Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT02418260
Status:
UNKNOWN
Last Update Posted:
2017-10-06
First Post:
2015-04-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Interventions for the Treatment of Humeral Shaft Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2015-04-15', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)', 'timeFrame': '48 weeks', 'description': 'The survey will be applied at 8, 24 and 48 weeks after the intervention'}], 'secondaryOutcomes': [{'measure': 'Changes in the Visual Analog Scale for Pain (VAS)', 'timeFrame': '48 weeks', 'description': 'The VAS survey will be applied 1, 8, 24 and 48 weeks after the intervention'}, {'measure': 'Changes in the Constant-Murley Shoulder Outcome Score', 'timeFrame': '48 weeks', 'description': 'The Score will be obtained at 8, 24 and 48 weeks after the intervention'}, {'measure': 'Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)', 'timeFrame': '48 weeks', 'description': 'Complications are defined as nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow.'}, {'measure': 'Radiographic angular deformity', 'timeFrame': 'at 48 weeks', 'description': 'Radiographic angular residual deformity will be measured at 48 weeks after the surgical procedure.'}, {'measure': 'Time to previous activities return', 'timeFrame': '48 weeks', 'description': 'time to return to previous acitivities will bem described in weeks after the surgery'}, {'measure': 'Failure (need for aditional surgical procedure)', 'timeFrame': '48 weeks', 'description': 'Failure is described as need for aditional surgical procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Humerus', 'shaft', 'diaphyseal', 'fractures'], 'conditions': ['Fracture of Shaft of Humerus', 'Humerus Fracture']}, 'referencesModule': {'references': [{'pmid': '14261543', 'type': 'BACKGROUND', 'citation': 'MANN RJ, NEAL EG. FRACTURES OF THE SHAFT OF THE HUMERUS IN ADULTS. South Med J. 1965 Mar;58:264-8. doi: 10.1097/00007611-196503000-00002. No abstract available.'}, {'pmid': '7105548', 'type': 'BACKGROUND', 'citation': 'Rose SH, Melton LJ 3rd, Morrey BF, Ilstrup DM, Riggs BL. Epidemiologic features of humeral fractures. Clin Orthop Relat Res. 1982 Aug;(168):24-30.'}, {'type': 'BACKGROUND', 'citation': "McKee MD LS. Humeral Shaft Fractures. Rockwood and Green's Fractures in Adults. 7th ed. Philadelphia: Lippincot Williams & Wilkins; 2009"}, {'pmid': '10341891', 'type': 'BACKGROUND', 'citation': 'Baumgaertel F, Buhl M, Rahn BA. Fracture healing in biological plate osteosynthesis. Injury. 1998;29 Suppl 3:C3-6. doi: 10.1016/s0020-1383(98)95002-1.'}, {'pmid': '11407801', 'type': 'BACKGROUND', 'citation': "Bhandari M, Guyatt GH, Swiontkowski MF. User's guide to the orthopaedic literature: how to use an article about a surgical therapy. J Bone Joint Surg Am. 2001 Jun;83(6):916-26. doi: 10.2106/00004623-200106000-00015. No abstract available."}, {'pmid': '21350618', 'type': 'BACKGROUND', 'citation': 'Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.'}, {'type': 'BACKGROUND', 'citation': "Solway S, Beaton, D.E., McConnell, S., & Bombardier, C. The DASH Outcome measure user's manual (2nd Edition). Institute for Work & Health. Toronto2002."}, {'pmid': '15785841', 'type': 'BACKGROUND', 'citation': 'Orfale AG, Araujo PM, Ferraz MB, Natour J. Translation into Brazilian Portuguese, cultural adaptation and evaluation of the reliability of the Disabilities of the Arm, Shoulder and Hand Questionnaire. Braz J Med Biol Res. 2005 Feb;38(2):293-302. doi: 10.1590/s0100-879x2005000200018. Epub 2005 Feb 15.'}, {'pmid': '2039061', 'type': 'BACKGROUND', 'citation': 'Flandry F, Hunt JP, Terry GC, Hughston JC. Analysis of subjective knee complaints using visual analog scales. Am J Sports Med. 1991 Mar-Apr;19(2):112-8. doi: 10.1177/036354659101900204.'}, {'pmid': '3791738', 'type': 'BACKGROUND', 'citation': 'Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.'}, {'pmid': '7838503', 'type': 'RESULT', 'citation': 'Balfour GW, Marrero CE. Fracture brace for the treatment of humerus shaft fractures caused by gunshot wounds. Orthop Clin North Am. 1995 Jan;26(1):55-63.'}, {'pmid': '873955', 'type': 'RESULT', 'citation': 'Sarmiento A, Kinman PB, Galvin EG, Schmitt RH, Phillips JG. Functional bracing of fractures of the shaft of the humerus. J Bone Joint Surg Am. 1977 Jul;59(5):596-601.'}, {'type': 'RESULT', 'citation': 'Ward EF SF, Hughes JL. Fractures of the diaphyseal humerus. In: Saunders, ed. Skeletal trauma: fractures, dislocation, ligamentous injuries. Philadelphia: Saunders; 1998:1523-47'}, {'pmid': '7054192', 'type': 'RESULT', 'citation': 'Balfour GW, Mooney V, Ashby ME. Diaphyseal fractures of the humerus treated with a ready-made fracture brace. J Bone Joint Surg Am. 1982 Jan;64(1):11-3. No abstract available.'}, {'pmid': '8326423', 'type': 'RESULT', 'citation': 'Amillo S, Barrios RH, Martinez-Peric R, Losada JI. Surgical treatment of the radial nerve lesions associated with fractures of the humerus. J Orthop Trauma. 1993;7(3):211-5. doi: 10.1097/00005131-199306000-00002.'}, {'pmid': '8423295', 'type': 'RESULT', 'citation': 'Foster RJ, Swiontkowski MF, Bach AW, Sack JT. Radial nerve palsy caused by open humeral shaft fractures. J Hand Surg Am. 1993 Jan;18(1):121-4. doi: 10.1016/0363-5023(93)90255-2.'}, {'pmid': '7462281', 'type': 'RESULT', 'citation': 'Pollock FH, Drake D, Bovill EG, Day L, Trafton PG. Treatment of radial neuropathy associated with fractures of the humerus. J Bone Joint Surg Am. 1981 Feb;63(2):239-43.'}, {'pmid': '17088659', 'type': 'RESULT', 'citation': 'Ekholm R, Tidermark J, Tornkvist H, Adami J, Ponzer S. Outcome after closed functional treatment of humeral shaft fractures. J Orthop Trauma. 2006 Oct;20(9):591-6. doi: 10.1097/01.bot.0000246466.01287.04.'}, {'pmid': '17088660', 'type': 'RESULT', 'citation': 'Rutgers M, Ring D. Treatment of diaphyseal fractures of the humerus using a functional brace. J Orthop Trauma. 2006 Oct;20(9):597-601. doi: 10.1097/01.bot.0000249423.48074.82.'}, {'pmid': '17079389', 'type': 'RESULT', 'citation': 'Jawa A, McCarty P, Doornberg J, Harris M, Ring D. Extra-articular distal-third diaphyseal fractures of the humerus. A comparison of functional bracing and plate fixation. J Bone Joint Surg Am. 2006 Nov;88(11):2343-7. doi: 10.2106/JBJS.F.00334.'}, {'pmid': '22258990', 'type': 'RESULT', 'citation': 'Gosler MW, Testroote M, Morrenhof JW, Janzing HM. Surgical versus non-surgical interventions for treating humeral shaft fractures in adults. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008832. doi: 10.1002/14651858.CD008832.pub2.'}, {'pmid': '19523625', 'type': 'RESULT', 'citation': 'Papasoulis E, Drosos GI, Ververidis AN, Verettas DA. Functional bracing of humeral shaft fractures. A review of clinical studies. Injury. 2010 Jul;41(7):e21-27. doi: 10.1016/j.injury.2009.05.004. Epub 2009 Jun 11.'}, {'pmid': '3356728', 'type': 'RESULT', 'citation': 'Zagorski JB, Latta LL, Zych GA, Finnieston AR. Diaphyseal fractures of the humerus. Treatment with prefabricated braces. J Bone Joint Surg Am. 1988 Apr;70(4):607-10.'