Operative and Nonoperative Treatment of Humeral Shaft Fractures

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal fixation (ORIF). The study will examine which treatment will overall give better results in regards to shoulder and elbow function, residual pain and deformity.

Patients who agree to consent to participation in this study will be randomly selected to receive one of the two treatment methods:

1. Nonoperative: This method requires the application of a plaster sugartong splint for 10 - 14 days followed by a transition to a functional (coaptation) brace to be worn for 4-6 weeks. Patients will be followed by physiotherapy from the baseline visit at 2 weeks.
2. Operative: This treatment option involves an operative procedure for fixation of the broken bone with plates and screws (open reduction internal fixation - ORIF). With this method of treatment, a splint or sling is worn for comfort postoperatively. The patient will be followed by physiotherapy after the post-operative visit at 2 weeks.

Standard follow-up clinic visits at 2 weeks, 6 weeks, 4 months, 6 months and 12 months will be arranged from the date of randomization. The patient will be asked to complete two questionnaires, reporting the level of wellbeing and physical function. These questionnaires will be given to the patient at the time of baseline visit at 2 weeks and again at 6 weeks, 4 months, 6 months and 12 months. They should take approximately 10 - 20 minutes to complete. At each appointment, the patients will be x-rayed until healing has occurred, examined and evaluated (Constant Shoulder Score) by the surgeon and followed by physiotherapy for gentle range of motion (ROM) exercises progressing to strengthening and proprioception of the elbow and shoulder.

Condition or disease	Intervention/treatment	Phase
Humeral Diaphyseal Fracture	Procedure: Open reduction and internal fixation (ORIF); Other: Non-surgical	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Prospective Trial Comparing Operative and Nonoperative Treatment of Humeral Shaft Fractures
Actual Study Start Date :	August 19, 2009
Estimated Primary Completion Date :	May 2019
Estimated Study Completion Date :	December 2020

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Surgical; Surgical intervention: open reduction and internal fixation (ORIF)	Procedure: Open reduction and internal fixation (ORIF); Antero-latero or posterior surgical approach using dynamic compression plate; Other Name: Plate with locking screws can be used.
Active Comparator: Non-surgical; Sugartong splint followed by transition to functional co-aptation brace	Other: Non-surgical; Sugartong splint followed by transition to functional co-aptation brace

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Validated functional outcome tools to be used: disability shoulder, arm, hand (DASH), short musculoskeletal functional assessment (SMFA) and Constant Shoulder Score. [ Time Frame: 2 and 6 weeks, 4, 6 and 12 months ]

Secondary Outcome Measures :

1. Range of Motion will be measured with a goniometer for both the shoulder/elbow with comparative values taken for a contralateral shoulder/elbow. [ Time Frame: 2 and 6 weeks; 4, 6 and 12 months ]
2. Radiologic Outcome: Antero-posterior and lateral radiographs [ Time Frame: 2 and 6 weeks; 4, 6 and 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Over 18 y/o with skeletal maturity, and consenting to participate
2. A displaced fracture of the humeral diaphysis amenable to fixation with a plate with no other injuries to the same limb
3. 21 days or less between injury and surgery
4. Medically fit for anaesthesia
5. The mental faculties to participate in post-op evaluation
6. Fracture amenable to both treatment methods

Exclusion Criteria:

1. Open fracture
2. Neurovascular injury requiring repair in the same limb (excluding radial nerve palsy)
3. Active infection in the area of the surgical approach
4. Prior injury, degenerative condition, or congenital condition to the shoulder, arm or elbow
5. Bone disorder which may impair bone healing
6. Polytrauma with other limb fractures
7. Incapable of ensuring follow-up
8. Pathologic fracture
9. Already enrolled in another research clinical trial

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Mary Amedeo	514-934-1934 ext 43386	mary.amedeo@muhc.mcgill.ca
Contact: Gregory K. Berry, MDCM FRCSC	514-934-1934 ext 42266	gregberry1@mac.com

Locations

Canada, Quebec
McGill University Health Centre - Montreal General Hospital	Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Mary Amedeo 514-934-1934 ext 43386 mary.amedeo@muhc.mcgill.ca
Contact: Gregory K. Berry, MCDM FRCSC 514-934-1934 ext 42266 gregberry1@mac.com
Principal Investigator: Gregory K. Berry, MDCM FRCSC

Sponsors and Collaborators

McGill University Health Center

Canadian Orthopaedic Trauma Society

Investigators

Principal Investigator:	Gregory K. Berry, MDCM FRCSC	McGill University Health Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Crolla RM, de Vries LS, Clevers GJ. Locked intramedullary nailing of humeral fractures. Injury. 1993 Jul;24(6):403-6.

