Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-09 @ 5:17 AM
Study NCT ID:
NCT05613257
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Distal Targeter vs Free-hand
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D013978', 'term': 'Tibial Fractures'}, {'id': 'D005599', 'term': 'Fractures, Ununited'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joel.arnold@cshs.org', 'phone': '310-423-9839', 'title': 'Joel Arnold', 'organization': 'Cedars Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the first 30 days after surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Radiation Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.'}, {'id': 'OG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.03', 'spread': '23.56', 'groupId': 'OG000'}, {'value': '10.24', 'spread': '10.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement", 'description': 'Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)', 'unitOfMeasure': 'images taken', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Screw Placement Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.'}, {'id': 'OG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.87', 'spread': '8.86', 'groupId': 'OG000'}, {'value': '15.44', 'spread': '14.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)', 'description': 'time taken to place interlocking screws', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement of Screw Placement Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Zero participants were analyzed as this data metric was not collected.'}, {'id': 'OG001', 'title': 'Distal Targeting Jig', 'description': 'Zero participants were analyzed as this data metric was not collected.'}], 'timeFrame': 'Intraoperatively (at end of surgery)', 'description': 'Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as this data metric was not collected at the end of surgery in any of the participants as there was no reliable way to obtain this measurement.'}, {'type': 'PRIMARY', 'title': 'Amount of Cumulative Radiation Exposure (in Grays)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.'}, {'id': 'OG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement", 'description': 'Total radiation exposure during distal screw placement', 'unitOfMeasure': 'grays', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.'}, {'id': 'FG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Free-hand/Perfect Circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.\n\nFree-hand/perfect circles technique: Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.'}, {'id': 'BG001', 'title': 'Distal Targeting Jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig\n\nDistal targeting jig: Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', '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': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '23.32', 'groupId': 'BG000'}, {'value': '43', 'spread': '22.81', 'groupId': 'BG001'}, {'value': '53', 'spread': '22.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', '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': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-25', 'size': 386176, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-19T17:44', 'hasProtocol': True}, {'date': '2023-10-25', 'size': 919137, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-21T18:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to cohorts based on the operative technique used to treat their respective fractures.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2022-10-31', 'resultsFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-08', 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Radiation Exposure', 'timeFrame': "During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement", 'description': 'Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)'}, {'measure': 'Total Screw Placement Time', 'timeFrame': 'During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)', 'description': 'time taken to place interlocking screws'}, {'measure': 'Measurement of Screw Placement Angle', 'timeFrame': 'Intraoperatively (at end of surgery)', 'description': 'Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole'}, {'measure': 'Amount of Cumulative Radiation Exposure (in Grays)', 'timeFrame': "During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement", 'description': 'Total radiation exposure during distal screw placement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['femur fracture', 'tibia fracture', 'operative time', 'screw placement', 'jig'], 'conditions': ['Femur Fracture', 'Tibial Fractures', 'Nonunion of Fracture', 'Nonunion of Fracture of Tibia', 'Nonunion of Fracture of Femur (Diagnosis)', 'Tibia Fracture']}, 'referencesModule': {'references': [{'pmid': '24714403', 'type': 'BACKGROUND', 'citation': 'Maqungo S, Horn A, Bernstein B, Keel M, Roche S. Distal interlocking screw placement in the femur: free-hand versus electromagnetic assisted technique (sureshot). J Orthop Trauma. 2014 Dec;28(12):e281-3. doi: 10.1097/BOT.0000000000000125.'}, {'pmid': '9781891', 'type': 'BACKGROUND', 'citation': 'Miclau T, Holmes W, Martin RE, Krettek C, Schandelmaier P. Plate osteosynthesis of the distal femur: surgical techniques and results. J South Orthop Assoc. 1998 Fall;7(3):161-70.'}, {'pmid': '16310192', 'type': 'BACKGROUND', 'citation': 'Whatling GM, Nokes LD. Literature review of current techniques for the insertion of distal screws into intramedullary locking nails. Injury. 2006 Feb;37(2):109-19. doi: 10.1016/j.injury.2005.09.009. Epub 2005 Nov 28.'}, {'pmid': '32259266', 'type': 'BACKGROUND', 'citation': "Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215."}, {'pmid': '40892974', 'type': 'DERIVED', 'citation': 'Stanley M, Huang K, Garlich J, Little M, Marecek G, Moon C, Vrahas M, Lin C. A Targeting Arm for Interlocking Screws Reduces Radiation Exposure: Results of a Prospective Randomized Controlled Trial. J Orthop Trauma. 2025 Dec 1;39(12):631-638. doi: 10.1097/BOT.0000000000003066.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.', 'detailedDescription': 'Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and above\n* Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion\n\nExclusion Criteria:\n\n* Prior ipsilateral tibial or femoral nail\n* Patients who cannot have interlocking screws placed\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT05613257', 'briefTitle': 'Distal Targeter vs Free-hand', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement', 'orgStudyIdInfo': {'id': 'STUDY00001778'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Free-hand/perfect circles', 'description': 'Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.', 'interventionNames': ['Procedure: Free-hand/perfect circles technique']}, {'type': 'EXPERIMENTAL', 'label': 'Distal targeting jig', 'description': 'Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig', 'interventionNames': ['Device: Distal targeting jig']}], 'interventions': [{'name': 'Distal targeting jig', 'type': 'DEVICE', 'description': 'Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.', 'armGroupLabels': ['Distal targeting jig']}, {'name': 'Free-hand/perfect circles technique', 'type': 'PROCEDURE', 'description': 'Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.', 'armGroupLabels': ['Free-hand/perfect circles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Nordic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carol A. Lin, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}