}, {'pmid': '9258827', 'type': 'RESULT', 'citation': 'Wallny T, Westermann K, Sagebiel C, Reimer M, Wagner UA. Functional treatment of humeral shaft fractures: indications and results. J Orthop Trauma. 1997 May;11(4):283-7. doi: 10.1097/00005131-199705000-00011.'}, {'pmid': '10853896', 'type': 'RESULT', 'citation': 'Fjalestad T, Stromsoe K, Salvesen P, Rostad B. Functional results of braced humeral diaphyseal fractures: why do 38% lose external rotation of the shoulder? Arch Orthop Trauma Surg. 2000;120(5-6):281-5. doi: 10.1007/s004020050465.'}, {'pmid': '11988725', 'type': 'RESULT', 'citation': 'Koch PP, Gross DF, Gerber C. The results of functional (Sarmiento) bracing of humeral shaft fractures. J Shoulder Elbow Surg. 2002 Mar-Apr;11(2):143-50. doi: 10.1067/mse.2002.121634.'}, {'pmid': '4066292', 'type': 'RESULT', 'citation': 'Ricciardi-Pollini PT, Falez F. The treatment of diaphyseal fractures by functional bracing. Results in 36 cases. Ital J Orthop Traumatol. 1985 Jun;11(2):199-205.'}, {'pmid': '17452711', 'type': 'RESULT', 'citation': 'Persad IJ, Kommu S. U cast or functional bracing following fractures of the shaft of humerus. Emerg Med J. 2007 May;24(5):361. doi: 10.1136/emj.2007.048504. No abstract available.'}, {'pmid': '9498146', 'type': 'RESULT', 'citation': 'Wallny T, Sagebiel C, Westerman K, Wagner UA, Reimer M. Comparative results of bracing and interlocking nailing in the treatment of humeral shaft fractures. Int Orthop. 1997;21(6):374-9. doi: 10.1007/s002640050189.'}, {'pmid': '3980544', 'type': 'RESULT', 'citation': 'Bell MJ, Beauchamp CG, Kellam JK, McMurtry RY. The results of plating humeral shaft fractures in patients with multiple injuries. The Sunnybrook experience. J Bone Joint Surg Br. 1985 Mar;67(2):293-6. doi: 10.1302/0301-620X.67B2.3980544.'}, {'pmid': '1556609', 'type': 'RESULT', 'citation': "Dabezies EJ, Banta CJ 2nd, Murphy CP, d'Ambrosia RD. Plate fixation of the humeral shaft for acute fractures, with and without radial nerve injuries. J Orthop Trauma. 1992;6(1):10-3."}, {'pmid': '8355300', 'type': 'RESULT', 'citation': 'Heim D, Herkert F, Hess P, Regazzoni P. Surgical treatment of humeral shaft fractures--the Basel experience. J Trauma. 1993 Aug;35(2):226-32.'}, {'pmid': '21915231', 'type': 'RESULT', 'citation': 'Grass G, Kabir K, Ohse J, Rangger C, Besch L, Mathiak G. Primary Exploration of Radial Nerve is Not Required for Radial Nerve Palsy while Treating Humerus Shaft Fractures with Unreamed Humerus Nails (UHN). Open Orthop J. 2011;5:319-23. doi: 10.2174/1874325001105010319. Epub 2011 Aug 26.'}, {'pmid': '15714304', 'type': 'RESULT', 'citation': 'Chao TC, Chou WY, Chung JC, Hsu CJ. Humeral shaft fractures treated by dynamic compression plates, Ender nails and interlocking nails. Int Orthop. 2005 Apr;29(2):88-91. doi: 10.1007/s00264-004-0620-8. Epub 2005 Feb 16.'}, {'pmid': '11600115', 'type': 'RESULT', 'citation': "Ajmal M, O'Sullivan M, McCabe J, Curtin W. Antegrade locked intramedullary nailing in humeral shaft fractures. Injury. 2001 Nov;32(9):692-4. doi: 10.1016/s0020-1383(01)00076-6."}, {'pmid': '15168178', 'type': 'RESULT', 'citation': 'Petsatodes G, Karataglis D, Papadopoulos P, Christoforides J, Gigis J, Pournaras J. Antegrade interlocking nailing of humeral shaft fractures. J Orthop Sci. 2004;9(3):247-52. doi: 10.1007/s00776-004-0780-9.'}, {'pmid': '22659630', 'type': 'RESULT', 'citation': 'Aksu N, Karaca S, Kara AN, Isiklar ZU. Minimally invasive plate osteosynthesis (MIPO) in diaphyseal humerus and proximal humerus fractures. Acta Orthop Traumatol Turc. 2012;46(3):154-60. doi: 10.3944/aott.2012.2592.'