Tytherleigh-Strong G, Walls N, McQueen MM. The epidemiology of humeral shaft fractures. J Bone Joint Surg Br. 1998 Mar;80(2):249-53.

Ekholm R, Adami J, Tidermark J, Hansson K, Törnkvist H, Ponzer S. Fractures of the shaft of the humerus. An epidemiological study of 401 fractures. J Bone Joint Surg Br. 2006 Nov;88(11):1469-73.

Ekholm R, Tidermark J, Törnkvist H, Adami J, Ponzer S. Outcome after closed functional treatment of humeral shaft fractures. J Orthop Trauma. 2006 Oct;20(9):591-6.

BANDI W. [INDICATION TO AND TECHNIC FOR OSTEOSYNTHESIS IN THE SHOULDER]. Helv Chir Acta. 1964 Jan;31:89-100. German.

Sarmiento A, Waddell JP, Latta LL. Diaphyseal humeral fractures: treatment options. Instr Course Lect. 2002;51:257-69. Review.

Rosenberg N, Soudry M. Shoulder impairment following treatment of diaphysial fractures of humerus by functional brace. Arch Orthop Trauma Surg. 2006 Sep;126(7):437-40. Epub 2006 Jun 21.

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.

Hunter SG. The closed treatment of fractures of the humeral shaft. Clin Orthop Relat Res. 1982 Apr;(164):192-8.

Rüedi T, Moshfegh A, Pfeiffer KM, Allgöwer M. Fresh fractures of the shaft of the humerus--conservative or operative treatment? Reconstr Surg Traumatol. 1974;14(0):65-74.

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.

Sarmiento A, Zagorski JB, Zych GA, Latta LL, Capps CA. Functional bracing for the treatment of fractures of the humeral diaphysis. J Bone Joint Surg Am. 2000 Apr;82(4):478-86.

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.

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.

McCormack RG, Brien D, Buckley RE, McKee MD, Powell J, Schemitsch EH. Fixation of fractures of the shaft of the humerus by dynamic compression plate or intramedullary nail. A prospective, randomised trial. J Bone Joint Surg Br. 2000 Apr;82(3):336-9.

Rockwood CA, Jr, Green DP. Fractures in Adults. Fourth Edition. Philadelphia. Lippincott-Raven, p 1025-53, 1996

Chapman JR, Henley MB, Agel J, Benca PJ. Randomized prospective study of humeral shaft fracture fixation: intramedullary nails versus plates. J Orthop Trauma. 2000 Mar-Apr;14(3):162-6.

Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10.

Buckley R, Tough S, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial. J Bone Joint Surg Am. 2002 Oct;84-A(10):1733-44.

Csizy M, Buckley R, Tough S, Leighton R, Smith J, McCormack R, Pate G, Petrie D, Galpin R. Displaced intra-articular calcaneal fractures: variables predicting late subtalar fusion. J Orthop Trauma. 2003 Feb;17(2):106-12.

Howard JL, Buckley R, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Complications following management of displaced intra-articular calcaneal fractures: a prospective randomized trial comparing open reduction internal fixation with nonoperative management. J Orthop Trauma. 2003 Apr;17(4):241-9.

Sanders R. Orthopaedic trauma societies and the multicenter trial. J Orthop Trauma. 2006 Jul;20(6):377.

Canadian Orthopaedic Trauma Society. Reamed versus unreamed intramedullary nailing of the femur: comparison of the rate of ARDS in multiple injured patients. J Orthop Trauma. 2006 Jul;20(6):384-7.

Responsible Party:	Greg K. Berry, MD, MDCM FRCSC, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00878319 History of Changes
Other Study ID Numbers:	SDR-08-055
First Posted:	April 8, 2009
Last Update Posted:	February 14, 2018
Last Verified:	February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Greg K. Berry, MD, McGill University Health Center:

Humeral; diaphyseal (mid-shaft); fracture; operative; non-operative

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries