Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-05 @ 10:05 PM
Study NCT ID:
NCT06343467
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'megan.reams@tria.com', 'phone': '(952) 806-5329', 'title': 'Megan Reams; Director of Orthopaedic Research', 'organization': 'TRIA Orthopedic Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days postoperatively', 'eventGroups': [{'id': 'EG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm.", 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '90-day Reoperation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Reoperation for any reason postoperatively within 90 days after the date of surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '90-day Readmission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '90-day Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Patient death at any point within 90 days after the date of surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Implant Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '702.38', 'spread': '47.83', 'groupId': 'OG000'}, {'value': '1348.61', 'spread': '100.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of Surgery', 'description': 'The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.', 'unitOfMeasure': 'United States Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tourniquet Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '49.05', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '45.06', 'spread': '12.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From tourniquet inflation to deflation during the procedure.', 'description': 'The total time in minutes from tourniquet inflation to deflation for a surgical case.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'OG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of Surgery', 'description': 'Estimated blood loss for the surgical case as reported by the surgeon in milliliters.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'FG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Detailed physical examination of patient with radiographic evaluation of distal radius fracture and indication for volar locking plate open reduction and internal fixation. Patients with open fracture observed on physical examination, polytrauma (any other fracture or medical instability), metaphyseal extension of the fracture, age less than 18 years, and fracture pattern not suitable for fixation with volar locking plate were excluded before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.\n\nGeneric Volar Locking Plate: Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.'}, {'id': 'BG001', 'title': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.\n\nConventional Volar Locking Plate: Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.75', 'spread': '12.16', 'groupId': 'BG000'}, {'value': '60.74', 'spread': '11.37', 'groupId': 'BG001'}, {'value': '61.03', 'spread': '11.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-16', 'size': 218626, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-14T00:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-03-14', 'resultsFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-06', 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day Reoperation Rate', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Reoperation for any reason postoperatively within 90 days after the date of surgery.'}, {'measure': '90-day Readmission Rate', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Readmission to the hospital for any reason postoperatively within 90 days after the date of surgery.'}, {'measure': '90-day Mortality Rate', 'timeFrame': 'Within 90 days postoperatively', 'description': 'Patient death at any point within 90 days after the date of surgery.'}], 'secondaryOutcomes': [{'measure': 'Implant Cost', 'timeFrame': 'Day of Surgery', 'description': 'The total cost of implants used in the procedure, including screws, pegs, volar locking plates, and disposable implants.'}, {'measure': 'Tourniquet Time', 'timeFrame': 'From tourniquet inflation to deflation during the procedure.', 'description': 'The total time in minutes from tourniquet inflation to deflation for a surgical case.'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'Day of Surgery', 'description': 'Estimated blood loss for the surgical case as reported by the surgeon in milliliters.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Volar Locking Plate', 'Generic Implants'], 'conditions': ['Distal Radius Fractures']}, 'referencesModule': {'references': [{'pmid': '27870671', 'type': 'BACKGROUND', 'citation': 'Walker JA, Althausen PL. Surgeon Attitudes Regarding the Use of Generic Implants: An OTA Survey Study. J Orthop Trauma. 2016 Dec;30 Suppl 5:S27-S31. doi: 10.1097/BOT.0000000000000722.'}, {'pmid': '29762154', 'type': 'BACKGROUND', 'citation': 'Waldrop VH, Laverty DC, Bozic KJ. Value-based Healthcare: Increasing Value by Reducing Implant-related Health Care Costs. Clin Orthop Relat Res. 2019 Feb;477(2):281-283. doi: 10.1097/01.blo.0000534683.24250.9c. No abstract available.'}, {'pmid': '36246025', 'type': 'BACKGROUND', 'citation': 'Miner HR, Slover JD, Koenig KM. Price Transparency and Consumer Perceptions of Generic and Brand-name Implants in Orthopaedic Surgery. Arch Bone Jt Surg. 2022 Sep;10(9):791-797. doi: 10.22038/ABJS.2022.51855.2558.'}, {'pmid': '27870672', 'type': 'BACKGROUND', 'citation': 'Mcphillamy A, Gurnea TP, Moody AE, Kurnik CG, Lu M. The Clinical and Economic Impact of Generic Locking Plate Utilization at a Level II Trauma Center. J Orthop Trauma. 2016 Dec;30 Suppl 5:S32-S36. doi: 10.1097/BOT.0000000000000721.'}, {'pmid': '34715691', 'type': 'BACKGROUND', 'citation': 'Khoo KM, Kim GW, Lindvall EM, Martirosian AK. Outcomes and Cost Comparison Between Generic and Conventional Cephalomedullary Nails in the Treatment of Peritrochanteric Femur Fractures. J Am Acad Orthop Surg. 2022 Feb 1;30(3):119-124. doi: 10.5435/JAAOS-D-21-00024.'}, {'pmid': '37428150', 'type': 'BACKGROUND', 'citation': 'Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. A Case Series of Surgically Treated Distal Radius Fractures: Implant Costs and Their Effect on Patient Outcomes. J Am Acad Orthop Surg Glob Res Rev. 2023 Jul 7;7(7):e23.00026. doi: 10.5435/JAAOSGlobal-D-23-00026. eCollection 2023 Jul 1.'}, {'pmid': '37125012', 'type': 'BACKGROUND', 'citation': 'Doxey SA, Huyke-Hernandez FA, Robb JL, Bohn DC, Cunningham BP. Implant cost variation in surgically treated distal radius fractures. J Orthop. 2023 Apr 7;39:45-49. doi: 10.1016/j.jor.2023.04.003. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': "Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review.", 'detailedDescription': "Patients will be consented to surgery per a standard surgical consent form. Six surgeons who regularly perform distal radius fracture (DRF) ORIF are included (five hand and one orthopaedic trauma fellowship-trained). Per the practice protocol, patients will either be treated with a generic plate or a brand name plate as described above. Ultimately, the decision to use a generic volar locking plate (VLP) is left up to surgeon discretion. All surgical and follow-up data will be collected. Implants used, age at time of surgery, weight, height, gender, race, ethnicity, comorbidities (diabetes, heart disease, etc.), complications including, but not limited to: readmission, reoperation, non-union, wound dehiscence, and lab tests will be collected. This will be evaluated all within 90 days following surgery. Implants will be cross referenced with the institution's data base to determine cost. All data will be collected on a secure server and be kept password protected. The primary outcome was 90-day postoperative complications (readmissions, reoperations, and mortality rates) by implant vendor type (generic vs. conventional). Secondary outcomes consisted of implant costs, estimated blood loss, and tourniquet time. An a priori power analysis was conducted to estimate the minimum sample size needed to adequately detect a difference in reoperation rates with a large effect size (Cohen's d=0.8). At a Type I error rate of 0.05, a power of 80%, and a 1:1 group allocation, the estimated sample size was 36 patients (18 generic VLPs vs. 18 conventional VLPs). Statistical significance was set to p≤0.05."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated distal radius fracture\n* Treated surgically with a volar locking plate\n\nExclusion Criteria:\n\n* Volar locking plate not used\n* Additional fixation was used\n* Polytrauma (non-isolated injury)\n* Open fracture\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT06343467', 'briefTitle': 'Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?', 'organization': {'class': 'OTHER', 'fullName': 'HealthPartners Institute'}, 'officialTitle': 'Generic Volar Locking Plate Use in Distal Radius Fractures: A Prospective Randomized Study to Evaluate Clinical Outcomes and Cost Reduction', 'orgStudyIdInfo': {'id': 'A17-376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Generic Implant', 'description': 'Patients with an isolated distal radius fracture are treated surgically with a generic volar locking plate. All other surgical protocols remain unchanged.', 'interventionNames': ['Device: Generic Volar Locking Plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Implant', 'description': "Patients with an isolated distal radius fracture are treated surgically with a conventional, brand name volar locking plate of the surgeon's choice. All other surgical protocols remain unchanged.", 'interventionNames': ['Device: Conventional Volar Locking Plate']}], 'interventions': [{'name': 'Generic Volar Locking Plate', 'type': 'DEVICE', 'description': 'Application of a generic volar locking plate is done in the generic implant arm compared to the other commonly used implants by surgeons in the conventional implant arm.', 'armGroupLabels': ['Generic Implant']}, {'name': 'Conventional Volar Locking Plate', 'type': 'DEVICE', 'description': 'Application of a conventional, brand name volar locking plate is done in the conventional implant arm compared to the generic implant arm.', 'armGroupLabels': ['Conventional Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Brian Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HealthPartners Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "This data will remain confidential and de-identified on our institution's servers."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HealthPartners Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}