}, {'pmid': '22144745', 'type': 'RESULT', 'citation': 'Shetty MS, Kumar MA, Sujay K, Kini AR, Kanthi KG. Minimally invasive plate osteosynthesis for humerus diaphyseal fractures. Indian J Orthop. 2011 Nov;45(6):520-6. doi: 10.4103/0019-5413.87123.'}, {'pmid': '22947239', 'type': 'RESULT', 'citation': 'Ouyang H, Xiong J, Xiang P, Cui Z, Chen L, Yu B. Plate versus intramedullary nail fixation in the treatment of humeral shaft fractures: an updated meta-analysis. J Shoulder Elbow Surg. 2013 Mar;22(3):387-95. doi: 10.1016/j.jse.2012.06.007. Epub 2012 Sep 1.'}, {'pmid': '23994004', 'type': 'RESULT', 'citation': 'Liu GD, Zhang QG, Ou S, Zhou LS, Fei J, Chen HW, Nan GX, Gu JW. Meta-analysis of the outcomes of intramedullary nailing and plate fixation of humeral shaft fractures. Int J Surg. 2013;11(9):864-8. doi: 10.1016/j.ijsu.2013.08.002. Epub 2013 Aug 28.'}, {'pmid': '23471713', 'type': 'RESULT', 'citation': 'Wang X, Chen Z, Shao Y, Ma Y, Fu D, Xia Q. A meta-analysis of plate fixation versus intramedullary nailing for humeral shaft fractures. J Orthop Sci. 2013 May;18(3):388-97. doi: 10.1007/s00776-013-0355-8. Epub 2013 Mar 8.'}, {'pmid': '16752291', 'type': 'RESULT', 'citation': 'Bhandari M, Devereaux PJ, McKee MD, Schemitsch EH. Compression plating versus intramedullary nailing of humeral shaft fractures--a meta-analysis. Acta Orthop. 2006 Apr;77(2):279-84. doi: 10.1080/17453670610046037.'}, {'pmid': '21678350', 'type': 'RESULT', 'citation': 'Kurup H, Hossain M, Andrew JG. Dynamic compression plating versus locked intramedullary nailing for humeral shaft fractures in adults. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD005959. doi: 10.1002/14651858.CD005959.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to determine the best surgical treatment for humeral shaft fractures. One third of the patients will be treated with open reduction and internal fixation with plate; one third, with bridge plate technique and the remaining third with locked intramedullary nail.', 'detailedDescription': 'Humerus diaphyseal fractures are amongst the most common of the appendicular skeleton. Despite the fact that the conservative treatment is still the gold standard for the majority of these fractures, this method was not proven to be superior when compared to the surgical treatment. Surgical options for the treatment of humeral shaft fractures range from open reduction and internal fixation with plate to minimally invasive methods (bridge plate and intramedullary nail) and the best method has yet to be determined. The goal of this study is to determine the best surgical option for the treatment of humeral shaft fractures. For this, will be recruited 105 patients with humeral shaft fractures, wich will be allocated, randomly, in 3 distinct groups. Each patient will be submitted to one of three possible methods of humerus osteosynthesis: open reduction and internal fixation with plate (ORIF), closed reduction and fixation with bridge plate or closed reduction and fixation with intramedullary nail. All data will be paired according to the age, gender, fracture classification, patient comorbidities and smoking habit. The Pearson\'s chi-square" test will be used to analyze the results of the three groups regarding categorical variables, and Student t-test (parametric) will be used to compare groups with respect to the numerical variables. The investigators expect to conclude that the methods of minimally invasive osteosynthesis of humeral shaft fractures have similar or better functional and radiographic outcomes, compared to the method of open reduction and internal fixation with a plate, with lesser risk of complications and an earlier return to activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complete fracture with angulation greater than 20 degrees, rotation greater than 30 degrees and/or shortening greater than 3 cm.