Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-01-06 @ 3:35 PM
Study NCT ID:
NCT06409559
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment to two different methods of screw and plate fixation of posterior wall acetabulum fractures.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Displacement of posterior wall acetabular fragment', 'timeFrame': '12 months', 'description': 'Measured on immediate post-op CT and compared to measurement one year post-op'}, {'measure': 'Healing of the posterior wall fragment', 'timeFrame': '12 months', 'description': 'Measured on immediate post-op CT and compared to measurement one year post-op'}, {'measure': 'Articular space loss', 'timeFrame': '12 months', 'description': 'Degree and extent of articular space loss (chondrolysis)'}], 'secondaryOutcomes': [{'measure': "Modified Merle d'Aubigne score", 'timeFrame': '12 months', 'description': 'Evaluates pain, gait and mobility'}, {'measure': 'IOWA hip score', 'timeFrame': '12 months', 'description': 'Hip rating system'}, {'measure': 'PROMIS-10 score', 'timeFrame': '12 months', 'description': 'A system of highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being'}, {'measure': 'SMFA score', 'timeFrame': '12 months', 'description': 'Measure the functional status of patients with a broad range of musculoskeletal injuries and disorders'}, {'measure': 'SF 36 score', 'timeFrame': '12 months', 'description': 'Quantifies health status and measures health-related quality of life'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Acetabular Fracture']}, 'referencesModule': {'references': [{'pmid': '14239854', 'type': 'BACKGROUND', 'citation': 'JUDET R, JUDET J, LETOURNEL E. FRACTURES OF THE ACETABULUM: CLASSIFICATION AND SURGICAL APPROACHES FOR OPEN REDUCTION. PRELIMINARY REPORT. J Bone Joint Surg Am. 1964 Dec;46:1615-46. No abstract available.'}, {'pmid': '8934477', 'type': 'BACKGROUND', 'citation': 'Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.'}, {'pmid': '25745901', 'type': 'BACKGROUND', 'citation': 'Moed BR, Kregor PJ, Reilly MC, Stover MD, Vrahas MS. Current management of posterior wall fractures of the acetabulum. Instr Course Lect. 2015;64:139-59.'}, {'pmid': '31311424', 'type': 'BACKGROUND', 'citation': 'Pease F, Ward AJ, Stevenson AJ, Cunningham JL, Sabri O, Acharya M, Chesser T. Posterior wall acetabular fracture fixation: A mechanical analysis of fixation methods. J Orthop Surg (Hong Kong). 2019 Sep-Dec;27(3):2309499019859838. doi: 10.1177/2309499019859838.'}, {'pmid': '9916185', 'type': 'BACKGROUND', 'citation': 'Baumgaertner MR. Fractures of the posterior wall of the acetabulum. J Am Acad Orthop Surg. 1999 Jan;7(1):54-65. doi: 10.5435/00124635-199901000-00006.'}, {'pmid': '13163078', 'type': 'BACKGROUND', 'citation': "D'AUBIGNE RM, POSTEL M. Functional results of hip arthroplasty with acrylic prosthesis. J Bone Joint Surg Am. 1954 Jun;36-A(3):451-75. No abstract available."}, {'pmid': '5888865', 'type': 'BACKGROUND', 'citation': 'Larson CB. Rating scale for hip disabilities. Clin Orthop Relat Res. 1963;31:85-93. No abstract available.'}, {'pmid': '17443115', 'type': 'BACKGROUND', 'citation': 'Reeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, Thissen D, Revicki DA, Weiss DJ, Hambleton RK, Liu H, Gershon R, Reise SP, Lai JS, Cella D; PROMIS Cooperative Group. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007 May;45(5 Suppl 1):S22-31. doi: 10.1097/01.mlr.0000250483.85507.04.'}, {'pmid': '10505521', 'type': 'BACKGROUND', 'citation': 'Swiontkowski MF, Engelberg R, Martin DP, Agel J. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999 Sep;81(9):1245-60. doi: 10.2106/00004623-199909000-00006.'}, {'pmid': '26446970', 'type': 'BACKGROUND', 'citation': 'Laucis NC, Hays RD, Bhattacharyya T. Scoring the SF-36 in Orthopaedics: A Brief Guide. J Bone Joint Surg Am. 2015 Oct 7;97(19):1628-34. doi: 10.2106/JBJS.O.00030.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that the Rim Plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.', 'detailedDescription': 'Study type: Interventional Estimated enrollment: 60 Allocation: block randomization. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.\n\nInterventional model: parallel assignment Description: two different methods of screw and plate fixation of posterior wall acetabulum fractures.\n\nTime perspective: Prospective\n\nPopulation:\n\nSkeletally mature patients who have presented with an acute traumatic fracture of the posterior wall of acetabulum due to dislocation of the femoral head will be included in this study. All surgeons on the study routinely perform both types of repairs.\n\nTreatment arms and Intervention:\n\nArm A: Rim plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.\n\nArm B: Buttress plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Skeletally mature males and females, ≥ 18 years old and with age less than 65 years.\n2. Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan\n3. Operative fixation of fractures within 14 days of presenting to the emergency room.\n4. Patient was ambulatory prior to fracture, with or without walking aids\n5. Medically optimized for operative intervention\n6. Provision of informed consent by patient or legal guardian.\n\nExclusion Criteria:\n\n1. Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).\n2. Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum.\n3. Patients with metabolic bone disease including diagnosis of osteoporosis.\n4. Patients with bony or soft tissue infections around the acetabulum.\n5. Patients unable to provide informed consent.\n6. Patients having other fractures of Pelvis or acetabulum other than an isolated posterior acetabular wall fracture.\n7. Patients with previous history of acetabular fracture (operative or nonoperative)\n8. Patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, Legg-Calve Perthes Disease, or advanced degenerative arthritis.'}, 'identificationModule': {'nctId': 'NCT06409559', 'briefTitle': 'Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'A Randomized Prospective Study Comparing Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws', 'orgStudyIdInfo': {'id': 'OS22025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Rim plate group', 'description': 'This group will consist of patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.', 'interventionNames': ['Device: Pelvic reconstruction plate without interfragmentary screws']}, {'type': 'OTHER', 'label': 'Buttress plate group', 'description': 'This group will consist of patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.', 'interventionNames': ['Device: Pelvic reconstruction plate with interfragmentary screws']}], 'interventions': [{'name': 'Pelvic reconstruction plate without interfragmentary screws', 'type': 'DEVICE', 'description': 'The posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.', 'armGroupLabels': ['Rim plate group']}, {'name': 'Pelvic reconstruction plate with interfragmentary screws', 'type': 'DEVICE', 'description': 'The posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.', 'armGroupLabels': ['Buttress plate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Hasselfeld', 'role': 'CONTACT', 'email': 'hasselky@uc.edu', 'phone': '5137776213'}, {'name': 'Henry C Sagi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Cincinnati College of Medicine', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Kimberly A Hasselfeld', 'role': 'CONTACT', 'email': 'hasselky@uc.edu', 'phone': '5135581933'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'H. Claude Sagi, MD', 'investigatorAffiliation': 'University of Cincinnati'}}}}