NCT02418260

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

5 years

First QC Date

April 8, 2015

Last Update Submit

October 4, 2017

Conditions

Fracture of Shaft of HumerusHumerus Fracture

Keywords

Humerusshaftdiaphysealfractures

Outcome Measures

Primary Outcomes (1)

  • Changes in the Disabilities of the Arm, Shoulder and Hand (DASH)

    The survey will be applied at 8, 24 and 48 weeks after the intervention

    48 weeks

Secondary Outcomes (6)

  • Changes in the Visual Analog Scale for Pain (VAS)

    48 weeks

  • Changes in the Constant-Murley Shoulder Outcome Score

    48 weeks

  • Complications (nonunion, symptomatic malunion, hardware related issues, shoulder pain, infection, neurological injury and loss of range of motion of shoulder and/or elbow)

    48 weeks

  • Radiographic angular deformity

    at 48 weeks

  • Time to previous activities return

    48 weeks

  • +1 more secondary outcomes

Study Arms (3)

Open reduction and plate osteosynthesis

ACTIVE COMPARATOR

Open reduction and internal fixation with DCP 4.5mm plate.

Procedure: Open reduction and plate osteosynthesis

Bridge Plate

EXPERIMENTAL

Patients will be submitted to closed reduction and anterior bridge plate osteosynthesis (narrow 4.5mm DCP plate will be used)

Procedure: Bridge Plate osteosynthesis

Intramedullary nail

EXPERIMENTAL

Patients will be submitted to closed reduction and locked intramedullary nail osteosynthesis.

Procedure: Locked intramedullary nail osteosynthesis

Interventions

Bridge Plate osteosynthesisPROCEDURE

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.

Also known as: Bridge Plate
Bridge Plate
Locked intramedullary nail osteosynthesisPROCEDURE

Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.

Also known as: IMN
Intramedullary nail
Open reduction and plate osteosynthesisPROCEDURE

Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.

Also known as: ORIF
Open reduction and plate osteosynthesis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Complete fracture with angulation greater than 20 degrees, rotation greater than 30 degrees and/or shortening greater than 3 cm.
  • Fractures located from 4 cm distal to the surgical neck to 2 cm proximal to the end of the medullary canal.

You may not qualify if:

  • fractures older than 3 weeks
  • pathologic fractures
  • fractures with extension to elbow or shoulder joint
  • patients with ipsilateral upper extremity fracture or injury
  • fractures with associated neurologic injury
  • patients with previous pathology of the shoulder, arm or elbow that cause pain or range of motion limitation
  • patients who do not agree with the terms of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hand and Upper Limb Surgery Discipline

São Paulo, 04038001, Brazil

RECRUITING

Related Publications (43)

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    PMID: 14261543BACKGROUND

  • 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.

    PMID: 7105548BACKGROUND

  • McKee MD LS. Humeral Shaft Fractures. Rockwood and Green's Fractures in Adults. 7th ed. Philadelphia: Lippincot Williams & Wilkins; 2009

    BACKGROUND

  • 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: 10341891BACKGROUND

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    PMID: 11407801BACKGROUND

  • 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.

    PMID: 21350618BACKGROUND

  • Solway S, Beaton, D.E., McConnell, S., & Bombardier, C. The DASH Outcome measure user's manual (2nd Edition). Institute for Work & Health. Toronto2002.

    BACKGROUND

  • 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: 15785841BACKGROUND

  • 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: 2039061BACKGROUND

  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

    PMID: 3791738BACKGROUND

  • 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: 7838503RESULT

  • 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.

    PMID: 873955RESULT

  • Ward EF SF, Hughes JL. Fractures of the diaphyseal humerus. In: Saunders, ed. Skeletal trauma: fractures, dislocation, ligamentous injuries. Philadelphia: Saunders; 1998:1523-47

    RESULT

  • 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: 7054192RESULT

  • 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: 8326423RESULT

  • 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: 8423295RESULT

  • 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: 7462281RESULT

  • 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: 17088659RESULT

  • 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: 17088660RESULT

  • 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: 17079389RESULT

  • 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: 22258990RESULT

  • 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: 19523625RESULT

  • 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: 3356728RESULT

  • 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: 9258827RESULT

  • 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: 10853896RESULT

  • 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: 11988725RESULT

  • 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: 4066292RESULT

  • 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: 17452711RESULT

  • 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: 9498146RESULT

  • 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: 3980544RESULT

  • 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: 1556609RESULT

  • 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: 8355300RESULT

  • 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: 21915231RESULT

  • 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: 15714304RESULT

  • 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: 11600115RESULT

  • 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: 15168178RESULT

  • 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: 22659630RESULT

  • 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: 22144745RESULT

  • 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: 22947239RESULT

  • 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: 23994004RESULT

  • 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: 23471713RESULT

  • 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: 16752291RESULT

  • 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.

    PMID: 21678350RESULT

MeSH Terms

Conditions

Humeral FracturesFractures, Bone

Interventions

Open Fracture Reduction

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Rafael Pierami

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafael Pierami, M.D.

CONTACT

+5511982325308rafael_pierami@hotmail.com

Marcel JS Tamaoki, Ph.D.

CONTACT

+5511941713337marceltamaoki@terra.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rafael Pierami, M.D.

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 16, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

BR(1)