\n* Fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of the medullary canal.\n\nExclusion Criteria:\n\n* fractures older than 3 weeks\n* pathologic fractures\n* fractures with extension to elbow or shoulder joint\n* patients with ipsilateral upper extremity fracture or injury\n* fractures with associated neurologic injury\n* patients with previous pathology of the shoulder, arm or elbow that cause pain or range of motion limitation\n* patients who do not agree with the terms of the study'}, 'identificationModule': {'nctId': 'NCT02418260', 'briefTitle': 'Surgical Interventions for the Treatment of Humeral Shaft Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Surgical Interventions for the Treatment of Humeral Shaft Fractures: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '24997313.8.0000.5505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open reduction and plate osteosynthesis', 'description': 'Open reduction and internal fixation with DCP 4.5mm plate.', 'interventionNames': ['Procedure: Open reduction and plate osteosynthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Bridge Plate', 'description': 'Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)', 'interventionNames': ['Procedure: Bridge Plate osteosynthesis']}, {'type': 'EXPERIMENTAL', 'label': 'Intramedullary nail', 'description': 'Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.', 'interventionNames': ['Procedure: Locked intramedullary nail osteosynthesis']}], 'interventions': [{'name': 'Bridge Plate osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['Bridge Plate'], 'description': 'Trough two anterior skin incisions, the 4.5mm narrow DCP plate will be placed on the anterior surface of the humerus and, after indirect reduction, it will be fixed to the bone with 2 proximal and 2 distal screws.', 'armGroupLabels': ['Bridge Plate']}, {'name': 'Locked intramedullary nail osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['IMN'], 'description': 'Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.', 'armGroupLabels': ['Intramedullary nail']}, {'name': 'Open reduction and plate osteosynthesis', 'type': 'PROCEDURE', 'otherNames': ['ORIF'], 'description': 'Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.', 'armGroupLabels': ['Open reduction and plate osteosynthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04038001', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rafael Pierami, M.D.', 'role': 'CONTACT', 'email': 'rafael_pierami@hotmail.com', 'phone': '+5511982325308'}, {'name': 'Marcel JS Tamaoki, Ph.D.', 'role': 'CONTACT', 'email': 'marceltamaoki@terra.com.br', 'phone': '+5511941713337'}], 'facility': 'Hand and Upper Limb Surgery Discipline', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Rafael Pierami, M.D.', 'role': 'CONTACT', 'email': 'rafael_pierami@hotmail.com', 'phone': '+5511982325308'}, {'name': 'Marcel JS Tamaoki, Ph.D.', 'role': 'CONTACT', 'email': 'marceltamaoki@terra.com.br', 'phone': '+5511941713337'}], 'overallOfficials': [{'name': 'Rafael Pierami', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rafael Pierami, M.D.', 'investigatorFullName': 'Rafael Pierami', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}