Operative and Nonoperative Treatment of Humeral Shaft Fractures

NCT00878319 | Completed

• 1 other identifier: SDR-08-055
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Humeral Diaphyseal Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Validated functional outcome tools to be used: disability shoulder, arm, hand (DASH), short musculoskeletal functional assessment (SMFA) and Constant Shoulder Score.

  2 and 6 weeks, 4, 6 and 12 months

Secondary Outcomes (2)

• Range of Motion will be measured with a goniometer for both the shoulder/elbow with comparative values taken for a contralateral shoulder/elbow.

  2 and 6 weeks; 4, 6 and 12 months

• Radiologic Outcome: Antero-posterior and lateral radiographs

  2 and 6 weeks; 4, 6 and 12 months

Study Arms (2)

Surgical

ACTIVE COMPARATOR

Surgical intervention: open reduction and internal fixation (ORIF)

Procedure: Open reduction and internal fixation (ORIF)

Non-surgical

ACTIVE COMPARATOR

Sugartong splint followed by transition to functional co-aptation brace

Other: Non-surgical

Interventions

Open reduction and internal fixation (ORIF) PROCEDURE

Antero-latero or posterior surgical approach using dynamic compression plate

Also known as: Plate with locking screws can be used.

Surgical

Non-surgical OTHER

Sugartong splint followed by transition to functional co-aptation brace

Non-surgical

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Orthopaedic Trauma Society: collaborator

Study Sites (1)

McGill University Health Centre - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (23)

• Crolla RM, de Vries LS, Clevers GJ. Locked intramedullary nailing of humeral fractures. Injury. 1993 Jul;24(6):403-6. doi: 10.1016/0020-1383(93)90106-g.

  PMID: 8406748 BACKGROUND

• Tytherleigh-Strong G, Walls N, McQueen MM. The epidemiology of humeral shaft fractures. J Bone Joint Surg Br. 1998 Mar;80(2):249-53. doi: 10.1302/0301-620x.80b2.8113.

  PMID: 9546454 BACKGROUND

• Ekholm R, Adami J, Tidermark J, Hansson K, Tornkvist 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. doi: 10.1302/0301-620X.88B11.17634.

  PMID: 17075092 BACKGROUND

• 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: 17088659 BACKGROUND

• BANDI W. [INDICATION TO AND TECHNIC FOR OSTEOSYNTHESIS IN THE SHOULDER]. Helv Chir Acta. 1964 Jan;31:89-100. No abstract available. German.

  PMID: 14128305 BACKGROUND

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

  PMID: 12064111 BACKGROUND

• 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. doi: 10.1007/s00402-006-0167-9. Epub 2006 Jun 21.

  PMID: 16810551 BACKGROUND

• 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: 11988725 BACKGROUND

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

  PMID: 7067285 BACKGROUND

• Ruedi T, Moshfegh A, Pfeiffer KM, Allgower M. Fresh fractures of the shaft of the humerus--conservative or operative treatment? Reconstr Surg Traumatol. 1974;14(0):65-74. No abstract available.

  PMID: 4843035 BACKGROUND

• 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: 873955 BACKGROUND

• 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. doi: 10.2106/00004623-200004000-00003.

  PMID: 10761938 BACKGROUND

• 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: 9258827 BACKGROUND

• 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: 3356728 BACKGROUND

• 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. doi: 10.1302/0301-620x.82b3.9675.

  PMID: 10813165 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1097/00005131-200003000-00002.

  PMID: 10791665 BACKGROUND

• 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. doi: 10.2106/JBJS.F.00020.

  PMID: 17200303 BACKGROUND

• 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(10):1733-44. doi: 10.2106/00004623-200210000-00001.

  PMID: 12377902 BACKGROUND

• 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. doi: 10.1097/00005131-200302000-00005.

  PMID: 12571499 BACKGROUND

• 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. doi: 10.1097/00005131-200304000-00001.

  PMID: 12679683 BACKGROUND

• Sanders R. Orthopaedic trauma societies and the multicenter trial. J Orthop Trauma. 2006 Jul;20(6):377. doi: 10.1097/00005131-200607000-00001. No abstract available.

  PMID: 16825960 BACKGROUND

• 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. doi: 10.1097/00005131-200607000-00003.

  PMID: 16825962 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Open Fracture Reduction; Fracture Fixation, Internal; Bone Plates

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Gregory K. Berry, MDCM FRCSC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDCM FRCSC

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: August 19, 2009
• Primary Completion: February 4, 2020
• Study Completion: February 1, 2023
• Last Updated: February 14, 2025

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)