C, Zeiller SC, Anderson DG, Bono CM, Stock GH, Brown AK, Kuklo T, Oner FC. A new classification of thoracolumbar injuries: the importance of injury morphology, the integrity of the posterior ligamentous complex, and neurologic status. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2325-33. doi: 10.1097/01.brs.0000182986.43345.cb.'}, {'pmid': '19404808', 'type': 'BACKGROUND', 'citation': 'Giele BM, Wiertsema SH, Beelen A, van der Schaaf M, Lucas C, Been HD, Bramer JA. No evidence for the effectiveness of bracing in patients with thoracolumbar fractures. Acta Orthop. 2009 Apr;80(2):226-32. doi: 10.3109/17453670902875245.'}, {'pmid': '28409669', 'type': 'BACKGROUND', 'citation': 'Urquhart JC, Alrehaili OA, Fisher CG, Fleming A, Rasoulinejad P, Gurr K, Bailey SI, Siddiqi F, Bailey CS. Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis. J Neurosurg Spine. 2017 Jul;27(1):42-47. doi: 10.3171/2016.11.SPINE161031. Epub 2017 Apr 14.'}, {'pmid': '7866834', 'type': 'BACKGROUND', 'citation': 'Magerl F, Aebi M, Gertzbein SD, Harms J, Nazarian S. A comprehensive classification of thoracic and lumbar injuries. Eur Spine J. 1994;3(4):184-201. doi: 10.1007/BF02221591.'}, {'pmid': '25953527', 'type': 'BACKGROUND', 'citation': 'Vaccaro AR, Schroeder GD, Kepler CK, Cumhur Oner F, Vialle LR, Kandziora F, Koerner JD, Kurd MF, Reinhold M, Schnake KJ, Chapman J, Aarabi B, Fehlings MG, Dvorak MF. The surgical algorithm for the AOSpine thoracolumbar spine injury classification system. Eur Spine J. 2016 Apr;25(4):1087-94. doi: 10.1007/s00586-015-3982-2. Epub 2015 May 8.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study evaluates three different treatment approaches used for traumatic AO Spine Type A1 (A1) vertebral fractures: orthopedic bracing, percutaneous vertebroplasty, and spinal arthrodesis. Traumatic A1 fractures are stable compression fractures that occur after high-energy events such as falls, traffic accidents, or heavy lifting. These injuries often affect working-age adults and can lead to significant pain, temporary disability, and delays in returning to work. The study analyzes real-world clinical data from patients treated at Hospital 9 de Octubre in Valencia, Spain, between 2007 and 2025. Outcomes assessed include pain levels, duration of sick leave, time to return to work, final functional status, and the presence of complications. By comparing the results of these three treatment strategies, the study aims to identify which approach offers the best clinical recovery and work-related outcomes for patients with traumatic AO Spine Type A1 fractures.', 'detailedDescription': 'Traumatic AO Spine Type A1 (A1) vertebral fractures are stable compression injuries typically caused by high-energy mechanisms such as falls from height, road-traffic accidents, or heavy lifting. These injuries frequently affect adults of working age and may lead to acute pain, temporary functional limitations, and prolonged periods of sick leave. In the clinical setting represented in this study, affected patients underwent one of three treatment strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis.\n\nOrthopedic bracing is the most commonly used conservative approach for stable vertebral compression fractures. In contrast, percutaneous vertebroplasty is a minimally invasive technique that provides immediate internal stabilization via injection of polymethylmethacrylate (PMMA) cement, potentially reducing pain and accelerating functional recovery. Spinal arthrodesis, although more invasive, may be selected in specific traumatic scenarios depending on fracture morphology, associated injuries, or surgeon preference. Despite the frequent use of all three strategies, comparative evidence regarding clinical, functional, and work-related outcomes in traumatic AO Spine Type A1 fractures remains limited.\n\nThis retrospective cohort study examines real-world outcomes of patients with traumatic AO Spine Type A1 vertebral fractures treated at Hospital 9 de Octubre in Valencia, Spain. The study includes clinical data collected between 2007 and 2025, covering patients who were managed with one of the three treatment modalities. Data elements include demographic characteristics, mechanism of injury, fracture level, pre-treatment pain scores, treatment type, functional recovery, duration of sick leave, return-to-work (RTW) dates, and long-term clinical status. These variables are systematically documented in the institutional dataset supporting the project.\n\nImaging studies, including radiographs, computed tomography (CT), and magnetic resonance imaging (MRI), were routinely performed at the institution to evaluate vertebral morphology, rule out ligamentous injury, and assess neurological involvement. Advanced imaging also provided objective confirmation of fracture stability, enabling classification as AO Spine Type A1.\n\nThe primary aim of this study is to compare overall clinical recovery among patients treated with orthopedic bracing, vertebroplasty, or arthrodesis. Secondary outcomes include duration of work disability, pain evolution, and the presence of complications or adverse events. Long-term outcomes are available for many patients, with the latest follow-up recorded in February 2025.\n\nBy analyzing outcomes across these three management strategies, the study seeks to clarify which approach provides the most favorable clinical and occupational results for adults with traumatic AO Spine Type A1 vertebral fractures. The findings may inform clinical decision-making, help refine treatment algorithms, and support more individualized management strategies for this common traumatic condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients aged 18 years or older who sustained traumatic AO Type A1 vertebral fractures and received treatment at Hospital 9 de Octubre in Valencia, Spain. These patients were managed with one of three real-world therapeutic strategies-orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis-and have available clinical and imaging records documenting their injury, treatment, and follow-up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older with a traumatic AO Type A1 vertebral fracture confirmed by clinical records and imaging studies. Patients must have been treated with one of the following management strategies: orthopedic bracing, percutaneous vertebroplasty, or spinal arthrodesis. Complete clinical records must be available for review, including the mechanism of injury, level of the fracture, treatment performed, and follow-up information.\n\nPatients younger than 18 years; patients with non-traumatic or osteoporotic vertebral fractures; vertebral fractures not classified as AO Spine Type A1; cases with incomplete medical records; or patients whose fractures were treated for indications other than trauma. Patients with missing essential follow-up data will also be excluded.'}, 'identificationModule': {'nctId': 'NCT07471568', 'acronym': 'TRAUMA-A1', 'briefTitle': 'Comparison of Three Treatment Strategies for Traumatic AO Type A1 Vertebral Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Comparative Outcomes of Orthopedic Bracing, Percutaneous Vertebroplasty, and Spinal Arthrodesis for Traumatic AO Type A1 Vertebral Fractures: A Retrospective Clinical Study', 'orgStudyIdInfo': {'id': 'UCV2025-2026-091'}, 'secondaryIdInfos': [{'id': 'UCV/2025-2026/093', 'type': 'OTHER', 'domain': 'Ethics committee approval code (Catholic University of Valencia, Spain)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthopedic Bracing', 'description': 'Participants with traumatic AO Type A1 vertebral fractures treated with external orthopedic bracing (conservative management).'}, {'label': 'Percutaneous Vertebroplasty', 'description': 'Participants with traumatic AO Type A1 vertebral fractures treated with percutaneous vertebroplasty using PMMA cement.'}, {'label': 'Spinal Arthrodesis', 'description': 'Participants with traumatic AO Type A1 vertebral fractures treated with surgical spinal fusion (arthrodesis), including instrumented stabilization. \\[bing.com\\]'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Consorcio Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the study is based on retrospective clinical records containing potentially identifiable information, and the ethics committee approval does not include authorization to publicly share individual-level data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Vicente Vanaclocha', 'investigatorAffiliation': 'University of Valencia'}}}}